The report on the global Progenitor Cell Product market is comprehensively prepared with main focus on the competitive landscape, geographical growth, segmentation, and market dynamics, including drivers, restraints, and opportunities. It sheds light on key production, revenue, and consumption trends so that players could improve their sales and growth in the GlobalProgenitor Cell Product Market.It brings to light key factors affecting the growth of different segments and regions in the global Progenitor Cell Product market. It also offers SWOT, Porters Five Forces, and PESTLE analysis to thoroughly examine the global Progenitor Cell Product market.It offers a detailed analysis of the competition and leading companies of the global Progenitor Cell Product market. Here, it concentrates on the recent developments, sales, market value, production, gross margin, and other important factors of the business of top players operating in the global Progenitor Cell Product market.

Key companies operating in the global Progenitor Cell Product market include:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

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With deep quantitative and qualitative analysis, the report provides encyclopedic and accurate research study on important aspects of the global Progenitor Cell Product market. It gives a detailed study on manufacturing cost, upstream and downstream buyers, distributors, marketing strategy, and marketing channel development trends of the global Progenitor Cell Product market. Furthermore, it provides strategic bits of advice and recommendations for players to ensure success in the global Progenitor Cell Product market.

Segmental Analysis

The report has classified the global Progenitor Cell Product industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Progenitor Cell Product manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Progenitor Cell Product industry.

Global Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

Global Progenitor Cell Product Market Segment By Application:

Progenitor Cell Product

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Progenitor Cell Product industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Progenitor Cell Product market includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Regions and Countries

The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Key Questions Answered

What is the size and CAGR of the global Progenitor Cell Product market?

Which are the leading segments of the global Progenitor Cell Product market?

What are the key driving factors of the most profitable regional market?

What is the nature of competition in the global Progenitor Cell Product market?

How will the global Progenitor Cell Product market advance in the coming years?

What are the main strategies adopted in the global Progenitor Cell Product market?

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Table of Contents

Table of Contents 1 Progenitor Cell Product Market Overview1.1 Progenitor Cell Product Product Overview1.2 Progenitor Cell Product Market Segment by Type1.2.1 Pancreatic progenitor cells1.2.2 Cardiac Progenitor Cells1.2.3 Intermediate progenitor cells1.2.4 Neural progenitor cells (NPCs)1.2.5 Endothelial progenitor cells (EPC)1.2.6 Others1.3 Global Progenitor Cell Product Market Size by Type1.3.1 Global Progenitor Cell Product Sales and Growth by Type1.3.2 Global Progenitor Cell Product Sales and Market Share by Type1.3.3 Global Progenitor Cell Product Revenue and Market Share by Type1.3.4 Global Progenitor Cell Product Price by Type1.4 North America Progenitor Cell Product by Type1.5 Europe Progenitor Cell Product by Type1.6 South America Progenitor Cell Product by Type1.7 Middle East and Africa Progenitor Cell Product by Type 2 Global Progenitor Cell Product Market Competition by Company2.1 Global Progenitor Cell Product Sales and Market Share by Company (2014-2019)2.2 Global Progenitor Cell Product Revenue and Share by Company (2014-2019)2.3 Global Progenitor Cell Product Price by Company (2014-2019)2.4 Global Top Players Progenitor Cell Product Manufacturing Base Distribution, Sales Area, Product Types2.5 Progenitor Cell Product Market Competitive Situation and Trends2.5.1 Progenitor Cell Product Market Concentration Rate2.5.2 Global Progenitor Cell Product Market Share of Top 5 and Top 10 Players2.5.3 Mergers & Acquisitions, Expansion 3 Progenitor Cell Product Company Profiles and Sales Data3.1 NeuroNova AB3.1.1 Company Basic Information, Manufacturing Base and Competitors3.1.2 Progenitor Cell Product Product Category, Application and Specification3.1.3 NeuroNova AB Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.1.4 Main Business Overview3.2 StemCells3.2.1 Company Basic Information, Manufacturing Base and Competitors3.2.2 Progenitor Cell Product Product Category, Application and Specification3.2.3 StemCells Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.2.4 Main Business Overview3.3 ReNeuron Limited3.3.1 Company Basic Information, Manufacturing Base and Competitors3.3.2 Progenitor Cell Product Product Category, Application and Specification3.3.3 ReNeuron Limited Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.3.4 Main Business Overview3.4 Asterias Biotherapeutics3.4.1 Company Basic Information, Manufacturing Base and Competitors3.4.2 Progenitor Cell Product Product Category, Application and Specification3.4.3 Asterias Biotherapeutics Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.4.4 Main Business Overview3.5 Thermo Fisher Scientific3.5.1 Company Basic Information, Manufacturing Base and Competitors3.5.2 Progenitor Cell Product Product Category, Application and Specification3.5.3 Thermo Fisher Scientific Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.5.4 Main Business Overview3.6 STEMCELL Technologies3.6.1 Company Basic Information, Manufacturing Base and Competitors3.6.2 Progenitor Cell Product Product Category, Application and Specification3.6.3 STEMCELL Technologies Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.6.4 Main Business Overview3.7 Axol Bio3.7.1 Company Basic Information, Manufacturing Base and Competitors3.7.2 Progenitor Cell Product Product Category, Application and Specification3.7.3 Axol Bio Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.7.4 Main Business Overview3.8 R&D Systems3.8.1 Company Basic Information, Manufacturing Base and Competitors3.8.2 Progenitor Cell Product Product Category, Application and Specification3.8.3 R&D Systems Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.8.4 Main Business Overview3.9 Lonza3.9.1 Company Basic Information, Manufacturing Base and Competitors3.9.2 Progenitor Cell Product Product Category, Application and Specification3.9.3 Lonza Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.9.4 Main Business Overview3.10 ATCC3.10.1 Company Basic Information, Manufacturing Base and Competitors3.10.2 Progenitor Cell Product Product Category, Application and Specification3.10.3 ATCC Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.10.4 Main Business Overview3.11 Irvine Scientific3.12 CDI 4 Progenitor Cell Product Market Status and Outlook by Regions4.1 Global Progenitor Cell Product Market Status and Outlook by Regions4.1.1 Global Progenitor Cell Product Market Size and CAGR by Regions4.1.2 North America4.1.3 Europe4.1.4 Asia-Pacific4.1.5 South America4.1.6 Middle East and Africa4.2 Global Progenitor Cell Product Sales and Revenue by Regions4.2.1 Global Progenitor Cell Product Sales Market Share by Regions (2014-2019)4.2.2 Global Progenitor Cell Product Revenue Market Share by Regions (2014-2019)4.2.3 Global Progenitor Cell Product Sales, Revenue, Price and Gross Margin (2014-2019)4.3 North America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.3.1 North America Progenitor Cell Product Sales by Countries4.3.2 United States4.3.3 Canada4.3.4 Mexico4.4 Europe Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.4.1 Europe Progenitor Cell Product Sales by Countries4.4.2 Germany4.4.3 France4.4.4 UK4.4.5 Italy4.4.6 Russia4.5 Asia-Pacific Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.5.1 Asia-Pacific Progenitor Cell Product Sales by Regions4.5.2 China4.5.3 Japan4.5.4 South Korea4.5.5 India4.5.6 Australia4.5.7 Indonesia4.5.8 Thailand4.5.9 Malaysia4.5.10 Philippines4.5.11 Vietnam4.6 South America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.6.1 South America Progenitor Cell Product Sales by Countries4.6.2 Brazil4.7 Middle East and Africa Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.7.1 Middle East and Africa Progenitor Cell Product Sales by Countries4.7.2 Turkey4.7.3 GCC Countries4.7.4 Egypt4.7.5 South Africa 5 Progenitor Cell Product Application5.1 Progenitor Cell Product Segment by Application5.1.1 Medical care5.1.2 Hospital5.1.3 Laboratory5.2 Global Progenitor Cell Product Product Segment by Application5.2.1 Global Progenitor Cell Product Sales by Application5.2.2 Global Progenitor Cell Product Sales and Market Share by Application (2014-2019)5.3 North America Progenitor Cell Product by Application5.4 Europe Progenitor Cell Product by Application5.5 Asia-Pacific Progenitor Cell Product by Application5.6 South America Progenitor Cell Product by Application5.7 Middle East and Africa Progenitor Cell Product by Application 6 Global Progenitor Cell Product Market Forecast6.1 Global Progenitor Cell Product Sales, Revenue Forecast (2019-2025)6.1.1 Global Progenitor Cell Product Sales and Growth Rate Forecast (2019-2025)6.1.2 Global Progenitor Cell Product Revenue and Growth Rate Forecast (2019-2025)6.2 Global Progenitor Cell Product Forecast by Regions6.2.1 North America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.2 Europe Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.3 Asia-Pacific Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.4 South America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.5 Middle East and Africa Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.3 Progenitor Cell Product Forecast by Type6.3.1 Global Progenitor Cell Product Sales and Revenue Forecast by Type (2019-2025)6.3.2 Pancreatic progenitor cells Growth Forecast6.3.3 Cardiac Progenitor Cells Growth Forecast6.4 Progenitor Cell Product Forecast by Application6.4.1 Global Progenitor Cell Product Sales Forecast by Application (2019-2025)6.4.2 Global Progenitor Cell Product Forecast in Medical care6.4.3 Global Progenitor Cell Product Forecast in Hospital 7 Progenitor Cell Product Upstream Raw Materials7.1 Progenitor Cell Product Key Raw Materials7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price7.1.3 Raw Materials Key Suppliers7.2 Manufacturing Cost Structure7.2.1 Raw Materials7.2.2 Labor Cost7.2.3 Manufacturing Expenses7.3 Progenitor Cell Product Industrial Chain Analysis 8 Marketing Strategy Analysis, Distributors8.1 Sales Channel8.2 Distributors8.3 Downstream Customers 9 Research Findings and Conclusion 10 Appendix10.1 Methodology/Research Approach10.1.1 Research Programs/Design10.1.2 Market Size Estimation10.1.3 Market Breakdown and Data Triangulation10.2 Data Source10.2.1 Secondary Sources10.2.2 Primary Sources10.3 Author List10.4 Disclaimer

About Us:

QYResearch always pursuits high product quality with the belief that quality is the soul of business. Through years of effort and supports from the huge number of customer supports, QYResearch consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience. Today, QYResearch has become a brand of quality assurance in the consulting industry.

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Progenitor Cell Product Market 2020| Worldwide Industry Share, Size, Gross Margin, Trend, Future Demand, Analysis by Top Leading Player and Forecast...

Cardiac Stem Cells Comments Off on Progenitor Cell Product Market 2020| Worldwide Industry Share, Size, Gross Margin, Trend, Future Demand, Analysis by Top Leading Player and Forecast… | May 16th, 2020

Therapeutic Activities of Engrafted Neural Stem/Precursor Cells Are Not Dormant in the Chronically Injured Spinal Cord

From Stem Cells

Neural stem or precursor cells (NSPCs) have tremendous promise for use in cell-based therapies for the treatment of spinal cord injury (SCI) as they have been shown to provide trophic support following transplantation, allowing modification of the host environment to allow some endogenous regeneration and repair in animal models (Aboodyet al,Barnabe-Heider and Frisen, andMartino and Pluchino). However, few studies have assessed their role in the chronic phase of SCI (Tetzlaffet al) and any correlation to microenvironmental factors (Thuretet al), which is potentially important for the behaviour of transplanted NSPCs. Now, in a study published inStem Cellsfrom the laboratory of Seiji Okada at Kyushu University, Japan,Kumamaruet alcombine flow-cytometric isolation and RNA-Seq to analyse the transcriptome of NSPCs transplanted into SCI during the chronic phase, and have demonstrated that while the cells have a positive therapeutic effect, the refractory state of the chronically injured spinal cord hampers locomotory recovery.

To determine the chronic phase of SCI, a time course of the change in the number of inflammatory cells until 3 months after SCI was assessed. Neutrophil infiltration peaked at 12 hours and subsequently decreased, microglia increased and peaked at 6 weeks, while macrophages and monocytes first peaked at 12 hours and then again at 6 weeks. Gene expression analysis over the same time period found that levels of pro-inflammatory factors, anti-inflammatory factors, CXC chemokine ligands and CC chemokine ligands and growth and neurotrophic factors were very different between the acute (enriched in inflammatory cytokine/chemokines and neurotrophic factors) and the chronic (enriched in growth factors) stages of SCI. Next, Luciferase and GFP-labeled NSPCs were transplanted 3 months after SCI, where long-term cell viability was observed and graft survival rate of around 17% was observed at 42 days after transplantation. Transplanted NSPCs migrated up to 4mm rostrally or caudally from the graft site and had extended fine cellular processes. Chondroitin sulfate proteoglycans (CSPGs) are potent inhibitors of transplanted cell migration and survival and have been linked to transplant failure during the chronic phase (Karimi-Abdolrezaee et al). Analysis found that while CSPGs were abundant during the sub-acute phase of SCI, this reduced to normal levels at three months.

Subsequent RNA-Seq analysis of NSPCs analysed at 7 days after transplantation during the acute, sub-acute, and chronic phases of SCI found, as observed previously (Kumamaru et al), that transcriptional activity is reduced in NSPCs transplanted into the acutely injured spinal cord compared to those transplanted into nave spinal cords, however this reduction was not observed for the sub-acute and chronic phases, and increased transcriptional activity was observed in chronically transplanted NSPCs. Principal component analysis then suggested that sub-acutely injured spinal cords may promote the oligodendrocyte differentiation of transplanted NSPCs whereas chronically injured spinal cords promoted neuronal differentiation. Analysis of differentiation-associated gene expression found that chronically injured spinal cords were permissive for the differentiation of engrafted NSPCs with overexpressed genes representing neurogenesis and neuronal differentiation. Oligodendrocyte generation by engrafted NSPCs was not however inhibited in chronic SCI microenvironments but was more prominent in sub-acute SCI. Secreted molecules, which can act as trophic mediators, decreased markedly in acutely injured spinal cords but increased in chronically injured spinal cords. Finally, functional improvement was analysed and, while NSPC transplantation in the acute and sub-acute groups showed significantly improved functional recovery, the chronically NSPC-transplanted mice did not exhibit improved locomotor recovery.

Overall, this study shows that NSPCs which are transplanted into chronic phase SCI sites survive, are migratory, transcriptionally active, undergo neuronal and oligodendrocyte differentiation and secrete trophic factors at a level higher than expected from a refractory site, BUT, ultimately do not improve locomotor function. This suggests that the micro-environment of SCI in the chronic phase itself is the main barrier to the potential regenerative effects of NSPC transplantation. With this knowledge in hand, therapies for this type of injury will hopefully continue to evolve to a state where cell therapy and environmental modulation can work hand in hand to affect functional recovery.

References

FromStem Cells.

Stem CellCorrespondent Stuart P Atkinson reports on those studies appearing in current journals that are destined to make an impact on stem cell research and clinical studies.

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Spinal Cord Treatment Problems Site not the Cells ...

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Statements in this Quarterly Report that are not strictly historical areforward-looking statements and include statements about products in development,results and analyses of pre-clinical studies, clinical trials and studies,research and development expenses, cash expenditures, and alliances andpartnerships, among other matters. You can identify these forward-lookingstatements because they involve our expectations, intentions, beliefs, plans,projections, anticipations, or other characterizations of future events orcircumstances. These forward-looking statements are not guarantees of futureperformance and are subject to risks and uncertainties that may cause actualresults to differ materially from those in the forward-looking statements as aresult of any number of factors. These factors include, but are not limited to,risks relating to our: ability to conduct and obtain successful results fromongoing pre-clinical and clinical trials, commercialize our technology, obtainregulatory approval for our product candidates, contract with third parties toadequately test and manufacture our proposed therapeutic products, protect ourintellectual property rights and obtain additional financing to continue ouroperations. Some of these factors are more fully discussed, as are otherfactors, in our Annual Report on Form 10-K for the fiscal year ended December31, 2019, as filed with the SEC, in our subsequent filings with the SEC as wellas in the section of this Quarterly Report entitled "Risk Factors" and elsewhereherein. We do not undertake to update any of these forward-looking statements orto announce the results of any revisions to these forward-looking statementsexcept as required by law.We urge you to read this entire Quarterly Report on Form 10-Q, including the"Risk Factors" section, the condensed consolidated financial statements, andrelated notes. As used in this Quarterly Report, unless the context otherwiserequires, the words "we," "us," "our," "the Company" and "Seneca" refers toSeneca Biopharma, Inc. and its subsidiary. Also, any reference to "commonshares" or "common stock," refers to our $.01 par value common stock. Anyreference to "Series A Preferred Stock" or "Preferred Stock" refers to ourSeries A 4.5% Convertible Preferred Stock. The information contained herein iscurrent as of the date of this Quarterly Report (March 31, 2020), unless anotherdate is specified. On July 17, 2019, we completed a 1-for-20 reverse stock splitof our common stock. All share and per shares information in this report havebeen adjusted to reflect the reverse stock split. We prepare our interimfinancial statements in accordance with U.S. GAAP. Our financials and results ofoperations for the three-month period ended March 31, 2020 are not necessarilyindicative of our prospective financial condition and results of operations forthe pending full fiscal year ending December 31, 2020. The interim financialstatements presented in this Quarterly Report as well as other informationrelating to our Company contained in this Quarterly Report should be read inconjunction and together with the reports, statements and information filed byus with the SEC.Our Management's Discussion and Analysis of Financial Condition and Results ofOperations or MD&A is provided, in addition to the accompanying condensedconsolidated financial statements and notes, to assist you in understanding ourresults of operations, financial condition and cash flows. Our MD&A is organizedas follows:

Executive Overview - Discussion of our business and overall analysis of

financial and other items affecting the Company in order to provide context for

Trends & Outlook - Discussion of what we view as the overall trends affecting

Critical Accounting Policies - Accounting policies that we believe are

important to understanding the assumptions and judgments incorporated in our

Results of Operations - Analysis of our financial results comparing the

three-month periods ended March 31, 2020 to the comparable period of 2019.

Liquidity and Capital Resources - An analysis of cash flows and discussion of

Our patented technology platform has three core components:

1. Over 300 lines of human, regionally specific neural stem cells, some of which

have the potential to be used to treat serious or life-threatening diseases

through direct transplantation into the central nervous system;

2. Proprietary screening capability - our ability to generate human neural stem

cell lines provides a platform for chemical screening and discovery of novel

compounds against nervous system disorders; and

3. Small molecules that resulted from Seneca's neurogenesis screening platform

To date, our technology platform has produced two lead assets in clinicaldevelopment: our NSI-566 stem cell therapy program and our NSI-189 smallmolecule program. A component of our current strategy is out-licensing and wehave recently initiated a formal out-licensing initiative aimed at securingpartners to advance the clinical development of these two programs.

In-licensing and Acquisition Strategy

Below is a description of our clinical programs, their intended indication andcurrent stage of development:

Motor Deficits Due to Ischemic Stroke

Amyotrophic Lateral Sclerosis

Chronic Spinal Cord Injury

Clinical Experience with NSI-566

Amyotrophic Lateral Sclerosis

Pre-Clinical Experience with NSI-566 and other candidates in our stem cellpipeline

NSI-189 (Small Molecule Pharmaceutical Compound)

Major Depressive Disorder (MDD)

Clinical Experience with NSI-189

Preclinical Experience with NSI-189

NSI-189 has shown promise in preclinical studies evaluating its impact in animalmodels for a number of different disease indications, including:

1. Ischemic stroke-in 2017 Tajiri and colleagues published a manuscript

reporting that NSI-189 ameliorated motor and neurological deficits in a

rodent model of ischemic stroke (Tajiri et al., J Cell Physiol 2017,

232(10):2731-2740)

2. Radiation-induced cognitive dysfunction-in 2018 Allen and colleagues

published a manuscript reporting that NSI-189 treatment could reverse

cognitive deficits in rats caused by cranial irradiation, a model of cranial

radiotherapy in the treatment of brain tumors (Allen et al., Radiat Res 2018,

189(4):345-353).

3. Angelman syndrome-in 2019 Liu and colleagues published a manuscript reporting

that NSI-189 reversed impairments in cognitive and motor deficits in a rodent

model of Angelman syndrome and increased synaptic strength in sections of

brains taken from these animals (Liu et al., Neuropharmacology 2019,

144:337-344). Angelman syndrome (AS) is a rare congenital genetic disorder

caused by a lack of function in the UBE3A gene on the maternal 15th

chromosome. It affects approximately one in 15,000 people - about 500,000

individuals globally. Symptoms of AS include developmental delay, lack of

speech, seizures, and walking and balance disorders.

4. Diabetes-associated peripheral neuropathy-in 2019 Jolivalt and colleagues

published a manuscript reporting that NSI-189 mitigated or reversed

disease-associated central and peripheral neuropathy in two rodent models of

diabetes (Jolivalt et al., Diabetes 2019, (11):2143-2154). Improvements

resulting from NSI-189 treatment were seen on multiple sensory and cognitive

Our Proprietary and Novel Screening Platform

Small Molecule Pharmaceutical Compounds.

In addition to patenting our technologies, we also rely on confidential andproprietary information and take active measures to control access to thatinformation, including the use of confidentiality agreements with our employees,consultants and certain of our contractors.

As of April 30, 2020, we had seven (7) full-time employees. We also use theservices of several outside consultants in business and scientific matters.

We generated no revenues from the sale of our proposed therapies for any of theperiods presented.

We have historically generated minimal revenue from the licensing of ourintellectual property to third parties as well as payments under a settlementagreement.

Research and Development Expenses

We have a wholly-owned subsidiary in the People's Republic of China thatprimarily oversees our current clinical trial to treat motor deficits due toischemic stroke.

General and Administrative Expenses

Comparison of Three Months Ended March 31, 2020 and 2019

Revenue

Operating expenses for the three months ended March 30 were as follows:

Research and Development Expenses

General and Administrative Expenses

Other income (expense)

Other expense, net totaled approximately ($5,585,000) and ($657,000) for thethree months ended March 31, 2020 and 2019, respectively.

Cash Flows - 2020 compared to 2019

Net cash used in operating activities $ (1,677,629 )$ (1,665,905 )$ (11,724 )

Net cash provided by financing activities $ 6,593,428$ (117,019 )$ 6,710,447

Net Cash Used in Operating Activities

Net Cash (Used in) Provided by Investing Activities

There were no investing activities in either of the three months ended March 31,2020 or 2019.

Net Cash Used in by Financing Activities

Edgar Online, source Glimpses

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SENECA BIOPHARMA : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) - marketscreener.com

Spinal Cord Stem Cells Comments Off on SENECA BIOPHARMA : MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) – marketscreener.com | May 16th, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--QurAlis Corporation, a biotech company focused on developing precision therapeutics for amyotrophic lateral sclerosis (ALS) and other neurologic diseases, today announced the raise of a $42 million Series A financing, bringing the total funds raised to $50.5 million. The financing was led by LS Polaris Innovation Fund, lead seed investor Mission BioCapital, INKEF Capital and the Dementia Discovery Fund, and co-led by Droia Ventures. Additional new investors include Mitsui Global Investment and Dolby Family Ventures, joined by investments from existing investors Amgen Ventures, MP Healthcare Venture Management, and Sanford Biosciences. QurAlis intends to use this funding to support the development of new therapies for ALS and genetically related frontotemporal dementia (FTD), neurodegenerative diseases for which there is currently no cure.

This Series A funding will allow us to take the next major step in our growth and advance our lead programs into the clinic. Recent advances in science and technology have identified strong disease targets for specific groups of ALS and FTD patients. Combined with our proprietary human stem cell technologies and development capabilities, we believe we are placed in a very good position to bring forth real treatments, said Kasper Roet, Ph.D., Chief Executive Officer of QurAlis. The QurAlis team built this company from the ground up on a foundation of cutting-edge science and profound dedication to helping ALS patients above all else. The great support of our existing and new investors from the US, Europe and Japan underscores the international nature of our mission. We plan to use this funding to continue advancing ALS and FTD therapies for patients around the world who are in critical need of effective treatments.

As ALS can be caused by mutations in over 25 individual human genes, many of which also cause FTD, QurAlis strategy is to systematically investigate treatments targeting specific disease-causing mechanisms in patient sub-populations. The company evaluates a wide range of potential treatments through the companys transformative system that utilizes lab-grown neuronal networks derived from cells of ALS patients.

Between the companys strong scientific foundation and support by ALS luminaries Kevin Eggan and his co-founders, promising pipeline of potential ALS treatments, and its dedicated team of experts in the field of neurologic therapeutics, QurAlis is very well positioned to make a tremendous difference for patients with ALS and FTD, said Amy Schulman, Managing Partner of the LS Polaris Innovation Fund. We are proud to support their mission and have deep faith in their transformative technology, which has already supported the discovery of several promising ALS candidate therapeutics.

In connection with the financing round, Amy Schulman, Managing Partner of the LS Polaris Innovation Fund; Roel Bulthuis, Managing Partner at INKEF Capital; Jonathan Behr, Ph.D., Partner at the Dementia Discovery Fund; and Luc Dochez, Managing Partner at DROIA Ventures, will be joining Johannes Fruehauf, M.D., Ph.D., General Partner at Mission BioCapital, on QurAlis Board.

About ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrigs disease, is a progressive neurodegenerative disease impacting nerve cells in the brain and spinal cord. ALS breaks down nerve cells, reducing muscle function and causing loss of muscle control. ALS can be traced to mutations in over 25 different genes and is often caused by a combination of multiple sub-forms of the condition. Its average life expectancy is three years, and there is currently no cure for the disease.

About QurAlis Corporation

QurAlis is developing precision therapeutics for ALS, a terminal disease that causes muscle paralysis through degeneration of the motor system. We are digging deep into the root causes of the multiple sub-forms of this destructive disease and focus our programs on tackling specific disease-causing mechanisms.

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QurAlis raises $42 Million Series A Financing to Develop New Therapies for Amyotrophic Lateral Sclerosis (ALS) - Business Wire

Spinal Cord Stem Cells Comments Off on QurAlis raises $42 Million Series A Financing to Develop New Therapies for Amyotrophic Lateral Sclerosis (ALS) – Business Wire | May 16th, 2020

MIKE TYSON has been doing the rounds to physically prepare for his sensational boxing comeback aged 53.

Tyson, who retired in 2005, has a whole new diet and cardio regime as well as going through a "weird" stem cell treatment.

3

It comes after the former heavyweight king announced plans to make a return to the ring to compete in exhibition bouts for charity, and has been training for the last month to do so.

Speaking to rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson explained the methods he is using to get back into fighting shape, as he revealed: "Really I would just change my diet and just do cardio work.

"Cardio has to start, you have to have your endurance to go and do the process of training.

"So something to do is get in cardio, I would try and get two hours of cardio a day, make sure you get that stuff in. Youre gonna make sure youre eating the right food.

"For me its almost like slave food. Doing what you hate to do but doing it like its nothing. Getting up when you dont want to get up.

"Thats what it is. Its becoming a slave to life.

"Being a slave to life means being the best person you can be, being the best you can possibly be, and when you are at the best you can possibly be is when you no longer exist and nobody talks about you. Thats when youre at your best."

Tyson's return to training for the first time in 15 years has been aided by stem-cell research therapy, that has left him feeling like a "different person".

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

Tyson was asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

Having previously claimed he feels in the best shape of his life, Tyson revealed he will be ready to fight again in just six weeks.

He said: "My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

Pictured

GARDEN PARTYEddie Hearn reveals plan to bring boxing back by hosting fights in his GARDEN

NO W-HAYEHaye snubs Mike Tyson in top 5 heavyweights of all time and details sad decline

BACK IN GLOVEHolyfield CONFIRMS Tyson talks over epic trilogy with pair close to deal

Revealed

MONEY MIKEMike Tyson's earnings from all his major fights revealed as he raked in 557m

BLOOD SPORTMike Tyson injected by docs with translucent blood that made him feel 'weird'

WEATHER THE STORMMayweather demands 500MILLION to make stunning boxing return

Exclusive

SON OF A GUNTeddy Atlas lost 30m after holding gun to Mike Tyson's head when he was 15

TONE IT DOWNTyson Fury is No1 in world but Anthony Joshua would beat him says Bellew

Pictured

KNOCKOUT BLONDEMeet Mila Kuznetsova, the plus-size model-turned-boxer with 34M boobs

During his reign as champion, Tyson would wake up at 4.30am to run before later heading to the gym where he would do 10-12 rounds of boxing mixed in with an array of muscles exercises.

His diet consisted of 3000-4000 calories of carbohydrates and proteins which helped fuel his training sessions.

Tyson, still the youngest heavyweight champion of all time at 20, retired with a record of 50-6-2 and remains one of the most celebrated punchers of all time.

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Brian Lindberg

Lockheed Martin Corporation has partnered with Be The Match to enable patients to continue receiving life-saving transplants without interruption during the COVID-19 pandemic by ensuring the timely delivery of bone marrow and blood stem cells for transplant, Lockheed Martin reported on Thursday.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

With Lockheed Martins donation of the companys corporate aircraft, the National Marrow Donor Program (NMDP)/Be The Match was able to support the federal government's COVID-19 response and relief efforts and ensure patients that life-saving products from European donors would arrive on time.

Under the partnership, Lockheed Martin will provide weekly air transport based on government medical need. The company will fly government medical teams to the most critical, high-priority locations around the country. In addition, Lockheed Martin will transport materials to support bone marrow transport to help with the government's COVID-19 response.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad.

Marillyn Hewson, CEO, chairman and president of Lockheed Martin and 2020 Wash100 Award recipient, recently released the companys efforts to remediate the effects of the global pandemic. In April 2020, Hewson noted that Lockheed Martin has projected that it will be able to flow down over $450 million in accelerated payments to its supply chain partners.

The funding will support those who are critical to supporting the economy and national security. Lockheed will continue its work with the Department of Health and Human Services and provide air transport of government medical teams to the most critical, high-priority locations around the country. The company also pledged $10 million in charitable contributions for COVID-19 relief and recovery efforts.

The company has donated $2 million to Project HOPE to help deliver personal protective equipment to the Federal Emergency Management Agency for distribution to America's doctors, nurses, and first responders. Lockheed also donated $2 million to the American Red Cross to support military personnel, veterans, and families and $2 million to the CDC Foundation All of Us to combat Coronavirus emergency response fund.

As we continue to face this unprecedented crisis, Lockheed Martin is driven by our commitment to the mission of our U.S. and allied customers. We will continue to maintain our operations for our men and women in uniform and we are resolved to find additional ways to contribute to the relief and recovery from COVID-19, Hewson noted.

About Lockheed Martin

Headquartered in Bethesda, Maryland, Lockheed Martin is a global security and aerospace company that employs approximately 110,000 people worldwide and is principally engaged in the research, design, development, manufacture, integration and sustainment of advanced technology systems, products and services.

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PUBLISHED: 06:30 16 May 2020 | UPDATED: 13:58 16 May 2020

James Barham was diagnosed with aggresive leukaemia five weeks after the birth of his son. He has raised more than 18k for the NNUH while undergoing chem at the hospital. Picture: James Barham

James Barham

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On April 2 his first child, Charlie, was born at the Norfolk and Norwich University Hospital (NNUH).

Four weeks later, on Monday May 4, the builder from Drayton got out of bed and blacked out.

The 31-year old went to A&E that day for blood tests and the next day went back to the NNUH for a bone marrow biopsy.

Just 10 minutes after leaving the hospital, he had a call. Mr Barham had an aggressive blood cancer called acute myeloid leukaemia.

We were devastated, Mr Barham said. I was in absolute bits and just couldnt believe it.

Just four days before Charlie was born, Mr Barham said he started feeling nauseous but put it down to nerves ahead of the his sons birth.

It was a long birth and a bit traumatic, he said.

He then started feeling tired but thought it was the stress of having a new baby.

Last Wednesday, the day after he was diagnosed with leukaemia, he was back at the NNUH to start weeks of chemotherapy.

No visitors are allowed because of coronavirus, but staff on Mulbarton ward have moved him to a window bed so he can see his wife Katie and Charlie through the window.

But the new dad has not let the devastating news, or visiting restrictions, get him down.

He launched a charity head shave appeal on Facebook last week to raise funds for the hospitals cancer department and encouraged friends and family to join in.

I thought it would be an opportunity to give back, Mr Barham said.

Im going to be losing my hair anyway and everyone else is in lockdown and not had a haircut for weeks so I thought their friends and family could sponsor them for a head shave too.

Mr Barham lost his locks on Wednesday and has been joined by around 50 other head shavers.

In just over a week he has smashed his target of 6,000.

More than 18,000 has now been donated to the NNUHs charity from 800 people across the world through the Just Giving website. They have had donations from the US, Italy as well as his wifes native Australia.

I wouldve been over the moon if we had raised 2,000, he said. I have got messages from people in the US and India just giving their support.

All donations will go to the NNUHs cancer department, with staff deciding how best they can use it, he said.

The ex-Taverham High School pupil said doctors had told him the cancer was unlikely to be killed by chemotherapy, meaning he will need a stem cell transplant at Addenbrookes Hospital in Cambridge.

Im fit and healthy but this cancer comes up so rapidly and can kill someone. That is what has been the most surprising thing for me, he said.

On his Just Giving fundraising page, he wrote: I have a long journey ahead of me with leukaemia as my new temporary normal.

The constant care and attention Im receiving while Im in hospital is truly exceptional, all from men and women who are overworked and seriously underpaid.

Im now in their hands, so its the least I can do to try and help them back in a small way. Your support will be greatly appreciated. Lets all go forward and be kind to one another.

Louise Cook, head of fundraising at the NNUH, said: We are incredibly grateful for the support and fundraising James, his family and friends are undertaking at this difficult time.

We are overwhelmed at the support shown to the hospital charity, where the money raised will go to support our work with cancer patients. We wish to say thank you to everyone who has got behind James fundraising.

You can donate to Jamess headshave at http://www.justgiving.com/fundraising/james-barham3

A leukaemia which comes with little warning

The NHS says symptoms of acute myeloid leukaemia (AML) can come on suddenly.

They include feeling tired and weak, weight loss and breathlessness.

This blood cancer is caused by a DNA mutation in the stem cells in the bone marrow.

The NHS website says the mutation causes the stem cells to produce many more white blood cells than are needed.

The white blood cells produced are still immature, so they do not have the infection-fighting properties of fully developed white blood cells.

As the number of immature cells increases, the amount of healthy red blood cells decreases and causes the symptoms of leukaemia.

The NHS says it is not know what triggers the genetic mutation.

Patients are treated with chemotherapy or radiotherapy but if that does not work a bone marrow or stem cell transplant may be needed.

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The targeted drug Qinlock, which interferes with the activity of proteins that drive gastrointestinal stromal tumor, has been approved by the Food and Drug Administration for patients with advanced disease that has progressed despite treatment with other kinase inhibitors.

The targeted drug, a kinase inhibitor that interferes with the activity of the cancer-driving proteins KIT and PDGFR, is for adults with GIST who have received prior treatment with three or more kinase inhibitors, including Gleevec (imatinib).

The approval is based on findings from the phase 3 INVICTUS trial, in which the drug led to an 85% reduction in the risk of disease progression or death compared with placebo for the target population.

"Despite the progress that has been made over the past 20 years in developing treatments for GIST, including four FDA-approved targeted therapies imatinib in 2002, sunitinib in 2006, regorafenib in 2013 and avapritinib earlier this year some patients don't respond to treatment and their tumors continues to progress. Today's approval provides a new treatment option for patients who have exhausted all FDA-approved therapies for GIST," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, stated in a press release.

Results showed that the median time until disease progression was 6.3 months with Qinlock compared with 1 month for placebo. At six months, 51% of those on the novel targeted therapy had experienced no disease progression, compared with 3.2% of those taking placebo.

Additionally, there was a 64% reduction in the risk of death with Qinlock compared with placebo. The median overall survival (the length of life from the start of study treatment) was 15.1 versus 6.6 months for Qinlock and placebo, respectively, although that findings statistical significance was not conclusively established. The six-month overall survival rate with Qinlock was 84.3% compared with 55.9% for placebo. The 12-month overall survival rate was 65.4% for Qinlock compared with 25.9% for placebo.

Finally, the objective response rate (the proportion of patients who had a complete or partial response to treatment) with Qinlock was 9.4% compared with no responses in the placebo group. These findings were not statistically significant. The median duration of response had not yet been reached, with seven of eight patients continuing to respond at the time of the data cutoff of May 31, 2019.

Side effects were experienced by 98.8% of patients in the Qinlock arm compared with 97.7% with placebo. Serious or severe side effects that emerged during treatment were experienced by 49.4% of patients in the Qinlock group compared with 44.2% of those taking placebo.

The most common side effects in the Qinlock and placebo groups, respectively, were hair loss (51.8% versus 4.7%), fatigue (42.4% versus 23.3%), nausea (38.8% versus 11.6%), abdominal pain (36.5% versus 30.2%), constipation (34.1% versus 18.6%) and muscle pain (31.8% versis 11.6%). The most common serious or severe grade side effects in the Qinlock versus placebo groups were, respectively, anemia (9.4% versus 14%), high blood pressure (7.1% versus 0%) and abdominal pain (7.1% versus 4.7%).

Check back later for what you need to know about this approval.

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The coronavirus pandemic has caused significant changes and delays to treatment plans for many people battling cancer, who are more susceptible to the virus due to weakened immune systems, nationwide statistics show.

A survey conducted by The American Cancer Society Cancer Action Network in late March and early April found that half of more than 1,000 patients and survivors surveyed had seen their treatment interrupted in some way. Many are working with health care providers to alter their treatment plans skipping treatments, delaying therapies and surgeries, changing dosages and switching to virtual visits to lower their risk of exposure to the virus.

Thesurvey asked respondents about their experience accessing health care as a result of the pandemic, including the availability of appointments and services, and concerns about being able to safely get their treatments in the future. It found that27% of patients in active treatment said they have had their treatment delayed. Of those, 13% saidthey haveno clear timeline for whentreatment will resume.

Additionally, many cancer patients also have had their support systems ripped away, as they practice social isolation and see annual support events such as Relay for Life in southeastern Connecticut canceled.

Balancing risks

Approximately 20,300 people in Connecticut will be diagnosed with cancer in 2020 and 6,390 will die from the disease, according to Bryte Johnson, Connecticut Government Relations Director for American Cancer.

Andy Salner, medical director for the Hartford HealthCare Cancer Institute at Hartford Hospital, said cancer patients often have weakened immune systems, so may more easily contract the virus than someone without cancer. They alsomay developa more severe case ofthe COVID-19, the disease caused by the virus,and have a harder time fighting it.

Some cancers themselves, like multiple melanomas and most types of Leukemia, impact the immune system directly by altering blood cells. People with cancer might also be poorly nourished because cancer itself can make it hard to digest food, cancer cells can use up nutrients and cancer treatments like radiation therapy and chemotherapy can cause nausea and lack of appetite, according to the Cancer Action Network.

Radiation therapy, immunotherapy and chemotherapy also can lead to short-term immune system damage, and bone marrow or stem cell transplants that use high-dose treatments to kill cancer also may harm immune system cells for weeks to months, according to the American Cancer Society. Chemotherapy is the most common cause of a weakened immune system, because it causes a decrease in white blood cells, meaning a person's body won't be able to fight off infections as effectively.

At the Hartford Healthcare Cancer Institute in Waterford, oncologists Michael Kane and Sapna Khubchandani complete thousands of patient visits each year, and are helping patients design new treatment plansto battle and monitor their cancer while reducing their risk of exposure to the coronavirus.

For one local woman, a COVID-19 diagnosis meant missing her final session of chemotherapy, Khubchandani said. She did not identify the patient for privacy reasons.

Khubchandani said she didnt think missing one session so late in the treatment plan would have too much of an impact on the patient, but it wasnt ideal. An elective surgery related to the woman's cancer treatment, meant to take place after she completed chemotherapy, was delayed due to the virus, Khubchandani said.

COVID-19 has caused doctors to delay many suchnonemergency surgeries related to cancer treatment, including breast biopsies, lumpectomies or colonoscopies. Khubchandani, Kane and Salner all said they have had to make changes to surgery plans, either for patient safety or due to a lack of beds in intensive care units that are overwhelmed with patients battling the virus.

Doctors have been exploring alternatives, such as putting patients on hormonal treatment as they await surgery, so that were still treating the cancer while we wait, which will buy them time, Khubchandani said.

From some of his patients, Kane has made adjustments to medication dosages or administration intervals, to limit visits. Its all about individualizing treatment for each patients scenario, he said.

Worrying about the unknown

For one of Kane's patients, Richard van Etten ofHadlyme, protecting the 89-year-old from COVID-19 meant forgoing the transfusion he normally receives every three weeks.

Van Etten has been battling cancer since 2018, first in his bladder, then a cancerous module in his left lung, then in his lymph nodes.

Hecompleted chemotherapy and recently started a new drug called Keytruda, administered via infusions through a port for the cancer in his bladder and lymph nodes.

He recently learned that the cancer in his lymph nodes is gone, but his care team decided to continue his transfusions in case there were any residual cancer cells left, he said. But whenthe coronavirusbecame a concern, they decided to stop.

The virus hit and I was very hesitant about continuing my infusions, which were taking place in Waterford, he said. I talked with Dr. Kane and we decided to forgo them for now.

Since the start of the pandemic, he has been to the treatment center only once, to have his port cleaned. He said he is being very careful and is barely leaving his home, where he lives with his wife and daughter.

Van Etten said that he is absolutely anxious about contracting COVID-19, mostly due to his age. He said he feels confident about his decision to delay his treatment to limit his exposure to the virus but is worried about what might be happening inside his body.

Knowing that I was either in remission or close to it when I stopped, that it was at least temporarily under control, makes me feel OK with missing my infusions, he said. But that doesnt mean that in the back of my mind I dont wonder if it might be coming back.

Heis anxiously awaiting his next in-person visit, a PET scan scheduled for June 1, thats going to tell me whether any of the cancer has come back or not, he said.

Margie Elkins is a breast cancer survivor and active volunteer for the American Cancer Society and several other cancer organizations in southeastern Connecticut. While she is missing regular checkups and experiencing some delays in her own follow-up care, she said, One of the things that really worries me is not only the people who are experiencing delays in treatment but the people who have yet to be diagnosed, because the longer you wait in some cases, the larger the cancer becomes."

For thosewhose treatment hasbeen delayed, Its like their life is on hold because they dont know if their cancer is getting worse or getting better, she said.

Salner said delaying treatments certainly poses a risk. I think the worry would be that the cancer cells could potentially grow during that time (that treatments are delayed), that the treatment might be less effective if its delayed too far, he said.

Among survey respondents whose care had been canceled, delayed or changed by the pandemic, the most commonly impacted services were imaging procedures to monitor growth of cancer, supportive services such as therapy and in-person provider visits.

Salner said that decisions to delay chemotherapies and radiation, or reversing the order of treatments to prevent weakening of the immune system during the pandemic, were being made regularly and in partnership with patients and their families.

We want to balance making sure that we deliver the best cancer therapy possible but also place the patient at the lowest risk for getting what could be a life-threatening infection, he said.

In Waterford, Kane and Khubchandani have started screening patients for COVID-19 before starting them on chemotherapy or immunotherapy to ensure they are strong and healthy enough for the treatment. If a patient does have the virus, the doctors are delaying chemotherapy or immunotherapy in almost all cases. The ultimate decision though, is primarily left up to the patient. If they want to receive treatment, they likely will be able to, doctors agree.

Kane and Khubchandani also are implementing general precautions for people entering their offices: taking patients temperature, calling patients the day before to screen for COVID-19 symptoms and opting for virtual visits when possible. At the Waterford treatment center, theyve reduced the number of chairs in the waiting room and are scheduling laboratory services further apart. All doctors and patients are wearing masks at all times.

The extra precautions seem to be helping, Salner said. The Hartford Healthcare group has not seen a large influx of cancer patients testing positive for COVID-19.

Finding support

Some survivors are concerned about the emotional impact of COVID-19 on people currently battling cancer, worrying that they may feel overwhelmed and alone, both in their diagnosis and by social distancing.

Elkins said that she felt isolated when she was first diagnosed with stage1 breast cancer years ago, and can only imagine how that feeling is being compounded by the isolation of quarantine.

Greg Schlough, event chairman for the American Cancer Society Relay for Life of Southeastern CT, said that in his experience, cancer is a disease that causes people to really rally around you. The survivor saidthose with cancer tend to rely on their family and friends for support, like he did after being diagnosed with stage 3 melanoma on his 40th birthday in September 2000.

At the beginning, you get that doom and gloom feeling but when people start to come around and you start to see other people who have survived, you are able to say Hey, Im going to beat this thing. You know that you have people backing up and cheering you on, he said.

Right now, folks fighting cancer, especially a new diagnosis, may be struggling to find that support as they practice social distancing from their family and friends.

Schlough, in remission for 20 years, said that if he was a cancer patient right now, he would be afraid to go outside, and cant imagine how new patients are feeling.

For patients who are struggling with feelings of isolation or fear, events like the annual relay provide an opportunity to connect with others who are fighting the same fight, or who are examples of strength and survival. This years relay, which was set to be held on July 14 in Norwich, has been postponed indefinitely.

The annual fundraiser normally raises an average of $80,000 to $120,000 a year for the American Cancer Society, helping the society fund resources and support services to help people with cancer.

Schlough said organizers are hoping to reschedule the event for the end of summer, but it wouldfunction in accordance with social distancing guidelines and everyone will be required to wear masks. People currently in treatment, he said, may have to miss out or participate virtually.

Wed rather see them there next year smiling than this year with the risk of getting sick, he said.

Schloughsuggests patients or survivors who are emotionally strugglingor needhelp understanding treatment options shouldreach out to friends and family for over-the-phone support or call the American Cancer Societys hotline, 1 (800) 227-2345.

t.hartz@theday.com

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Technology across the world is improving and innovatingwith time. Over the years, man-managed labor has almost finished from themarket and more and more technological and scientific gadgets are taking placemaking human labor more effective, efficient, and precise.

Medical science has also taken a lot of advantage fromthis scientific advancement therefore, we can say that doctors are making fulluse of science and technology and the world of medicine has evolved quiterapidly.

Orthopedic hospitalshave also seena remarkable transformation over time and the days when a regular orthopedicclinic only comprised of a few tools and a bad. The launch of innovativetechnologies, biologics, and hybrid items into the orthopedic industry isincreasingly growing.

Any of these emerging inventions gain regulatory approvalby showing significant equivalence to the US System of the Food and DrugAdministration (FDA) 510(k).

Surgeons play a key role in the implementation ofemerging technology to patients and will play a leading role in supportinghealthy, efficient, adequate, and cost-effective treatment, particularly forsurgical procedures. Surgeons will track and record the health results andadverse effects of their patients utilizing modern technologies and ensure thatthe new technology works as expected.

Ortho-biologics utilizes the regenerative ability ofcells in the human body. Ortho-biologics are created from compounds naturallypresent in the body which are used to facilitate the recovery of fracturedbones which injured joints, ligaments, and tendons.

These involve bone graft, growth factors, stem cells,platelet-infused plasma, autologous blood, and autologous controlled serum. Themesenchymal stem cells (MSCs) contained in the bone marrow has been shown to besuccessful in the production of the appropriate tissues.

Result in Orthopedic Procedures

Recent advances in this area, including growth factor andstem cell therapies, may contribute to faster recovery. One breakthrough isdrug-free bone grafts, which may be used to cure conditions such as orthopedicsurgery. Clinical trials have demonstrated that growth factors can improve thehealing cycle.

Stem cells will continually self-regenerate and transforminto either form of cell, providing an unmatched source of regenerativemedicine technology. Definitions of musculoskeletal procedures utilizing stemcells are listed below.

Biotechnology firms began utilizing orthopedic stemcells. For starters, BioTime works on stem cell therapies for age-relateddegenerative diseases, IntelliCell BioSciences on adipose-derived stem cellsfor orthopedic conditions, and Bio-Tissues on Ortho-biological treatments forcartilage defects.

Orthopedic procedures using robots are less intrusive anddeliver reproducible accuracy, resulting in shorter hospital stays and quickerrecovery times. The Swiss clinic, La Source, recorded a decline in averagehospitalization from 10 to 6 days with the usage of surgical robots.Nevertheless, this technology is also costly to develop, so solid,evidence-based trials are required to prove that robotic technology contributesto improved outcomes.

The Da Vinci Surgical Method became the first U.S. Food andDrug Administration (FDA)-an authorized robotic surgery program in 2000. Morebusinesses are investing in this technology to enhance navigation duringservice or to receive 3-D scans that aid in the design of custom joints.

Organizations that are interested, in robotics areinclined towards the following technological masterpieces:

Several modern surgical techniques are enhancing theresults. These involve motion-preservation methods, minimally intrusive surgery,tissue-guided surgery, and cement-free joint repair.

Motion recovery strategies require partial or completedisk removal and the usage of active stability systems and interspinous spacersthat do not impair versatility.

Minimally intrusive procedures involve the use ofendoscopes, tubular retractors, and computer-aided guidance devices, allowingan incision of just 2 cm instead of 12 cm in conventional therapies. Minimallyinvasive treatments are gaining popularity in joint and hip replacement and spinalsurgery.

Smart devices provide built-in sensors to offer real-timetracking and post-operative evaluation details to surgeons for better patientsafety across the clinical process. Such implants have the ability to minimizeperiprosthetic infection, which is an increasing orthopedic issue.Sensor-enabled innovations also presented health care professionals with arange of innovative, cost-effective goods.

Companies working in this field include:

3-D orthopedic printing is gaining traction in themanufacture of personalized braces, surgical equipment, and orthotics from arange of materials. 3-D printing technology cuts operating times, saves energy,increases the long-term reliability of the implant, and enhances the healtheffects of surgical procedures. 3-D printing technologies of orthopedics areinclusive of:

Companies investing in 3-D Orthopedic Printing

Medical science has taken a huge turn with the introduction of technology. The orthopedic industry has also transformed to a huge extent making sure that the specialists and surgeons are able to treat and operate on their patients without any hassle. Almost all the orthopedic hospitals are equipped with high-end gadgets and tools to assist the doctor.

Even though the technology has evolved greatly since thefield of medicine was invented, it is important to understand that this is justa beginning and there are many more things to come in the future.

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VANCOUVER, Washington, May 15, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it is offering comprehensive cytokine profiling (including RANTES levels) through its diagnostic partner company, IncellDx, to help physicians understand the pathogenesis of Childhood Inflammatory Disease Related to COVID-19. These laboratory tests are exploratory in nature and not intended for clinical decision making.

Recent reports in parts of the U.S. and Europe suggest a rare and potentially fatal inflammatory disease linked to the novel coronavirus is afflicting a small number of children. The condition resembles a rare childhood illness called Kawasaki disease, which has similar signs and symptoms and can lead to enlargement of blood vessels that in severe forms may cause heart damage.

New York State Department of Health is investigating 110 reported cases and 3 deaths in children - predominantly school-aged - experiencing symptoms similar to Kawasaki disease and toxic shock-like syndrome, possibly due to COVID-19.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn commented, Cytokines are proteins that modulate the inflammatory response. Kawasaki disease has been previously shown to be associated with elevated levels of RANTES, a protein we have shown to be significantly elevated in mild-moderate COVID-19 and over 100 times normal in critical COVID-19 patients.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn added, We hope our comprehensive cytokine testing will help physicians gain a better understanding of the disease process and, in turn, explore the prospect for leronlimab to potentially provide a therapeutic benefit to children suffering from inflammatory illness related to COVID-19.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination Therapy The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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CytoDyn to Offer No-Cost Exploratory Laboratory Testing for Childhood Inflammatory Disease Associated with COVID-19 - The Bakersfield Californian

Bone Marrow Stem Cells Comments Off on CytoDyn to Offer No-Cost Exploratory Laboratory Testing for Childhood Inflammatory Disease Associated with COVID-19 – The Bakersfield Californian | May 16th, 2020

Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals, said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Womens Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the companys progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the companys continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, responseadapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - BioSpace

Cardiac Stem Cells Comments Off on Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting – BioSpace | May 15th, 2020

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics , Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the first quarter ended March 31, 2020.

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. On April 1, 2020 AgeX drew the initial $500,000, and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

468

$

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

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AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Business Wire

IPS Cell Therapy Comments Off on AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Business Wire | May 15th, 2020

American Cancer Society: Bone Marrow and Peripheral Blood Stem Cell Transplants - The American Cancer Society is the nationwide community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and service. Learn the basics and read the transplant process at this site.

The Bone Marrow Foundation - The mission of The Bone Marrow Foundation is to improve the quality of life for bone marrow and stem cell transplant patients and their families by providing financial aid, education and emotional support.

BMT InfoNet - Blood & Marrow Transplant Information Network is a not-for-profit organization dedicated exclusively to serving the needs of persons facing a bone marrow, blood stem cell or umbilical cord blood transplant. Here you will find support services, a drug database and more.

Cancer.Net: Understanding Bone Marrow and Stem Cell Transplantation - This is the patient information Web site of the American Society of Clinical Oncology (ASCO).

Gift of Life - Gift of Life is an international public bone marrow and blood stem cell registry. Information will be found at this site for both donors and patients.

Macmillan Cancer Support: Stem Cell and Bone Marrow Transplants - This UK based organization helps with all the things that people affected by cancer want and need. The basics on transplants and their side effects can be found here.

MedlinePlus: Bone Marrow Transplantation - Developed by the National Library of Medicine, this consumer health site directs the user to selected online resources on many common diseases, conditions, and concerns.Also in Spanish.

MedlinePlus: Stem Cells - Developed by the National Library of Medicine, this consumer health site directs the user to selected online resources on many common diseases, conditions, and concerns.Also in Spanish.

National Bone Marrow Transplant Link (nbmtLINK) - The mission of the nbmtLINK is to help patients, as well as their caregivers, families and the health care community meet the many challenges of stem cell transplant by providing vital information and support services.

National Cancer Institute: Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation -The NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training. This informative fact sheet is in question and answer format.

National Cancer Institute: Dictionary of Cancer Terms, Stem Cell transplant - The NCI, established under the National Cancer Act of 1937, is the Federal Government's principal agency for cancer research and training. This link provides basic information on what a stem cell transplant is and provides several images to aid understanding of the process.

National Marrow Donor Program - This resource (Be The Match) provides a wealth of information for both patients and donors.Click here for translated materials on marrow donation.

Interactive Tutorials / Videos

Mayo Clinic - Bone Marrow Transplants - This video offers general information on bone marrow transplantation.

The New Normal - An Emmy-award winning film in eight parts. Features survivors stories and the transplant process.

November 2018

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Bone Marrow/Stem Cell Transplants | Rutgers Cancer ...

Bone Marrow Stem Cells Comments Off on Bone Marrow/Stem Cell Transplants | Rutgers Cancer … | May 15th, 2020

A rapid-acting bone marrow transplant developed by the Israeli biotech Gamida Cell was engrafted in blood cancer patients 10 days faster than standard umbilical cord blood transplants in a phase III trial.

The trial recruited 125 blood cancer patients in more than 50 clinical centers globally. One group received a standard transplant of donor umbilical cord blood cells and another group received Gamidas treatment omidubicel, which consists of umbilical cord blood cells that are expanded and cultured in the lab.

According to the trial results, omidubicel established itself in the patients and started making healthy new immune cells after around 12 days, measured by counting cells called neutrophils in the blood. This was significantly faster than the 22 days it took in patients given a regular umbilical cord blood transplant.

Blood cancer patients often receive stem cell transplants to replace bone marrow cells that are damaged by chemotherapy or radiation therapy. Donor stem cell transplants can come from adult bone marrow cells, stem cells in the blood, or umbilical cord blood stem cells.

A common problem with bone marrow transplants is compatibility, where the donors cells could fail to engraft or even attack the recipient if the cell types dont match properly. This problem is less common in umbilical cord blood transplants than other sources, but this type of transplant also provides a lower dose of stem cells, which can delay the engraftment process.

To solve this issue, Gamida Cells treatment is designed to take donor umbilical cord cells and boost their stem cell count in the lab prior to administering the treatment to patients.

These results have the potential to substantially move the field forward and represent an important step toward making stem cell transplantation more accessible and more successful for patients with lethal blood cancers, stated Mitchell Horwitz, Principal Investigator and Professor of Medicine at the Duke Cancer Institute, USA.

Shortening the time to engraftment is clinically meaningful, as it can reduce a patients time in the hospital and decrease the likelihood of infection.

The company aims to apply for FDA approval in late 2020, with a potential commercial launch in 2021. According to a conference call today, Gamida Cell had completed its phase III enrollment in December. This meant that the trial was luckily unaffected by the onset of the Covid-19 pandemic, which has delayed clinical trials for many companies worldwide.

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MINNEAPOLIS, May 14, 2020 /PRNewswire/ --The challenges surrounding COVID-19 have impacted every aspect of healthcare, including ensuring the timely delivery of bone marrow and blood stem cells for transplant. Thanks to the generosity of the Lockheed Martin Corporation, however, patients are able to continue receiving life-saving transplants without interruption.

When the National Marrow Donor Program (NMDP)/Be The Match ran out of available European Union couriers to deliver life-saving cells to American patients and with tens of thousands of commercial flights canceled, Lockheed Martin stepped up to offer their corporate aircraft as an in-kind donation to support the federal government's COVID-19 response and relief efforts to ensure patients that life-saving products from European donors would arrive on time.

NMDP/Be The Match, operates the federally authorized program that matches unrelated volunteer donors with patients in the United States and abroad who have been diagnosed with leukemia and over 70 more otherwise fatal blood disorders and diseases.

In addition to matching donors and patients, one of the program's primary missions is coordinating the delivery of bone marrow domestically and internationally to patients in the United States and abroad. This life-or-death delivery has historically been accomplished by trained couriers hand carrying donated marrow in the passenger compartment of commercial aircraft from donor collection centers to the hospitals of patients all across the globe.

Patients who are scheduled to receive transplants in the coming days are already in the process of a carefully timed course of chemotherapy and radiation treatments designed to eliminate their existing immune systems in preparation for the transplantation of cells to create a healthy, new immune system. If the transportation of donor cells is interrupted, the consequences are fatal to these patients whose immune systems have been ablated.

"The incredible support from Lockheed Martin is a lifeline to our patients. For those awaiting bone marrow transplant, their very survival depends on the on-time delivery of these life-saving cells. By offering flight services, Lockheed Martin is helping us ensure that patients can continue the cells they need, exactly when they need them," said NMDP/Be The Match Chief Policy Officer Brian Lindberg.

As part of this partnership Lockheed Martin will be providing weekly air transport based on government medical need flying government medical teams to the most critical, high-priority locations around the country and/or flying to support bone marrow transport to help with the government's COVID-19 response.

NMDP/Be The Match has facilitated over 100,000 bone marrow transplants since 1987 to deliver cures for patients battling blood cancers and blood disorders. More than 50 percent of those transplants involve international donors or recipients.

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Scientists have made embryosthat are a lot mouse and a little bit human.

With a little help, human stem cells can knit themselves into growingmouse embryos, populating thedeveloping liver, heart, retina and blood, researchers report May 13 in Science Advances.

Finicky human cells dont tend to grow well in other animals. But in one of the new mouse embryos, 4 percent of its cells were human the most thorough mixing between human and mouse yet.

That level of integration isquite striking to me, says Juan Carlos Izpisua Belmonte, a stem cell anddevelopmental biologist at the Salk Institute for Biological Studies in LaJolla, Calif. If other scientists can replicate the findings, it potentiallyrepresents a major advance, says Izpisua Belmonte, who was not involved in thestudy.

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Such chimeras could helpreveal how a single cell can give rise to an entire organism. More humanizedanimals could also prove valuable in studying diseases such as malaria that affectpeople more than other animals. And with more advances, chimeras couldultimately turn out to be a source of human organs.

Many scientists have hitroadblocks in growing human stem cells in mice or other animals, including pigs and cows(SN: 1/26/17). We have analyzedthousands of embryos but never saw robust chimeric contribution of human stemcells to mouse embryos beyond day 12, says stem cell and developmentalbiologist Jun Wu of the University of Texas Southwestern Medical Center inDallas, who wasnt involved in the study.

The new methods success comes down to timing, says neuroscientist and stem cell biologist Jian Feng. To grow and thrive in a mouse embryo, human stem cells developmental clocks must be turned back to an earlier phase called the nave stage. You need to basically push the human cells back to that phase, says Feng, of the University at Buffalo in New York.

Feng and his colleagues resetthe stem cells clocks by silencing a protein called mTOR for three hours. Thisbrief treatment shocked the cells back to their nave stage, presumably restoringtheir ability to turn into any cell in the body.

Researchers injected batchesof 10 to 12 of these more youthful human stem cells into mouse embryos containingabout 60 to 80 mouse cells, and allowed the embryos to develop for 17 days.

To outward appearances, these embryos grew normally despite harboring human cells. By tallying DNA that was specific to either mouse or human, the researchers found that human cells accounted for between 0.1 and 4 percent of the total cells in the embryos.

Human cells knittedthemselves into most developing tissues of the mouse, destined to become theliver, heart, bone marrow and blood. Human red blood cells were particularlyabundant in these mouse embryos, the researchers found. A small number of humancells showed up in tissue that will form a brain; one embryo had a swarm of humanphotoreceptors, eye cells that help detect light.

As far as the researcherscould tell, no human cells were among the cells that go on to form sperm andegg. The capacity of chimeras to reproduce is one of the worrisome ethicalquestions surrounding the organisms that scientists are still trying to figureout.

Once inside a mouse embryo, the normally sluggish developmental pace of the human cells sped up to match their hosts. Human stem cells typically are slow to turn into certain types of mature photoreceptors, liver cells or red blood cells, Feng says, but not when the human cells are inside a mouse embryo. You put the same human cells in a mouse embryo, [and] they go fast, Feng says. In 17 days, you get all these mature cells that would otherwise take months to get in a normal human embryo.

Other scientists emphasize that different laboratories need to repeat the results. But if it works a big if here this has big implications, Wu says.

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PERTH, Australia Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).

The Melbourne-headquartered company is currently enrolling patients in a randomized placebo-controlled phase II/III trial in up to 300 patients across 30 sites in the U.S. The trial is evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate to severe ARDS.

Patients are being dosed, and were really pleased how fast enrollment is growing, Mesoblast CEO Silviu Itescu told BioWorld. Were right on target and hope to update the market soon.

The phase II/III trial was initiated after promising results were seen with remestemcel-L under an emergency compassionate-use protocol in COVID-19 ARDS at Mount Sinai Hospital in New York, where nine of 12 (75%) ventilator-dependent patients were able to come off ventilators within 10 days.

Under the compassionate-use protocol, patients in intensive care units received standard-of-care treatment. Once they were intubated on a ventilator, they were treated within 72 hours with two infusions of Mesoblasts remestemcel-L cells within five days.

Once youre ventilated when you have acute respiratory distress syndrome in the lungs, your likelihood of coming off a ventilator is 9%, and your survival is 12%, Itescu said.

Whats exciting is that our patients in the same epicenter of this disease with the same treatment everyone else is getting, suddenly 75% are coming off of ventilators within 10 days, and weve got 83% survival, Itescu said.

The compassionate-use treatment experience informed the design of the phase II/III trial, and the FDA approved the same protocol, but it is powered so that results will be self-evident, Itescu said.

The phase II/III trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo on top of standard of care, in line with guidance provided by the FDA. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, he said.

Capital raise allows scale up for COVID-19 and influenza

The capital raise consisted of a placement of 43 million shares to existing and new institutional investors at a price of AU$3.20 per share, representing a 7% discount to the five-day volume-weighted average price (VWAP) at the close of trading May 8. The placement was conducted with Bell Potter Securities as lead manager and underwriter. Settlement is expected to occur on Friday, May 15.

Most of the funds raised will be used to scale up manufacturing of remestemcel-L for the treatment of critically ill patients suffering with diseases causing ARDS, including COVID-19 and influenza.

Were in the middle of a pandemic, and people are talking about opening up, and theyre talking about a potential second wave, Itescu said. Its too early to talk about projections, but we need to at least be in a position to make more product in an additional facility, so that requires technology transfer and certain process improvements.

Remestemcel-L is Mesoblasts lead product, and it is currently being studied in multiple indications so the move to ramp up manufacturing is a good strategic move regardless of COVID-19, he said.

There are at least 125,000 patients every year in the United States with influenza-related acute respiratory distress syndrome in intensive care units, and those patients have got about a 40% fatality rate. Up to about 60,000 patients die per year due to influenza ARDS, so even if COVID-19 magically disappears, which we could only hope, influenza is here to stay despite vaccines being available, the CEO said.

This product would work in the same way for influenza-related ARDS as it would for COVID-19-related ARDS, he said.

The ability to build out manufacturing capacity is part of an FDA requirement to be able to demonstrate it can make product for patients in the U.S.

The company already has a manufacturing facility in Singapore, and the additional site in the U.S. would give the company the ability to provide product globally.

Were putting our strategic plan into play. You need to have multiple geographies, especially in this kind of environment, Itescu said.

Without the cash, we wouldnt have been able to deliver on this, but we now can execute.

Mesoblast's allogeneic candidates are based on mesenchymal lineage cells collected from the bone marrow of healthy adult donors.

Remestemcel-L is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil.

The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD.

Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing phase III trials in advanced heart failure and chronic low back pain.

Mesoblast shares (ASX:MSB) were down 1.45% on the news, trading at AU$3.39 per share by market close May 13. On Nasdaq (MESO), shares closed at $12.15.

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SALT LAKE CITY, Utah, May 14, 2020 /PRNewswire/ --Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced that the first patient has been dosed with a one-hour dosing schedule for investigational agent alvocidib, a potent CDK9 inhibitor, administered in sequence after azacitidine, in the expansion of the Phase 1b/2 Zella 102 study in patients with myelodysplastic syndromes (MDS).

The Zella 102 study is being conducted in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with a hypomethylating agent. The initial study design was to evaluate the safety and efficacy of alvocidib using a 30-minute bolus followed by a four-hour intravenous infusion (IVI), in combination with decitabine. An amendment was made to the study design to include treatment with azacitidine, in sequence before a one-hour infusion of alvocidib.

"We are pleased that this study now includes both standard of care hypomethylating agents for patients with myelodysplastic syndromes. In addition, the expansion of this study offers an alternative alvocidib dosing schedule, which reduces the amount of time patients spend in infusion," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "Preclinical research suggests that treatment with hypomethylating agents may sensitize MDS blast cells to suppression of MCL-1 through alvocidib. We look forward to building our understanding of the potential role of alvocidib in this patient population."

MDS is a form of cancer that can occur when cells in the bone marrow are abnormal and create defective blood cells, which often die earlier than normal cells. In one of three patients, MDS can progress into AML, a rapidly growing cancer of bone marrow cells.1

About the Zella 102 Study

The Zella 102 study is an open-label, dose-escalation Phase 1b/2 study evaluating the safety and efficacy of alvocidib, when administered in sequence after eitherdecitabine or azacitidine, in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with hypomethylating agents. The primary objective of the Phase 1b portion of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of alvocidib, when administered in these regimens. Secondary objectives are to determinethe complete response rate and if treatment with alvocidib, administered in sequence after decitabine or azacitidine,results in improvements in transfusion dependence and/or hemoglobin level.

The primary objective of the Phase 2 portion of the study will be to determine the objective response rate of alvocidib, when administered to untreated patients with de novo or secondary MDS in sequence after a hypomethylating agent, using revised International Working Group (IWG) criteria.

The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at http://www.ClinicalTrials.gov (NCT03593915).

About Alvocidib

Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in the Phase 2 studies Zella 202, in patients with acute myeloid leukemia (AML) who have either relapsed from or are refractory to venetoclax in combination with decitabineor azacitidine(NCT03969420)and Zella 201, in patients with relapsed or refractory MCL-1 dependent AML, in combination with cytarabine and mitoxantrone(NCT02520011). Alvocidib is also being evaluated in Zella 101, a Phase 1 clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with cytarabine and daunorubicin (7+3) in newly diagnosed patients with AML(NCT03298984), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with decitabine or azacitidine(NCT03593915). In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax(NCT03441555).

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2

About Tolero Pharmaceuticals, Inc.

Tolero Pharmaceuticals is a clinical-stage biopharmaceutical company researching and developing treatments to improve and extend the lives of patients with hematological and oncological diseases. Tolero has a diverse pipeline that targets important biological drivers of blood disorders to treat leukemias, anemia, and solid tumors, as well as targets of drug resistance and transcriptional control.

Tolero Pharmaceuticals is based in the United States and is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Tolero works closely with its parent company, Sumitomo Dainippon Pharma, and Boston Biomedical, Inc., also a wholly owned subsidiary, to advance a pipeline of innovative oncology treatments. The organizations apply their expertise and collaborate to achieve a common objective - expediting the discovery, development and commercialization of novel treatment options.

Additional information about the company and its product pipeline can be found atwww.toleropharma.com.

Tolero Pharmaceuticals Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties, which could cause actual outcomes to differ materially from current expectations. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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DetailsCategory: DNA RNA and CellsPublished on Thursday, 14 May 2020 10:13Hits: 234

CAMBRIDGE, MA, USA I May 12, 2020 I Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology bothin vivoandex vivo,is presenting three oral presentations and two poster presentations at the 23rd Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), taking place virtually from May 12-15, 2020. Intellia researchers are presenting new data in support of NTLA-5001, the companys engineered cell therapy candidate for the treatment of acute myeloid leukemia (AML). Intellia is also providing an update on NTLA-2002, its newest development candidate for the treatment of hereditary angioedema (HAE).

At Intellia, we are applying our CRISPR/Cas9 technology to develop new processes that can produce enhanced engineered cell therapies to treat severe cancers, such as AML, that traditional approaches cannot address. Our proprietary platform provides a powerful tool to generate more potent TCR-directed cells, that can treat blood cancers initially and potentially solid tumors. The data being presented today validate Intellias approach of reducing AML tumor cell blasts, and our plans to enter the clinic with NTLA-5001 next year, said Intellia President and CEO John Leonard, M.D. We are also pleased to present data that support our recently announced HAE development candidate, NTLA-2002, Intellias second systemic therapy employing our in vivo knockout approach and modular delivery platform.

Data Presentations on Intellias First Engineered Cell Therapy Development Candidate, NTLA-5001 for the Treatment of AML, and Proprietary Cell Engineering Process

NTLA-5001 is Intellias first engineered T cell receptor (TCR) T cell therapy development candidate, which targets the Wilms Tumor 1 (WT1) intracellular antigen for the treatment of AML. NTLA-5001 is being developed in collaboration with Chiara Boninis team at IRCCS Ospedale San Raffaele to treat AML patients regardless of the genetic subtype of a patients leukemia. AML is a cancer of the blood and bone marrow that is rapidly fatal without immediate treatment and is the most common type of acute leukemia in adults(Source:NIH SEER Cancer Stat Facts: Leukemia AML).

Intellias proprietary process is a significant improvement over standard engineering processes commonly used to introduce nucleic acids into cells. Intellias process enabled multiple gene edits using CRISPR/Cas9, while maintaining cell products with high expansion potential and minimal undesirable chromosomal translocations. CRISPR/Cas9 was used to insert a WT1-directed TCR in locus, while eliminating the expression of the endogenous TCRs, with the goal of producing homogeneous T cell therapies like NTLA-5001.

Intellias novel approach with NTLA-5001 can overcome the challenges of standard T cell therapy, including risks of reduced specificity associated with mixed expression and mispairing of endogenous and transgenic TCRs (tgTCRs); graph-versus-host disease (GvHD) risks, which could lead to an attack on the patients healthy cells; and reduced efficacy tied to lower tgTCR expression per T cell. Intellias unprecedented process is expected to streamline cell engineering and manufacturing, yielding a homogenous product comprising WT1-targeted T cells with high anti-tumor activity. Data highlights from todays presentation include the following:

Intellias cell engineering efforts are focused on its initial clinical investigation of NLTA-5001 on AML, while continuing preclinical studies exploring the potential for targeting WT1 in solid tumors. The company confirmed plans last week to submit an IND or IND-equivalent for NTLA-5001 for the treatment of AML in the first half of 2021.

The presentation titled, Enhanced tgTCR T Cell Product Attributes Through Process Improvement of CRISPR/Cas9 Engineering, will be made today by Aaron Prodeus, Ph.D., senior scientist, Cell Therapy, and can be found here, on the Scientific Publications & Presentations page of Intellias website. These data were a follow-on to the study presented at Keystone Symposias Engineering the Genome Conference from this past February.

In Vivo Data Supports Intellias Novel TCR Candidate

A second presentation on engineered cell therapy progress, in collaboration with IRCCS Ospedale San Raffaele, showed in vivo data demonstrating the potential of TCR-edited T cells to effectively target WT1 tumor cells in AML. In addition to the previously disclosed results of effective in vitro recognition of primary AML tumor cells by edited WT1-specific cytotoxic T cells (CD8 T cells), new data indicate that the selected TCR also enables T helper cells (CD4 T cells) to react to WT1-expressing tumor cells, providing cytokine support. This distinguishes Intellias TCR from other therapeutic TCR candidates, which either exclusively activate toxic CD8 T cells or require the co-transfection of CD8 into CD4 T cells to render them functional.

Using a mouse model carrying disseminated human primary AML, researchers observed a significant therapeutic effect, including decreased AML tumor burden. In addition, no signs of GvHD were observed in mice treated with the WT1-specific T cells. The data show that tgTCR-engineered cells have targeted anti-cancer activity in a challenging model of systemic AML, demonstrating the therapeutic potential of Intellias engineered TCR T cell approach.

The presentation titled, Exploiting CRISPR-Genome Editing and WT1-Specific T Cell Receptors to Redirect T Lymphocytes Against Acute Myeloid Leukemia, will be given today by Eliana Ruggiero, Ph.D., Experimental Hematology Unit, Division of Immunology, Transplantation and Infectious Diseases, IRCCS Ospedale San Raffaele, Italy. Notably, ASGCT meeting organizers selected this presentation as one of six to receive the ASGCT Excellence in Research Award this year.

Continued Progress on Intellias Second In Vivo Development Candidate, NTLA-2002 for the Treatment of HAE

Intellia is presenting development data updates on its potential HAE therapy, NTLA-2002, which utilizes the companys systemic in vivo knockout approach, including its proprietary lipid nanoparticle (LNP) system. HAE is a rare genetic disorder characterized by recurring and unpredictable severe swelling attacks in various parts of the body, and is significantly debilitating or even fatal in certain cases. NTLA-2002 aims to prevent unregulated production of bradykinin by knocking out the prekallikrein B1 (KLKB1) gene through a single course of treatment to ameliorate the frequency and intensity of these swelling attacks.

The KLKB1 gene knockout in an ongoing non-human primate (NHP) study resulted in a sustained 90% reduction in kallikrein activity, a level that translates to a therapeutically meaningful impact on HAE attack rates(Source: Banerji et al., NEJM, 2017). This kallikrein activity reduction was sustained for at least six months, demonstrating the same high level of efficacy and durability seen in earlier rodent studies.

The short talk titled, CRISPR/Cas9-Mediated Gene Knockout of KLKB1 to Treat Hereditary Angioedema, will be given by Jessica Seitzer, director, Genomics, Intellia on Fri., May 15, 2020, when it will be made available here, on the Scientific Publications & Presentations page of Intellias website. The presented data include results from ongoing collaborations with researchers at Regeneron, and the program is subject to an option by Regeneron to enter into a Co/Co agreement, in which Intellia would remain the lead party. Intellia expects to submit an IND or IND-equivalent to initiate a Phase 1 trial for NTLA-2002 in the second half of 2021.

About Intellia Therapeutics

Intellia Therapeuticsis a leading genome editing company focused on developing proprietary, curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course, and through improved cell therapies that can treat cancer and immunological diseases, or can replace patients diseased cells. The combination of deep scientific, technical and clinical development experience, along with its leading intellectual property portfolio, puts Intellia in a unique position to unlock broad therapeutic applications of the CRISPR/Cas9 technology and create a new class of therapeutic products. Learn more aboutIntellia Therapeuticsand CRISPR/Cas9 atintelliatx.comand follow us on Twitter @intelliatweets.

SOURCE: Intellia Therapeutics

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