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Research and therapy with induced pluripotent stem cells ...

IPS Cell Therapy Comments Off on Research and therapy with induced pluripotent stem cells … | July 8th, 2020

Hitachi, Ltd and ThinkCyte, Inc. announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

Founded in 2016 and headquartered in Tokyo, Japan, ThinkCyte, is a biotechnology company that develops life science research, diagnostics, and treatments using integrated multidisciplinary technologies. It has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. ThinkCyte has developed the Ghost Cytometry technology to achieve high-throughput and high-content single cell sorting and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products.

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Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory - ARC Viewpoints

IPS Cell Therapy Comments Off on Hitachi and ThinkCyte to Develop an AI-driven Cell Analysis | ARC Advisory – ARC Viewpoints | July 6th, 2020

TOKYO, July 1, 2020 /PRNewswire/ --Hitachi, Ltd.(TSE: 6501, "Hitachi") and ThinkCyte, Inc. ("ThinkCyte") today announced that they have entered into a collaboration focused on developing an artificial intelligence (AI)-driven cell analysis and sorting system. Hitachi provides a broad range of solutions such as automated cell culture technologies to pharmaceutical companies in the value chain*1 of the regenerative medicine and cell therapy industry. Through the addition of this cell analysis and sorting system to the value chain, Hitachi continues contributing to cost reductions in the manufacturing of regenerative medicine and cell therapy products.Further, Hitachi and ThinkCyte are promoting collaboration with pharmaceutical companies and research institutes working in the field of regenerative medicine and cell therapy to expedite the development of the system toward commercialization.

The practical applications of regenerative medicine and cell therapy using cells for treatment have been expanding rapidly with the first regulatory approval of CAR-T*2 therapy for leukemia in 2017 in the United States and 2019 in Japan. The global market for regenerative medicine and cell therapy is expected to grow from US$ 5.9 billion (JPY 630 billion) in 2020 to US$ 35.4 billion (JPY 3.8 trillion) in 2025*3. In order to scale up treatment using regenerative medicine and cell therapy products, it is critical to ensure consistent selection and stable supply of high quality cells in large quantities and at a low costs.

Hitachi has been providing large-scale automated induced pluripotent stem (iPS) cell culture equipment, cell processing facilities (CPFs), manufacturing execution systems(MES), and biosafety cabinets among other products to pharmaceutical companies and research institutes, and has developed a value chain to meet a variety of customer needs in the regenerative medicine and cell therapy industry. Hitachi has also been carrying out collaborative research projects with universities, research institutes, and other companies to develop core technologies for pharmaceutical manufacturing instruments and in vitro diagnostic medical devices, prototyping for mass production, and working on manufacturing cost reduction and the development of stable and reliable instruments.

ThinkCyte has been performing research and development focused on high-throughput single cell analysis and sorting technology to precisely analyze and isolate target cells. While such single cell analysis and sorting technologies are vital to life science and medical research, it has been thought impossible to achieve high-throughput cell sorting based on high-content image information of every single cell. ThinkCyte has developed the world's first Ghost Cytometrytechnology to achieve high-throughput and high-content single cell sorting*4and has been conducting collaborative research projects with multiple pharmaceutical companies and research institutes to utilize this technology in life science and medical fields.

Hitachi and ThinkCyte have initiated a joint development of the AI-driven cell analysis and sorting system based on their respective technologies, expertise, and know-how. By combining ThinkCyte's high-throughput and high-content label-free single cell sorting technology and Hitachi's know-how and capability to producing stably operative instruments on a large scale, the two companies will together develop a novel reliable system to enable high-speed label-free cell isolation with high accuracy, which has been difficult to achieve with the existing cell sorting techniques, and to realize stable, low-cost and large-scale production of cells for regenerative medicine and cell therapy.

Hitachi and ThinkCyte will further advance partnerships with pharmaceutical companies and research institutes that have been developing and manufacturing regenerative medicines and cell therapy products in Japan and other countries where demand is expected to be significant, such as North America, in order to make this technology a platform for the production of regenerative medicines and cell therapy products. At the same time, taking advantage of the high-speed digital processing technologies cultivated through the development of information and communication technology by the Hitachi group, Hitachi will integrate this safe and highly reliable instrument in its value chain for regenerative medicine and contribute to the growth of the regenerative medicine and cell therapy industry.

Note:

*1. Cell manufacturing processes, including cultivation, selection, modification, preservation, product quality control, etc.

*2. Chimeric Antigen Receptor T cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy.

*3. Division of Regenerative Medicine, Japan Agency for Medical Research and Development, The final report for market research on regenerative medicine and gene therapy (2020).

*4. S, Ota et al., Ghost Cytometry, Science, 360, 1246-1251 (2018).

About the AI-driven cell analysis and cell sorting technologyThinkCyte has developed high-throughput image-based cell sorting technology based on the Ghost Cytometry technology by integrating the principles of advanced imaging technology, machine learning, and microfluidics. By applying structured illumination to cell imaging, structural information of a single cell can be converted to one-dimensional waveforms for high-throughput data analysis. Based on the judgment of a machine-learning (AI) model developed using the waveform data, target cells are isolated in a microfluidic device with high throughput and with minimal damage to the cells.

This data analysis approach eliminates time-consuming image reconstruction processes and allows high-throughput image-based single cell sorting, enabling the discrimination of cells that were previously considered difficult to distinguish by the human eye. Conventional cell sorting methods rely on the use of labels such as cell surface markers for cell sorting; in contrast, ThinkCyte's technology can sort cells without such labels by employing this unique approach. In addition to the field of regenerative medicine and cell therapy, this technology can also revolutionize drug discovery and in vitrodiagnostics fields.

About Hitachi, Ltd.Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, is focused on its Social Innovation Business that combines information technology (IT), operational technology (OT) and products. The company's consolidated revenues for fiscal year 2019 (ended March 31, 2020) totaled 8,767.2 billion yen ($80.4 billion), and it employed approximately 301,000 people worldwide. Hitachi drives digital innovation across five sectors - Mobility, Smart Life, Industry, Energy and IT - through Lumada, Hitachi's advanced digital solutions, services, and technologies for turning data into insights to drive digital innovation. Its purpose is to deliver solutions that increase social, environmental and economic value for its customers. For more information on Hitachi, please visit the company's website at https://www.hitachi.com.

About ThinkCyte, Inc.ThinkCyte, headquartered in Tokyo, Japan, is a biotechnology company, which developsinnovative life science research, diagnostics,and treatmentsusingintegrated multidisciplinary technologies, founded in 2016. The company focuses on the research and development of drug discovery, cell therapy, and diagnostic platforms using its proprietary image-based high-throughput cell sorting technology In June 2019, the company was selected for J-Startup by the Ministry of Economy, Trade and Industry of Japan. For more information on ThinkCyte, please visit the company's website at https://thinkcyte.com.

ContactsHitachi, Ltd.Analytical Systems Division, Healthcare Division, Smart Life Business Management Divisionhttps://www8.hitachi.co.jp/inquiry/healthcare/en/general/form.jsp

ThinkCyte, Inc.https://thinkcyte.com/contact

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SOURCE ThinkCyte, Inc.

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Hitachi and ThinkCyte announce collaboration to develop an AI-driven cell analysis and sorting system - BioSpace

IPS Cell Therapy Comments Off on Hitachi and ThinkCyte announce collaboration to develop an AI-driven cell analysis and sorting system – BioSpace | July 1st, 2020

This report will definitely help you make well informed decisions related to the stem cell market. The stem cell therapy market includes large number of players that are involved in development of stem cell therapies of the treatment of various diseases. Mesoblast Ltd. (Australia), Aastrom Biosciences, Inc. (U.S.), Celgene Corporation (U.S.), and StemCells, Inc. (U.S.) are the key players involved in the development of stem cell therapies across the globe.

The global stem cells market is expected to grow at an incredible CAGR of 25.5% from 2018to 2024and reach a market value of US$ 586 billion by 2025. The emergence of Induced Pluripotent Stem (iPS) cells as an alternative to ESCs (embryonic stem cells), growth of developing markets, and evolution of new stem cell therapies represent promising growth opportunities for leading players in this sector.

You Can Browse Full Report @: https://www.marketresearchengine.com/reportdetails/global-stem-cells-market-analysis-report

Due to the increased funding from Government and Private sector and rising global awareness about stem cell therapies and research are the main factors which are driving this market. A surge in therapeutic research activities funded by governments across the world has immensely propelled the global stem cells market. However, the high cost of stem cell treatment and stringent government regulations against the harvesting of stem cells are expected to restrain the growth of the global stem cells market.

The stem cell therapy market includes large number of players that are involved in development of stem cell therapies of the treatment of various diseases. Mesoblast Ltd. (Australia), Aastrom Biosciences, Inc. (U.S.), Celgene Corporation (U.S.), and StemCells, Inc. (U.S.) are the key players involved in the development of stem cell therapies across the globe.

This market research report categorizes the stem cell therapy market into the following segments and sub-segments:

The Global Stem Cell Market this market is segmented on the basis of Mode of Therapy, Therapeutic Applications and Geography.

By Mode of Therapy this market is segmented on the basis of Allogeneic Stem Cell Therapy Market and Autologous Stem Cell Therapy Market. Allogeneic Stem Cell Therapy Market this market is segmented on the basis of CVS Diseases, CNS Diseases, GIT diseases, Eye Diseases, Musculoskeletal Disorders, Metabolic Diseases, Immune System Diseases, Wounds and Injuries and Others. Autologous Stem Cell Therapy Market this market is segmented on the basis of GIT Diseases, Musculoskeletal Disorders, CVS Diseases, CNS Diseases, Wounds and Injuries and Others. By Therapeutic Applications this market is segmented on the basis of Musculoskeletal Disorders, Metabolic Diseases, Immune System Diseases, GIT Diseases, Eye Diseases, CVS Diseases, CNS Diseases, Wounds and Injuries and Others.

By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

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Table of Contents

1 INTRODUCTION

2 Research Methodology

2.1 Research Data2.1.1 Secondary Data2.1.1.1 Key Data From Secondary Sources2.1.2 Primary Data2.1.2.1 Key Data From Primary Sources2.1.2.2 Breakdown of Primaries2.2 Market Size Estimation2.2.1 Bottom-Up Approach2.2.2 Top-Down Approach2.3 Market Breakdown and Data Triangulation2.4 Research Assumptions

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Insights

7 Global Stem Cell Therapy Market, By Type

8 Global Stem Cell Therapy Market, By Therapeutic Application

9 Global Stem Cell Therapy Market, By Cell Source

10 Stem Cell Therapy Market, By Region

11 Competitive Landscape

12 Company Profiles

12.1 Introduction

12.1.1 Geographic Benchmarking

12.2 Osiris Therapeutics, Inc.

12.3 Medipost Co., Ltd.

12.4 Anterogen Co., Ltd.

12.5 Pharmicell Co., Ltd.

12.6 Holostem Terapie Avanzate Srl

12.7 JCR Pharmaceuticals Co., Ltd.

12.8 Nuvasive, Inc.

12.9 RTI Surgical, Inc.

12.10 Allosource

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Global Stem Cells Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By MRE - Cole of Duty

IPS Cell Therapy Comments Off on Global Stem Cells Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By MRE – Cole of Duty | June 26th, 2020

iPSC are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes. For example, iPSC can be prodded into becoming beta islet cells to treat diabetes, blood cells to create new blood free of cancer cells for a leukemia patient, or neurons to treat neurological disorders.

In late 2007, a BSCRC team of faculty, Drs. Kathrin Plath, William Lowry, Amander Clark, and April Pyle were among the first in the world to create human iPSC. At that time, science had long understood that tissue specific cells, such as skin cells or blood cells, could only create other like cells. With this groundbreaking discovery, iPSC research has quickly become the foundation for a new regenerative medicine.

Using iPSC technology our faculty have reprogrammed skin cells into active motor neurons, egg and sperm precursors, liver cells, bone precursors, and blood cells. In addition, patients with untreatable diseases such as, ALS, Rett Syndrome, Lesch-Nyhan Disease, and Duchenne's Muscular Dystrophy donate skin cells to BSCRC scientists for iPSC reprogramming research. The generous participation of patients and their families in this research enables BSCRC scientists to study these diseases in the laboratory in the hope of developing new treatment technologies.

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Induced Pluripotent Stem Cells (iPS) - UCLA Broad Stem ...

IPS Cell Therapy Comments Off on Induced Pluripotent Stem Cells (iPS) – UCLA Broad Stem … | June 23rd, 2020

Global Stem Cell Therapy Market report is aimed at highlighting a first-hand documentation of all the best practices in the Stem Cell Therapy industry that subsequently set the growth course active. These vital market oriented details are highly crucial to overcome cut throat competition and all the growth oriented practices typically embraced by frontline players in the Stem Cell Therapy market. Various factors and touch points that the research highlights in the report is a holistic, composite amalgamation of product portfolios of market participants, growth multiplying practices and solutions, sales gateways as well as transaction modes that coherently reflect a favorable growth prospect scenario of the market.

Get sample copy of Stem Cell Therapy Market report @https://www.adroitmarketresearch.com/contacts/request-sample/691

In addition, study report offers an array of opportunities for the players participating in the industry. This ultimately leads into the growth of the global Stem Cell Therapy market. Furthermore, report offers a comprehensive study on market size, revenue, sales, growth factors and risks involved in the growth of the market during the forecast period. The factors which are influencing the growth the market are mentioned in the report as well as the challenges which can hamper the growth of the market over the forecast period.

Full browse the report description and TOC:https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

The research report encourages the readers to comprehend the importance of quality, shortcomings if any and deep investigation for every member independently by giving the global data of great importance about the market. Consequently, the research report presents the organization profiles and deals investigation of the considerable number of vendors which can assist the customers with taking better choice of the products and services. The end clients of the global Stem Cell Therapy market can be sorted based on size of the endeavour. This research report presents the open doors for the players of the global Stem Cell Therapy market. It additionally offers plans of action which can be taken and market conjectures that would be required.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on application, the market has been segmented into:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

The company profile section also focusses on companies planning expansions along with mergers & acquisitions, new initiatives, R&D updates and financial updates. But, one of the most important aspects focused in this study is the regional analysis. Region segmentation of markets helps in detailed analysis of the market in terms of business opportunities, revenue generation potential and future predictions of the market. For Stem Cell Therapy market report, the important regions highlighted are North America, South America, Asia, Europe and Middle East. The companies focused on in this report are pioneers in the Stem Cell Therapy market. The uplifting of any region in the global market is dependent upon the market players working in that region.

A qualitative and quantitative analysis of the Stem Cell Therapy market valuations for the expected period is presented to showcase the economic appetency of the global Stem Cell Therapy industry. In addition to this, the global research report comprises significant data regarding the market segmentation which is intended by primary and secondary research methodologies. This research report offers an in-depth analysis of the global Stem Cell Therapy industry with recent and upcoming market trends to offer the impending investment in the Stem Cell Therapy market. The report includes a comprehensive analysis of the industry size database along with the market prediction for the mentioned forecast period. Furthermore, the Stem Cell Therapy market research study offers comprehensive data about the opportunities, key drivers, and restraints with the impact analysis.

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Global Stem Cell Therapy Market 2020: Size, Share, Growth Rate, Revenue and Volume, Key-Players, Top Regions and Forecast Till 2025 - Cole of Duty

IPS Cell Therapy Comments Off on Global Stem Cell Therapy Market 2020: Size, Share, Growth Rate, Revenue and Volume, Key-Players, Top Regions and Forecast Till 2025 – Cole of Duty | June 23rd, 2020

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024)" report has been added to ResearchAndMarkets.com's offering.

This report provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Regenerative medicines emphasise on the regeneration or replacement of tissues, cells or organs of the human body to cure the problem caused by disease or injury. The treatment fortifies the human cells to heal up or transplant stem cells into the body to regenerate lost tissues or organs or to recover impaired functionality. There are three types of stem cells that can be used in regenerative medicine: somatic stem cells, embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells).

The regenerative medicine also has the capability to treat chronic diseases and conditions, including Alzheimer's, diabetes, Parkinson's, heart disease, osteoporosis, renal failure, spinal cord injuries, etc. Regenerative medicines can be bifurcated into different product type i.e., cell therapy, tissue engineering, gene therapy and small molecules and biologics. In addition, on the basis of material regenerative medicine can be segmented into biologically derived material, synthetic material, genetically engineered materials and pharmaceuticals.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

Market Dynamics

Growth Drivers

Challenges

Market Trends

Companies Profiled

For more information about this report visit https://www.researchandmarkets.com/r/ufteqn

Read more:
Global Regenerative Medicine Market (2020 to 2024) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com - Business Wire

IPS Cell Therapy Comments Off on Global Regenerative Medicine Market (2020 to 2024) – Size & Forecast with Impact Analysis of COVID-19 – ResearchAndMarkets.com – Business Wire | June 18th, 2020

Yoni Yahav, 43, has been in prison five times. When he was released for the fifth time about two weeks ago, after nine months imprisonment, he swore that it would also be his last time. Despite his lengthy history behind bars, what broke him was actually a few months in Sharon prison. Conditions there are intolerable, he said. Its terribly overcrowded, eight in a cell. People were worried during the coronavirus.

Yahav decided not to remain silent. Already in prison he started a Facebook page called Protest of the Prisoners describing the tough conditions in Israeli prisons. Since his release he has gone public, and demonstrates with families of prisoners against the overcrowded cells and the poor living conditions.

LISTEN: Annexation vexation comes between Bibi and the settlersHaaretz

Prisoners are afraid to unite because its easy for the Israel Prison Service to separate them, he says. Theyre in charge of everything family visits, conjugal visits. A prisoner knows that if he opposes the system he wont be able to embrace his child. Prisoners have no lobby and no elected official wants to help them. To date he has organized demonstrations in front of the Knesset and the home of Public Security Minister Amir Ohana, against the proposed law to prevent attorneys visits to prison.

The prisoners stories led him to an awakening years after he became debt-ridden and entered the world of crime. He describes his time in crime organizations, when he was involved in fraud, money laundering and extortion, as a horrible life. Its a life of greed and wars of survival. Youre always looking who has a more expensive car, who lives on a higher floor but its also living all day looking behind your shoulder, sideways, checking the bottom of your car and your wifes car. It means switching cars and being afraid of the police.

He adds that prison doesnt do its job of rehabilitation just the opposite. You enter prison and leave twice as much a criminal, because you connect to people there, and if you take sides, immediately youre the enemy of the other camp and youre marked. He says, The IPS isnt interested in people, or in prisoner rehabilitation, because fewer prisoners means less money. For them were a money factory, were returning clients, and they make sure to maintain us.

Instead of the therapy he didnt receive, hes trying now to help prisoners who were left behind. I realized that I can take care of myself only if I help others, those who ate from the same plate as me. He recruited lawyers and prisoner activists, and last week they demonstrated in front of the Knesset during an Internal Affairs Committee meeting about prison living conditions.

They are planning additional demonstrations against the IPS commissioner and legal adviser, and meanwhile Yahav wants one other thing: For the public to know what happens in prison. How the fleas take over the cells, mice, inferior conditions. Arent people in prison human beings? So theyll say Im a criminal, but this criminal is now speaking for the others who cant speak, and he wont rest until the criminals with rank obey the [Basic] Law on Human Dignity and Freedom, just as I paid my debt to society when I broke the law and went to prison. I wont let them get away with it.

The system may be able to easily dismiss Yahavs complaints because of his serious crimes, and the IPS believes that all he wants is revenge. But hes right: Already in 2017 the High Court of Justice decided that the government must provide every prisoner with living space of at least 4.5 square meters, but although this was supposed to happen by May 2020, the IPS claimed that the space is available to only 40 percent of prisoners. In Europe the average is 8 square meters. In the end the court postponed implementation to an unknown date.

Previously, in an attempt to carry out the ruling, the government took several steps: First, building a state-of-the-art prison in Megiddo with 2,000 places, in a project including tourism initiatives. The second important step was moving releases through expanded administrative release, in which prisoners are sometimes released even six months early, regardless of their crimes or whether theyre still considered dangerous.

Former Public Security Minister Gilad Erdan decided that expanded administrative release should apply as long as there are over 14,000 prisoners. But the coronavirus reduced the number of arrests to 70 percent of their number in the same period last year, leaving the lowest number of prisoners in Israel in the past 20 years. The number is now 13,800 (compared to 18,000 in 2010). So the early releases were halted and construction of the new prison was frozen.

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The Finance Ministry said that due to the low number of inmates there is no longer a need for a new, spacious prison, adding that the IPS can observe the court rulings without it. The law enforcement system claimed that the number of prisoners who receive the required space is greater than the IPS claims.

The decline in the number of prisoners is now resulting in complaints about the inflated manpower in the IPS, with the treasury demanding that the agency most of whose budget is invested in salaries and pensions streamline its operations. But that wont improve the poor conditions of the prisoners: The prisons are obsolete, there are fleas everywhere and crowded conditions are still prevalent.

The small number of prisoners is a problem for the IPS: On one hand, the fewer the prisoners, the lower the budgets. That means that no new prisons will be built and there will be less manpower. On the other hand, a decline in the number of prisoners would increase the living space per prisoner. Ohana now has to decide whether to restore the early releases by lowering the maximum number to 13,000, which would mean fewer prisoners and less money.

Its a cynical battle between the treasury and the IPS, says Avi Himi, chairman of the Israel Bar Association. He said the expanded administrative releases should be instituted immediately, because of the poor prison conditions.

Acting IPS Commissioner Asher Vaknin said the numbers will increase to 17,000, and even if there are 1,000 vacant places designated for Palestinian security prisoners, he cant put regular criminals there. He insisted that only the IPS can plan prison arrangements. However, the enforcement authorities says that the IPS wants as many prisoners as possible, but we have dropped to 13,000 prisoners, and the crime situation hasnt worsened.

The IPS stated: The IPS is responsible only for the supply of places in prison, and not for populating them. The IPS takes care of prisoner welfare and security and is constantly trying to improve the treatment and rehabilitation of criminal prisoners, prevent recidivism and help prisoners return to the community. In the past two years millions of shekels were invested in improving living conditions and increasing living space. The first stage of the High Court decision has been completed and we are beginning the second stage.

Continued here:
Vowing to never go back, Ex-con seeks to improve intolerable conditions in Israeli jails - Haaretz

IPS Cell Therapy Comments Off on Vowing to never go back, Ex-con seeks to improve intolerable conditions in Israeli jails – Haaretz | June 8th, 2020

Ample Market Research has recently published a report Human Embryonic Stem Cells Market . The key objective of this report is to highlight various trends and dynamics, new and innovative technology and mergers and acquisitions that are expected to make a positive impact on the overall industry. This report studies the Human Embryonic Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2014-2018 and forecast data 2019-2025; This report provides a detailed analysis of the prospects for the global Human Embryonic Stem Cells industry up to 2024, including an assessment of the impact of COVID-19.

To know How COVID-19 Pandemic Will Impact This Market/Industry -Request a sample copy of the report: https://www.amplemarketreports.com/sample-request/global-human-embryonic-stem-cells-market-1731516.html

Human Embryonic Stem Cells Market Latest Research Report 2018- 2025 covers a complete market structure across the world with a detailed industry analysis of major key factors. This report provides strategic recommendations consulted by the industrial experts including market forecasts, profit, supply, raw materials, manufacturing expenses, the proportion of manufacturing cost structure, latest market trends, demands and much more.

Global Human Embryonic Stem Cells Market is valued approximately USD XX billion in 2019 and is anticipated to grow with a healthy growth rate of more than XX% over the forecast period 2020-2026. Due to COVID-19 pandemic, the market is facing challenges because of government protocols to stay at home across the world. Human Embryonic Stem Cells (hESCs) are derived from blastocyst and are capable of differentiating into number of cell types that make up the human body as well as it replicates indefinitely and produce non-regenerative tissues such as neural and myocardial cells. They are used in treating a number of blood and genetic disorders related to the immune system, cancers, and disorders as well as used in investigational studies of early human development, genetic diseases and toxicology testing. The technological advancement involving stem cells therapy, rising demand for regenerative medicines, R&D in toxicology testing, technological advancements for the production of embryonic stem cells through alternative methods and increasing prevalence of genetic disorders are the few factors responsible for growth of the market over the forecast period. Furthermore, the introduction of innovative products and other strategic advancements by market players will create lucrative opportunities for the market. For instance, as per companys news release in January 2019, Stemcell Technologies Inc. launched mTeSRl Plus, an enhanced version of mTeSR1. mTeSR Plus is the stabilized feeder-free maintenance medium for human embryonic stem (ES) and induced pluripotent stem (iPS) cells. However, ethical concern related to stem cell research is the major factor restraining the growth of global Vegetable Chips market during the forecast period.

The regional analysis of global Human Embryonic Stem Cells market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. Asia Pacific is the leading/significant region across the world due to the presence of several prominent entities incorporated in the U.S. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2026.

This report discusses the key drivers influencing Human Embryonic Stem Cells market growth, demand, the challenges and the risks faced by key players and the market as a whole. It also analyzes key emerging trends and their impact on current and future development.

Human Embryonic Stem Cells market report presents the market competitive landscape and a corresponding detailed analysis of the major vendor/manufacturers in the market.

Key players analyzed in the Human Embryonic Stem Cells Insight Report: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell Technologies Inc., Biotime, Inc. / Cell Cure Neurosciences LTD, Thermo Fisher Scientific, Inc., CellGenix GmbH, ESI BIO, PromoCell GmbH, Lonza Group AG, Kite Pharma, Cynata Therapeutics Ltd.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

Browse Detailed TOC, Tables, Figures, Charts And Companies Mentioned In Human Embryonic Stem Cells Market Research Report At: https://www.amplemarketreports.com/report/global-human-embryonic-stem-cells-market-1731516.html

Strategic Points Covered in Table of Contents

Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global Conductive Nylon market, years considered, and study objectives. Additionally, it touches the segmentation study provided in the report on the basis of the type of product and application.

Executive Summary: It gives a summary of key studies, viz. production, market growth rate, competitive landscape, market drivers, trends, and issues, and macroscopic indicators.

Production by Region: Here, the report provides information related to import and export, revenue, production, and key players of all regional markets studied.

Profile of Manufacturers: Each player profiled in this section is studied on the basis of SWOT analysis, their products, production, value, capacity, and other vital factors.

Market Size by Manufacturer

Consumption by Region

Market Size by Type,by Application

Production Forecast and Consumption Forecast

Industry Chain, Upstream, and Downstream Customers Analysis

Key Findings, Opportunities and Challenges, Threats, and Affecting Factors

Appendix

Get Complete Report in your Inbox within 24 hours Now at : https://www.amplemarketreports.com/buy-report.html?report=1731516&format=1

In the end, this report additionally presents product specification, producing method, and product cost structure. Production is separated by regions, technology, and applications. The Human Embryonic Stem Cells Market report includes investment come analysis and development trend analysis. The key rising opportunities of the fastest growing international Human Embryonic Stem Cells industry segments are coated throughout this report. This report provides information about the import, export, consumption and consumption value. The report then provides one of the most crucial aspects of the Human Embryonic Stem Cells Market the forecast for the next five to six years based on the previous as well as current data.

About Ample Market Research

Ample Market Research provides comprehensive market research services and solutions across various industry verticals and helps businesses perform exceptionally well. Attention to detail, consistency, and quality are elements we focus on. However, our mainstay remains to be knowledge, expertise, and resources to make us industry players.

Our mission is to capture every aspect of the market and offer businesses a document that makes solid grounds for crucial decision making.

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Read more:
Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell...

IPS Cell Therapy Comments Off on Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell… | June 4th, 2020

DUBLIN, May 18, 2020 /PRNewswire/ -- The "Global Stem Cell Partnering Terms and Agreements 2010-2020" report has been added to ResearchAndMarkets.com's offering.

This report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Stem Cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Stem Cell agreements announced in the life sciences since 2010.

The report takes the reader through a comprehensive review Stem Cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Stem Cell partnering deals.

The report presents financial deal term values for Stem Cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Stem Cell partnering field; both the leading deal values and most active Stem Cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 600 online deal records of actual Stem Cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

The initial chapters of this report provide an orientation of Stem Cell dealmaking.

A comprehensive series of appendices is provided organized by Stem Cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Stem Cell partnering and dealmaking since 2010.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Stem Cell technologies and products.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/9pqrta

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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Continued here:
Global Stem Cell Partnering Deals Collection (2010-2020): Access to Headline, Upfront, Milestone and Royalty Data - PRNewswire

IPS Cell Therapy Comments Off on Global Stem Cell Partnering Deals Collection (2010-2020): Access to Headline, Upfront, Milestone and Royalty Data – PRNewswire | May 18th, 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

Property and equipment, net

898

1,126

Deposits and other long-term assets

111

111

Intangible assets, net

2,011

2,151

TOTAL ASSETS

$

5,092

$

7,442

LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)

CURRENT LIABILITIES

Accounts payable and accrued liabilities

$

2,184

$

1,582

Loan due to Juvenescence, net of debt issuance cost

1,767

-

Related party payables, net

181

64

Deferred revenues

407

283

Right-of-use lease liability

325

428

Insurance premium liability and other current liabilities

603

940

Total current liabilities

5,467

3,297

Loan due to Juvenescence, net of debt issuance cost

-

1,528

TOTAL LIABILITIES

$

5,467

$

4,825

Commitments and contingencies

STOCKHOLDERS EQUITY (DEFICIT)

Preferred stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding as of March 31, 2020 and December 31, 2019

-

-

View post:
AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Insurance News Net

IPS Cell Therapy Comments Off on AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Insurance News Net | May 18th, 2020

DUBLIN--(BUSINESS WIRE)--The "Global Stem Cell Partnering Terms and Agreements 2010-2020" report has been added to ResearchAndMarkets.com's offering.

This report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Stem Cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Stem Cell agreements announced in the life sciences since 2010.

The report takes the reader through a comprehensive review Stem Cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Stem Cell partnering deals.

The report presents financial deal term values for Stem Cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Stem Cell partnering field; both the leading deal values and most active Stem Cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 600 online deal records of actual Stem Cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

The initial chapters of this report provide an orientation of Stem Cell dealmaking.

A comprehensive series of appendices is provided organized by Stem Cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Stem Cell partnering and dealmaking since 2010.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Stem Cell technologies and products.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/84edx3

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Global Stem Cell Partnering Terms and Agreements 2010-2020 - ResearchAndMarkets.com - Business Wire

IPS Cell Therapy Comments Off on Global Stem Cell Partnering Terms and Agreements 2010-2020 – ResearchAndMarkets.com – Business Wire | May 18th, 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

The Cell and Gene Therapy Catapult (CGT Catapult) and Kyoto, Japan-based CiRA Foundation are launching a new collaborative research project focused on induced pluripotent stem (iPS) cell characterisation.

With the move, the groups are hoping to further the application of iPS cell technologies for the manufacture of regenerative medicine products.

The potential of distinct iPS cell lines for differentiation into specific cell types is usually biased towards some cell line-specificity which, the parties note, is very difficult to predict. As such, in order to select an appropriate iPS cell line for clinical trials it is necessary to differentiate several candidate cell lines, which is time-consuming.

CGT Catapult and CiRA plan to explore novel methods of evaluating cell differentiation and aim to establish reliable tests to predict the potential of iPS cell to differentiation bias, a capability that would help to advance the use of iPS cells for regenerative medicine products.

We are honoured to collaborate with CiRA Foundation, an organisation with world-leading capabilities in iPS cell technology, and to be the first group to utilise CiRAs innovative iPS cell lines outside of Japan, said CGT's chief executive Matthew Durdy

This is a truly exciting project to help further the application and manufacture of iPS cells into cell therapies. We look forward to progressing this promising research together, which has potential benefits for the global advanced therapies industry.

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Cell and Gene Therapy Catapult links with Japan's CiRA Foundation - PharmaTimes

IPS Cell Therapy Comments Off on Cell and Gene Therapy Catapult links with Japan’s CiRA Foundation – PharmaTimes | May 13th, 2020

Advancing your induced pluripotent stem cells or human embryonic stem cell therapy research to clinical applications requires careful material selection because the quality of starting materials significantly impact the properties of your final stem cell therapy product. Gibco CTS products have been developed to ease the transition from stem cell therapy research to clinical applications by providing high quality GMP manufactured, commercial scale ancillary materials with a high degree of qualification, traceability and regulatory documentation. In an effort to help you maximize the potential of your stem cell research and therapy, and simplify the transition to clinic-ready processes, we offer an extensive selection of research use stem cell research products with complementary CTS formulations. Our CTS products are used in commercially approved cell therapies as well as over 100 clinical trials and are backed by our professional regulatory support and over 30 years of GMP manufacturing experience.

Induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs) , sometimes collectively referred to as pluripotent stem cells (PSCs), are cells that have the ability to renew themselves indefinitely and differentiate into almost any cell type when exposed to the right microenvironment. These unique properties enable the application of induced pluripotent stem cells and embryonic stem cells in disease modeling, drug discovery, drug toxicity testing, and cell therapy. Strikingly, most embryonic stem cell and induced pluripotent stem cell applications have the potential to improve human health, none more directly so than ESC or iPSC therapy. The most intuitive approach for ES or iPS cell therapy is to transplant PSC-derived cells for the direct replacement of damaged or degenerated cells or tissue. However, there are many other approaches to ES or iPS stem cell therapy such as transplanting PSC-derived cells that then release signals triggering endogenous repair mechanisms.

At Thermo Fisher Scientific, we support the development of your human embryonic stem cell therapy or induced pluripotent stem cell therapy from the earliest stages of research and all the way to the clinic. We offer high-quality products across the iPS cell therapy workflow from reprogramming to differentiation. Most Gibco media and supplements for culture and differentiation are manufactured under GMP conditions at sites that use methods and controls that conform to current Good Manufacturing Practices (cGMP) for medical devices. These manufacturing sites are ISO 13485 and ISO 9001certified, and the rigorous practices we adhere to at these sites help ensure the consistency, reliability, and high quality of a wide variety of iPSC therapy workflow reagents.

To further help you maximize the potential of your research and streamline your transition to the clinic, we offer Gibco Cell Therapy Systems (CTS) equivalents for many of our research-use products. In addition to GMP manufacturing, Gibco CTS products undergo quality control testing and are accompanied by appropriate documentation so you can transition your cell therapy to the clinic with confidence.

*Adherence to supplier related responsibilities of USP<1043>

First off-the-shelf reprogramming system manufactured in accordance with GMP requirements. CTS CytoTune 2.1 kit offers high-efficiency Sendai delivery of reprogramming factors.

Click image to enlarge

Efficient reprogramming from adult human dermal fibroblasts, T cells, and CD34+ cells. These data demonstrate that the CytoTune-iPS 2.1 kit can be used to successfully reprogram human dermal fibroblasts (HDFa), T cells, and CD34+ cells.

Gibco CTS Essential 6 Medium is a xeno-free, feeder-free, cGMP-manufactured medium which supports the spontaneous or directed differentiation of human pluripotent stem cells (PSCs) and the reprogramming of somatic cells.

Based on the widely cited Gibco Essential 8 Medium, Gibco CTS Essential 8 Medium is the first globally available human- and animal originfree culture medium for human pluripotent stem cells (hPSCs) and is designed to meet international regulatory requirements for cell therapy.

Click image to enlarge

Using Applied Biosystems TaqMan hPSC Scorecard Panel analysis, Gibco CTS Essential 8 Medium and research-use-only Essential 8 Medium were shown to support comparable expression of PSC markers and lineage markers in undifferentiated PSCs and PSC-derived embryoid bodies.

CTS Vitronectin (VTN-N) Recombinant Human Protein is a defined matrix for feeder-free culture of iPSCs. Designed in the laboratory of James Thomson, this recombinant protein is intended for use with the CTS Essential 8 culture system.

CTS RevitaCell Supplement (100X) is an animal-origin-free, chemically defined supplement used with PSCs for post-thaw recovery or in combination with CTS Essential 8 Medium for single cell passaging. To minimize both the loss of cell viability and differentiation of PSCs, use the CTS PSC Cryopreservation Kit.

CTS Versene is a gentle non-enzymatic cell dissociation reagent for use in routine clump passaging of PSCs while maintaining viability over multiple passages.

For the cryopreservation and recovery of PSCs, the CTS PSC Cryopreservation Medium and CTS RevitaCell Supplement minimize the loss of cell viability and maximize post-thaw recovery when used in combination. Both reagents are included in the CTS PSC Cryopreservation Kit.

The CTS PSC Cryopreservation Medium is a xeno-free solution for the cryopreservation of pluripotent stem cells (PSCs). Both CTS PSC Cryopreservation Medium and CTS RevitaCell supplement are included in the CTS PSC Cryopreservation Kit that helps minimize loss of cell viability and maximize post-thaw recovery.

CTS KnockOut SR XenoFree Medium is a defined, xeno-free serum replacement based on the traditional Gibco KnockOut Serum Replacement, which has been cited in more than 2,000 publications and trusted for over 20 years.

Maintenance of pluripotency using CTS KNOCKOUT SR XenoFree Medium. Following 10 passages in either KSR (left lane) or KSR XenoFree CTS (right lane) on HFF attached with CELLstart substrate, BG01v gene expression was examined (top). Gene expression of embryoid bodies generated from the same P10 BG01v/HFF cultures (bottom).

Your choice of chemically defined human- and animal origin-free basal media for pluripotent stem cell culture. Based on traditional DMEM and DMEM/F12 formulations, these basal media are:

We offer full customization options to help meet your unique specifications for any project. Flexibility is yours in creating your own Gibco custom cell culture medium

Intended use of the products mentioned on this page vary. For specific intended use statements please refer to the product label.

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Induced Pluripotent Stem Cell (iPSC) Media and Reagents ...

IPS Cell Therapy Comments Off on Induced Pluripotent Stem Cell (iPSC) Media and Reagents … | April 27th, 2020

HAMBURG, GERMANY / ACCESSWIRE / April 22, 2020 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that it will regain global development and commercialisation rights to the iPSC-based programme for the treatment of diabetes developed under collaboration agreement with Sanofi.

Evotec has built a unique platform for iPSC-based drug discovery and cell therapy covering the generation of iPS cell lines, up to cell manufacturing of various cell types for drug screening as well as GMP production of clinical material for cell therapies. Evotec produces human beta cells in islet-like clusters from a GMP-compliant iPS cell line in a scalable bioreactor format, with extensive quality control ("QC") procedures. The beta cell programme has already achieved pre-clinical data demonstrating that they are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.

Evotec will continue the development of the beta cell programme on its own within its EVT Innovate initiative "QRbeta Therapeutics". In parallel, Evotec will explore the best strategic options for further long-term development and commercialisation. An off-the-shelf beta cell therapy product has the potential to revolutionise the treatment of insulin-dependent diabetic patients and therefore could represent a major therapeutic opportunity.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Evotec and Sanofi have developed the beta cell replacement therapy programme since 2015 in a highly productive partnership. During this time, we have made tremendous progress towards bringing a potentially game-changing treatment option to the clinic. We would like to thank Sanofi for the collaboration and its contributions. Regaining full control of this innovative and promising programme to treat diabetes is of great value for Evotec. While we are continuing to move this programme forward, we are exploring partnering options to bring this therapy to patients."

About DiabetesDiabetes mellitus ("diabetes") is a chronic incapacitating disease associated with severe lifelong conditions which require intensive monitoring and control, such as cardiovascular diseases, kidney diseases, nerve damage and eye diseases. At present, there is no cure for diabetes and only symptomatic treatment options are available. According to the International Diabetes Federation, it is estimated that 463 million people worldwide suffered from diabetes in 2019 (2017:425 million) and this number is projected to reach 578 million by 2030. The disease is a major burden to the global healthcare systems with about $ 760 bn being spent on the treatment of diabetes in 2019 and it is projected that expenditure will reach $ 825 bn by 2030.

About Beta CellsBeta cells play a key role in the pathogenesis of diabetes. Beta cells reside in clusters of hormone producing cells ("islets") within the pancreas. They respond to elevated blood glucose levels (e.g. after a meal) by secreting the glucose lowering hormone insulin. In the type 1 form of diabetes ("T1D"), beta cells are destroyed by the patient's own immune system. As a result, T1D patients must follow a life-long regimen of carefully dosed insulin injections. In patients with type 2 diabetes ("T2D"), beta cells are functionally impaired and yet have to work in the presence of metabolic stress and increased workload due to an impaired tissue insulin response. T2D is progressive, and current therapeutic options cannot prevent the deterioration of beta cell function, eventually also creating a need for insulin injections. Despite the fact that insulin treatments are important and widely used for people with diabetes, they cannot fully mimic the normal control of blood glucose levels by normal beta cells necessary to avoid acute and long-term complications of diabetes. There is a critical medical need for novel therapeutic options which can restore beta cell mass and, thereby, reduce or eliminate the need for insulin injections. Furthermore, beta cell replacement therapy also has the potential to prevent or reverse the decline in beta cell function in type 2 diabetes.

ABOUT EVOTEC SEEvotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

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FORWARD LOOKING STATEMENTSInformation set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255, gabriele.hansen@evotec.com

SOURCE: Evotec AG via EQS Newswire

View source version on accesswire.com: https://www.accesswire.com/586314/Evotec-Regains-Global-Rights-to-Beta-Cell-Replacement-Therapy

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Evotec Regains Global Rights to Beta Cell Replacement Therapy - Yahoo Finance

IPS Cell Therapy Comments Off on Evotec Regains Global Rights to Beta Cell Replacement Therapy – Yahoo Finance | April 22nd, 2020

The Food and Drug Administration approved Tukysa, which is indicated for use with two other drugs after patients have completed treatment with prior therapies targeting the protein HER2.

Tukysa inhibits the protein HER2, whose overexpression is a driver of this type of breast cancer. Under the approval, the drug will be given along with another HER2 inhibitor, Herceptin (trastuzumab), and the chemotherapy capecitabine. The Tukysa regimen is meant for use after patients have completed treatment with one or more therapies containing an anti-HER2 drug.

The approval was based on findings from a clinical trial that included 612 patients with advanced or metastatic HER2-positive breast cancer, including some whose disease had spread to the brain. Patients who took the Tukysa combination went a median 7.8 months before experiencing disease progression, compared with 5.6 months in patients in the two-drug group. In the Tukysa group, the median overall survival was 21.9 months compared with 17.4 months in the placebo/Herceptin/capecitabine group.

Common side effects associated with Tukysa were diarrhea, burning or tingling discomfort in the hands and feet, nausea, fatigue, liver damage, vomiting, inflammation of the mouth and lips, decreased appetite, abdominal pain, headache, anemia and rash. Tukysa can also cause serious side effects including severe diarrhea associated with dehydration, acute kidney injury and death.

The FDA nod was part of Project Orbis, which allows drug developers to seek approvals from the governments of multiple countries simultaneously. In this case, the FDA collaborated with drug authorities in Australia, Canada, Singapore and Switzerland. However, Tukysa was still under review in those countries as of April 17.

Tukysa was approved four months prior to the FDAs goal date, according to Dr. Richard Pazdur, director of the agencys Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in its Center for Drug Evaluation and Research. He said the early approval was an example of the FDAs commitment to expediting oncology drug development despite challenges posed by the COVID-19 pandemic and showing how their work to approve cancer therapies was not being delayed.

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

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FDA Approves Tukysa to Treat Advanced or Metastatic HER2-Positive Breast Cancer - Curetoday.com

IPS Cell Therapy Comments Off on FDA Approves Tukysa to Treat Advanced or Metastatic HER2-Positive Breast Cancer – Curetoday.com | April 18th, 2020

News Release

Wednesday, April 15, 2020

NIH-funded study offers new path to modeling eye disease, advancing therapies

Researchers have discovered a technique for directly reprogramming skin cells into light-sensing rod photoreceptors used for vision. The lab-made rods enabled blind mice to detect light after the cells were transplanted into the animals eyes. The work, funded by the National Eye Institute (NEI), published April 15 in Nature. The NEI is part of the National Institutes of Health.

Up until now, researchers have replaced dying photoreceptors in animal models by creating stem cells from skin or blood cells, programming those stem cells to become photoreceptors, which are then transplanted into the back of the eye. In the new study, scientists show that it is possible to skip the stem-cell intermediary step and directly reprogram skins cells into photoreceptors for transplantation into the retina.

This is the first study to show that direct, chemical reprogramming can produce retinal-like cells, which gives us a new and faster strategy for developing therapies for age-related macular degeneration and other retinal disorders caused by the loss of photoreceptors, said Anand Swaroop, Ph.D., senior investigator in the NEI Neurobiology, Neurodegeneration, and Repair Laboratory, which characterized the reprogrammed rod photoreceptor cells by gene expression analysis.

Of immediate benefit will be the ability to quickly develop disease models so we can study mechanisms of disease. The new strategy will also help us design better cell replacement approaches, he said.

Scientists have studied induced pluripotent stem (iPS) cells with intense interest over the past decade. IPSCs are developed in a lab from adult cells rather than fetal tissue and can be used to make nearly any type of replacement cell or tissue. But iPS cell reprogramming protocols can take six months before cells or tissues are ready for transplantation. By contrast, the direct reprogramming described in the current study coaxed skin cells into functional photoreceptors ready for transplantation in only 10 days. The researchers demonstrated their technique in mouse eyes, using both mouse- and human-derived skin cells.

Our technique goes directly from skin cell to photoreceptor without the need for stem cells in between, said the studys lead investigator, Sai Chavala, M.D., CEO and president of CIRC Therapeutics and the Center for Retina Innovation. Chavala is also director of retina services at KE Eye Centers of Texas and a professor of surgery at Texas Christian University and University of North Texas Health Science Center (UNTHSC) School of Medicine, Fort Worth.

Direct reprogramming involves bathing the skin cells in a cocktail of five small molecule compounds that together chemically mediate the molecular pathways relevant for rod photoreceptor cell fate. The result are rod photoreceptors that mimic native rods in appearance and function.

The researchers performed gene expression profiling, which showed that the genes expressed by the new cells were similar to those expressed by real rod photoreceptors. At the same time, genes relevant to skin cell function had been downregulated.

The researchers transplanted the cells into mice with retinal degeneration and then tested their pupillary reflexes, which is a measure of photoreceptor function after transplantation. Under low-light conditions, constriction of the pupil is dependent on rod photoreceptor function. Within a month of transplantation, six of 14 (43%) animals showed robust pupil constriction under low light compared to none of the untreated controls.

Moreover, treated mice with pupil constriction were significantly more likely to seek out and spend time in dark spaces compared with treated mice with no pupil response and untreated controls. Preference for dark spaces is a behavior that requires vision and reflects the mouses natural tendency to seek out safe, dark locations as opposed to light ones.

Even mice with severely advanced retinal degeneration, with little chance of having living photoreceptors remaining, responded to transplantation. Such findings suggest that the observed improvements were due to the lab-made photoreceptors rather than to an ancillary effect that supported the health of the hosts existing photoreceptors, said the studys first author Biraj Mahato, Ph.D., research scientist, UNTHSC.

Three months after transplantation, immunofluorescence studies confirmed the survival of the lab-made photoreceptors, as well as their synaptic connections to neurons in the inner retina.

Further research is needed to optimize the protocol to increase the number of functional transplanted photoreceptors.

Importantly, the researchers worked out how this direct reprogramming is mediated at the cellular level. These insights will help researchers apply the technique not only to the retina, but to many other cell types, Swaroop said.

If efficiency of this direct conversion can be improved, this may significantly reduce the time it takes to develop a potential cell therapy product or disease model, said Kapil Bharti, Ph.D., senior investigator and head of the Ocular and Stem Cell Translational Research Section at NEI.

Chavala and his colleagues are planning a clinical trial to test the therapy in humans for degenerative retinal diseases, such as retinitis pigmentosa.

The work was supported by grants EY021171, EY025667, EY025905, and EY025717 and NEI Intramural Research Program grants ZIAEY000450, ZIAEY000474 and ZIAEY000546.

The University of North Texas has a patent pending on the chemical reprogramming method reported in this paper. CIRC Therapeutics is a start-up company that plans to commercialize treatments using the technology.

This press release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Mahato B, Kaya KD , Fan Y, Sumien N, Shetty RA, Zhang W, Davis D, Mock T , Batabyal S, Ni A, Mohanty S, Han Z, Farjo R, Forster M, Swaroop A and Chavala SH. Pharmacologic fibroblast reprogramming into photoreceptors restores vision. Published online April 15, 2020 in Nature.http://dx.doi.org/10.1038/s41586-020-2201-4

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Researchers restore sight in mice by turning skin cells into light-sensing eye cells - National Institutes of Health

IPS Cell Therapy Comments Off on Researchers restore sight in mice by turning skin cells into light-sensing eye cells – National Institutes of Health | April 15th, 2020

Global Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020 is analyzed in details, to provide accurate and useful insights and market data that players can perform strong growth in the future. Experts and Chimeric Antigen Receptor (CAR) T-Cell Therapy industry analysts, which makes it legitimate and dependable compile the analysis. Readers have a thorough inspection of historical and futuristic Chimeric Antigen Receptor (CAR) T-Cell Therapy market scenarios to have a good understanding of other issues that are important with the market competition. The report offers Chimeric Antigen Receptor (CAR) T-Cell Therapy information on key players, key sections, market dynamics and assorted niches. It is a complete collection of Chimeric Antigen Receptor (CAR) T-Cell Therapy research and in-depth analysis of the market.

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Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020: Professional Survey & Competitive Dynamics Mustang Bio Inc., iCell Gene Therapeutics,...

IPS Cell Therapy Comments Off on Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020: Professional Survey & Competitive Dynamics Mustang Bio Inc., iCell Gene Therapeutics,… | April 12th, 2020

DetailsCategory: More NewsPublished on Thursday, 02 April 2020 14:06Hits: 400

HAMBURG, Germany, and TORONTO, Canada I April 02, 2020 I Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. announced today that the companies have entered into a licensing and investment agreement.

Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLas proprietary iPS cell lines iACT Stealth Cells, which are genetically modified to prevent immune rejection of derived cell therapy products (cloaking). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the FailSafe mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotecs cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLas supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLas technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotecs position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotecs multimodality discovery and development platform.

Mahendra Rao, MD, PhD, CEO at panCELLa, added: We welcome the partnership with Evotec. Evotecs widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board.

No financial details of the agreement were disclosed.

About Evotec and iPSC

Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanakas lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon for the discovery that mature cells can be reprogrammed to become pluripotent. Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

Evotec has built an industrialised iPSC infrastructure that represents one of the largest and most sophisticated iPSC platforms in the industry. Evotecs iPSC platform has been developed over the last years with the goal to industrialise iPSC-based drug screening in terms of throughput, reproducibility and robustness to reach the highest industrial standards, and to use iPSC-based cells in cell therapy approaches via the Companys proprietary EVOcells platform.

About cell therapy and panCELLas FailSafe iPSC technology

Cell therapy, one of the most promising regenerative medicine approaches, replaces a patients missing or broken cells with functioning cells from a range of different sources, either from a donor, from the patients own material, or from stem cells. The advent of induced pluripotent stem cells (iPSC) has opened up stem cells as an almost unlimited source of consistent-quality material for such cell therapies. At the same time, differentiating cell therapies from a single validated source circumvents critical risks of contamination associated with administering both donor and patient cell material.

However, the patients immune system will treat such iPSC-based transplants as foreign and use the bodys immune system to counteract the therapy, thus undermining its long-term efficacy. While organ transplants require an often lifelong regimen of immunosuppressants, iPSC-derived cells used for cell therapies can be cloaked to make them undetectable by the patients immune system, thus avoiding rejection and enabling effective long-term relief of the patients symptoms.

To increase the safety of such iPSC-derived cell products, panCELLas proprietary FailSafe technology is able to inactivate any iPSC-derived proliferating cell before and after transplantation through the use of a readily available anti-infective medication. FailSafe is the only quantifiable safety switch on the market which is expected to be critical for regulators, clinicians and patients to make informed decisions when evaluating treatment options.

ABOUT PANCELLA INC.

Incorporated in August 2015, panCELLa (www.pancella.com) was founded by Dr Andras Nagy and Dr Armand Keating based on Dr Nagys ground-breaking work in the area of stem cell research. Through panCELLa, Drs Keating and Nagy are seeking to create an effective cell therapy derived from stem cells, which are modified to provide a sufficient and very high level of safety before and after the cells are introduced to the patient. panCELLa serves those companies developing products from stem cells. panCELLa seeks to create universal off the shelf FailSafe Cells and to assist pharmaceutical and biotechnology sectors to achieve such with their own cell lines. Targeted medical applications include deadly, debilitating, or aggressive diseases requiring immediate treatment where there is no time to cultivate a customized stem cell treatment from the patient (i.e. cancer, cardiac infarct, diabetes, stroke and spinal cord injury).

SOURCE: Evotec

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Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa | More News | News Channels -...

IPS Cell Therapy Comments Off on Evotec Expands its iPSC-Based Cell Therapy Platform EVOcells Through Licensing Agreement with panCELLa | More News | News Channels -… | April 6th, 2020