Constellation Pharmaceuticals to Host Analyst / Investor Event to Discuss Update of MANIFEST Clinical Trial for CPI-0610 Presented at ASH Meeting
By Dr. Matthew Watson
CAMBRIDGE, Mass., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, will host a virtual analyst/investor event and conference call on December 7 at 8:00 AM EDT to discuss the data from two oral presentations and two posters on the MANIFEST clinical trial for CPI-0610 being presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
Ovid Therapeutics to Present at the American Epilepsy Society (AES) 2020 Virtual Congress
By Dr. Matthew Watson
Abstracts will be presented from the TAK-935/OV935 (soticlestat) clinical development program in Dravet syndrome or Lennox-Gastaut syndrome (Phase 2 ELEKTRA study) and OV101 (gaboxadol) clinical development program in Angelman syndrome (Phase 2 STARS study) Abstracts will be presented from the TAK-935/OV935 (soticlestat) clinical development program in Dravet syndrome or Lennox-Gastaut syndrome (Phase 2 ELEKTRA study) and OV101 (gaboxadol) clinical development program in Angelman syndrome (Phase 2 STARS study)
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Ovid Therapeutics to Present at the American Epilepsy Society (AES) 2020 Virtual Congress
Theratechnologies to Present at the Piper Sandler Virtual Healthcare Conference
By Dr. Matthew Watson
MONTREAL, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that some of its management team members will be participating in the upcoming Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1 and 2, 2020.
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Theratechnologies to Present at the Piper Sandler Virtual Healthcare Conference
Tarsius Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference
By Dr. Matthew Watson
TEL-AVIV, Israel, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Tarsius Pharma, a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, is pleased to announce that management will participate in the Piper Sandler 32nd Annual Healthcare Conference, being held virtually on November 30th to December 3rd, 2020. In advance of the virtual conference and investor meetings, a pre-recorded corporate update given by Dr. Daphne Haim-Langford, CEO and founder of Tarsius Pharma, will be made available, on Monday, November 23rd, in the News & Events section of the company's website. Replay of the webcast will be available for 90 days following the event.
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Tarsius Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference
iTeos to Present at Piper Sandler 32nd Annual Healthcare Conference
By Dr. Matthew Watson
CAMBRIDGE, Mass. and GOSSELIES, Belgium, Nov. 23, 2020 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today announced that management will present at the Piper Sandler 32nd Annual Healthcare Conference, taking place December 1 – 3, 2020.
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iTeos to Present at Piper Sandler 32nd Annual Healthcare Conference
Galecto Appoints Experienced Healthcare Executive Jayson Dallas to Board of Directors
By Dr. Matthew Watson
BOSTON and COPENHAGEN, Denmark, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that senior healthcare executive Jayson Dallas has joined its Board of Directors, effective November 19.
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Galecto Appoints Experienced Healthcare Executive Jayson Dallas to Board of Directors
BeyondSpring to Participate in Upcoming Evercore ISI 2020 Conference
By Dr. Matthew Watson
NEW YORK, Nov. 23, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to transform the lives of patients with unmet medical needs, today announced that management will provide a corporate overview at the 2020 Evercore ISI HealthCONx Conference on December 2, 2020.
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BeyondSpring to Participate in Upcoming Evercore ISI 2020 Conference
Neuronetics® Receives FDA Clearance for Three-Minute TouchStar™ Treatment Protocol
By Dr. Matthew Watson
TouchStar theta burst protocol leverages NeuroStar® Advanced Therapy’s patented Contact Sensing technology to help ensure the optimum prescribed treatment dose to patients TouchStar theta burst protocol leverages NeuroStar® Advanced Therapy’s patented Contact Sensing technology to help ensure the optimum prescribed treatment dose to patients
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Neuronetics® Receives FDA Clearance for Three-Minute TouchStar™ Treatment Protocol
NextCure to Present at Piper Sandler Virtual 32nd Annual Healthcare Conference
By Dr. Matthew Watson
BELTSVILLE, Md., Nov. 23, 2020 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced that it will participate in a fireside chat at the Piper Sandler Virtual 32nd Annual Healthcare Conference on December 1st.
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NextCure to Present at Piper Sandler Virtual 32nd Annual Healthcare Conference
Antares Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference
By Dr. Matthew Watson
EWING, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer has participated in a fireside chat presentation and will host investor meetings at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held on December 1-3, 2020.
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Antares Pharma to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference
Sanofi: Disclosure of trading in own shares
By Dr. Matthew Watson
Disclosure of trading in own shares from November 17, 2020 to November 20, 2020
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Sanofi: Disclosure of trading in own shares
Selvita to acquire Fidelta from Galapagos
By Dr. Matthew Watson
-Strengthening Selvita’s position as one of the largest preclinical contract research organizations in Europe -
Genetic Technologies Interview Aired on Bloomberg International on the RedChip Money Report
By Dr. Matthew Watson
MELBOURNE, Australia, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE, “Company”) is pleased to announce an interview with its interim-CEO, Dr. Jerzy Muchnicki aired on The RedChip Money Report television program. The RedChip Money Report airs in 100 million homes on Sundays at 6 p.m. local time in every country in Europe on Bloomberg International.
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Genetic Technologies Interview Aired on Bloomberg International on the RedChip Money Report
Lumos Pharma to Participate in December Investor Conferences
By Dr. Matthew Watson
AUSTIN, Texas, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that the company will present and host one-on-one meetings at the following virtual investor conferences to be held in December:
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Lumos Pharma to Participate in December Investor Conferences
The Stem Cell-Derived Cells Market to witness explicit growth from 2019 and 2029 – The Haitian-Caribbean News Network
By daniellenierenberg
Stem cell-derived cells are ready-made human induced pluripotent stem cells (iPS) and iPS-derived cell lines that are extracted ethically and have been characterized as per highest industry standards. Stem cell-derived cells iPS cells are derived from the skin fibroblasts from variety of healthy human donors of varying age and gender. These stem cell-derived cells are then commercialized for use with the consent obtained from cell donors. These stem cell-derived cells are then developed using a complete culture system that is an easy-to-use system used for defined iPS-derived cell expansion. Majority of the key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.
The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.
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The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:
Segmentation by Product Type
Segmentation by End User
The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.
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North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.
Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.
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The Stem Cell-Derived Cells Market to witness explicit growth from 2019 and 2029 - The Haitian-Caribbean News Network
Stem Cells Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the Competitors | (2020-2027),…
By daniellenierenberg
Stem Cells Market Overview:
Reports and Data has recently published a new research study titled Global Stem Cells Market that offers accurate insights for the Stem Cells market formulated with extensive research. The report explores the shifting focus observed in the market to offer the readers data and enable them to capitalize on market development. The report explores the essential industry data and generates a comprehensive document covering key geographies, technology developments, product types, applications, business verticals, sales network and distribution channels, and other key segments.
The global Stem Cells market is forecasted to grow at a rate of 8.4% from USD 9.35 billion in 2019 to USD 17.78 billion in 2027.
The report is further furnished with the latest market changes and trends owing to the global COVID-19 crisis. The report explores the impact of the crisis on the market and offers a comprehensive overview of the segments and sub-segments affected by the crisis. The study covers the present and future impact of the pandemic on the overall growth of the industry.
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Competitive Landscape:
The global Stem Cells market is consolidated owing to the existence of domestic and international manufacturers and vendors in the market. The prominent players of the key geographies are undertaking several business initiatives to gain a robust footing in the industry. These strategies include mergers and acquisitions, product launches, joint ventures, collaborations, partnerships, agreements, and government deals. These strategies assist them in carrying out product developments and technological advancements.
The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:
Thermo Fisher Scientific, Agilent Technologies, Illumina, Inc., Qiagen, Oxford Nanopore Technologies, Eurofins Scientific, F. Hoffmann-La Roche, Danaher Corporation, Bio-Rad Laboratories, and GE Healthcare.
An extensive analysis of the market dynamics, including a study of drivers, constraints, opportunities, risks, limitations, and threats have been studied in the report. The report offers region-centric data and analysis of the micro and macro-economic factors affecting the growth of the overall Stem Cells market. The report offers a comprehensive assessment of the growth prospects, market trends, revenue generation, product launches, and other strategic business initiatives to assist the readers in formulating smart investment and business strategies.
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Product Outlook (Revenue, USD Billion; 2017-2027)
Technology Outlook (Revenue, USD Billion; 2017-2027)
Therapy Outlook (Revenue, USD Billion; 2017-2027)
Application Outlook (Revenue, USD Billion; 2017-2027)
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Key Coverage in the Stem Cells Market Report:
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Stem Cells Market Research Provides an In-Depth Analysis on the Future Growth Prospects and Industry Trends Adopted by the Competitors | (2020-2027),...
Raleigh man delivers stem cells to patients around the world – WRAL.com
By daniellenierenberg
By Adam Owens, WRAL anchor/reporter
A 74-year-old Raleigh man spends an average of two weeks a month traveling around the world delivering stem cells or bone marrow to patients as part of Be The Match, a volunteer-based donor program.
According to Troy "Davis" Moore, Be The Match uses a database of 135 countries to find life-saving bone marrow or stem cells for patients with leukemia and other blood diseases. The stem cells are delivered from donors to patients around the world by volunteers like Moore.
Moore said, when he retired 17 years ago, gardening and working around the house just wasn't enough. His friend, who was already a volunteer courier with Be The Match, told him about the opportunity.
To date, Moore has logged more than 5,000 hours as a volunteer courier. He has traveled as far as London, Barcelona, Croatia, Portugal, Singapore and Taiwan.
On Thanksgiving week, Moore will travel to South America to pick up blood stem cells and deliver them to a patient in the United States. He had to get a rapid COVID-19 test before his trip.
"It's been a lot more challenging during COVID-19 because the rules have changed so much in these countries," said Moore, explaining he recently ran into some trouble in Croatia when he hadn't had a coronavirus test in 72 hours.
Moore said, although he doesn't get to meet the families he helps due to confidentiality, the job is incredibly special. In an interview with WRAL's Adam Owens, Moore described a trip he made on Christmas Day, 10 years ago, to deliver bone marrow from the United Kingdom to a hospital in Columbus, Ohio.
Moore said a nurse was walking him through the hospital hallways when she tapped on his shoulder and pointed to a patient room. Inside, he saw the parents of a child waiting for a transplant. "I have children and I could only imagine," Moore said. "They were just pacing down the room, waiting for it."
Moore said he plans to keep traveling until he can't anymore. Volunteering works well for him, he said, especially now that his children are grown.
Some people might get caught up in the adventure of travel, Moore said, but he's usually only in another country for one day.
"At some point, you realize that's not what it's all about," he said. "It's about getting [a cure] to someone."
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Raleigh man delivers stem cells to patients around the world - WRAL.com
St. Louis Native Heather Lynn Discusses Motivation for Donating Stem Cells – Ladue News
By daniellenierenberg
Since losing her cousin to leukemia during childhood, Heather Lynn made it her mission to ensure others battling blood cancers get a second chance at life. Earlier this year, the St. Louis native fulfilled that life purpose: saving a stranger by donating her stem cells.
Five years ago, Lynn became the director of global special events for DKMS, the worlds largest bone marrow and blood stem cell donor center, and registered as a potential donor with the hope that someday she could give a blood cancer patient what her cousin didnt have a second chance at life and more time with the patients family.
Amid this years coronaviral pandemic, Lynn received the life-changing call from a colleague that she was a match for a 58-year-old man battling acute myeloid leukemia. I screamed with joy, Lynn recalls. I was a match for someone with blood cancer and was about to be the first employee at DKMS to donate and ultimately save someones life. After the call, Lynn realized she would be giving more than stem cells: I was giving something much bigger: hope.
Despite the uncertainty surrounding COVID-19, Lynn felt a strong sense of purpose to help this man and donated her stem cells to save his life. I have seen how much someones life can change with a blood cancer diagnosis, Lynn says. The fear, the pain, the loss it can be devastating. I have spent the past five years working to elevate the message about donating and how easy it is to sign up and give back it simply requires swabbing the inside of each cheek for 60 seconds.
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St. Louis Native Heather Lynn Discusses Motivation for Donating Stem Cells - Ladue News
Actinium Highlights Foundational Patents Covering the Composition of Apamistamab Antibody and Iomab-B Antibody Radiation Conjugate for Targeted…
By daniellenierenberg
NEW YORK, Nov. 23, 2020 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today highlighted its intellectual property portfolio for apamistamab, a CD45 targeting antibody, and the Antibody Radiation Conjugate (ARC) comprised of apamistamab and the radioisotope iodine-131 used in the Company's lead Phase 3 candidate, Iomab-B, and its Iomab-ACT programs. Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer. Importantly, Actinium owns an issued patent in the US covering composition of matter, for which the Company expects validity until 2037.In addition, the Company owns a second issued US patent that further covers composition of matter, methods of use, and methods of administration for Iomab-B. The company has also received a notice of allowance in Europe for this second patent and expects it to be in force until 2036.
Iomab-B is currently being investigated in the ongoing pivotal Phase 3 SIERRA trial, which is over 75% enrolled, for targeted conditioning prior to potentially curative bone marrow transplant (BMT) for patients with relapsed or refractory Acute Myeloid Leukemia ("R/R AML"). In addition, Actinium is utilizing apamistamab with lower doses of iodine-131, known as Iomab-ACT, for targeted conditioning prior to gene therapy and adoptive cell therapy ("ACT"), namely CAR-T, including in its recently announced collaboration with Memorial Sloan Kettering Cancer Center that is supported by NIH STTR Fast Track grant funding.
"The continued protection of our lead asset Iomab-B, our Iomab-ACT program and apamistamab by a strong patent position is an important component of our development efforts, particularly as we approach the conclusion of our pivotal Phase 3 SIERRA trial for BMT conditioning in R/R AML The growth of BMT, ACT and Gene Therapy has highlighted the importance of conditioning and the need to move beyond non-targeted chemotherapy to increase the number of patients that could benefit from these potentially curative therapies.CD45 is an ideal target for conditioning applications given its unique expression on blood cancer cells and blood forming stem and immune cells and with no expression outside the hematopoietic or blood system," said Dr. Dale Ludwig, Actinium's Chief Scientific Officer. "Apamistamab is well characterized and its use in conditioning is supported by extensive clinical data across multiple clinical trials and indications. Our robust data shows that apamistamab has a favorable biodistribution profile that, together with our ARC technology, has significant advantages over other approaches such antibody drug conjugates that require payload internalization, making them impractical for targeting CD45.Further, our ARC approach allows us to use varying intensities of targeted radiation to achieve our desired conditioning outcome.With these important patents in place, and continued expansion of our patent portfolio in the US, EU and other select countries, we look forward to continuing to build out our targeted conditioning strategic business unit."
About Iomab-B
Iomab-B is Actinium's lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, apamistamab (formerly BC8), labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer and marrow cells. In a Phase 1/2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced enabled 100% of patients to proceed to transplant with all patients achieving transplant engraftment by day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, Hodgkin's disease, Non-Hodgkin lymphomas and multiple myeloma. Actinium obtained the worldwide, exclusive rights to apamistamab (BC8) and Iomab-B from the Fred Hutchinson Cancer Research Center. Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation.Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities.With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently.Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning.The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings.More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform.This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes.Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Contacts:
Investors:Clayton Robertson Actinium Pharmaceuticals, Inc. [emailprotected]
Hans VitzthumLifeSci Advisors, LLC[emailprotected](617) 430-7578
SOURCE Actinium Pharmaceuticals, Inc.
Adaptive Biotechnologies and Collaborators to Present Data from More Than 35 Abstracts at ASH 2020 Highlighting Clinical Relevance of MRD Testing with…
By daniellenierenberg
SEATTLE, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, together with its collaborators will present data from more than 35 abstracts studying the use of Adaptives clonoSEQ Assay for minimal residual disease (MRD) assessment at the American Society of Hematology (ASH) virtual 62nd Annual Meeting and Exposition, December 5-8. clonoSEQ is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in chronic lymphocytic leukemia (CLL), multiple myeloma and B-cell acute lymphoblastic leukemia (B-ALL) and is widely available to clinicians and patients across the U.S.
We are thrilled to see so many investigators presenting clonoSEQ data at ASH this year, among the more than 300 ASH studies highlighting MRD data, significantly growing the body of evidence validating this tool as a critical measure of patient outcomes, said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. As innovation continues for the treatment of blood cancers with novel and highly targeted therapies that create deep and durable responses for patients, we see clinicians increasingly utilizing clonoSEQ to help guide day-to-day patient care.
Assessment of MRD is a way to directly detect and quantify remaining disease, even in the absence of symptoms, across a spectrum of blood cancers. A patients MRD status gives clinicians timely information about how a patient may be responding to treatment, so patients and providers can be in control when it comes to managing their disease and treatment decisions.
clonoSEQ, the first clinical application of Adaptives immune medicine platform, will be featured in 14 oral presentations and 23 posters at ASH. Data on clinical and research utility from studies, as well as findings based on real-world experience, will be presented across a range of cancers including multiple myeloma, ALL, CLL and non-Hodgkins lymphoma (NHL). These new data show a correlation between clonoSEQ MRD results and improved blood cancer patient outcomes, enhanced clinical decision-making, and potential savings to the healthcare system.
Additional data at ASH this year will highlight Adaptives immune profiling research tool, immunoSEQ, to quantitatively assess the immune response to novel therapies in development.
Key presentations include:
AbouttheclonoSEQ AssayThe clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples.InAugust 2020, clonoSEQ received additional clearance from theFDA to detect and monitor MRD in blood or bone marrow from patients with CLL.
The clonoSEQ Assay leverages Adaptives proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL.
The clonoSEQ Assay is a single-site test performed at Adaptive Biotechnologies.In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visitwww.clonoSEQ.com/technical-summary.
About immunoSEQ Assay Adaptives immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, the immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures.
About AdaptiveAdaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is natures most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics and drug discovery. We have two commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.
For more information, please visit adaptivebiotech.com and follow us on http://www.twitter.com/adaptivebiotech.
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MEDIA CONTACT:Beth Keshishian917-912-7195media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina Calzadilla201-396-1687
Carrie Mendivil, Gilmartin Groupinvestors@adaptivebiotech.com
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Adaptive Biotechnologies and Collaborators to Present Data from More Than 35 Abstracts at ASH 2020 Highlighting Clinical Relevance of MRD Testing with...