Healthcare Industry News: CAR T-cell therapy
News Release - December 1, 2020
Actinium Appoints Mary Mei Chen, M.D., Ph.D. as Vice President of Clinical DevelopmentDr. Chen brings over twenty years of clinical research and development experience; including executing global registrational trials in relapsed and refractory AML
NEW YORK, Dec. 1, 2020 -- (Healthcare Sales & Marketing Network) -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today announced the appointment of Mary Mei Chen, M.D., Ph.D. to the position of Vice President of Clinical Development, effective immediately. In this role, Dr. Chen will lead the clinical development of Actinium's CD33 program including the Actimab-A plus CLAG-M and Actimab-A plus venetoclax combination trials in relapsed and refractory Acute Myeloid Leukemia ("R/R AML"). Dr. Chen joins Actinium from GlycoMimetics, where she played a leading role in multiple clinical trials including the global pivotal Phase 3 study of uproleselan (GMI-1271-301). In addition to working on Actimab-A development, Dr. Chen will also utilize her training in immunology and experience in translational medicine to identify areas of synergy between targeted radiotherapy with Actimab-A and other therapeutic modalities.
Dr. Mark Berger, Actinium's Chief Medical Officer, said, "We are pleased to welcome Mary to our clinical development team as we are making major advances with our CD33 program and producing compelling data in our Actimab-A combination trials. Dr. Chen's most recent experience in executing a large global Phase 3 trial in R/R AML will be invaluable as we prepare for the next phase of our CD33 program where we strive to address the unmet needs of fit and unfit AML patients. Dr. Chen possesses an ideal skill set for this position, which includes her clinical hematology experience as well as extensive clinical development capabilities. In addition, Dr. Chen's immunology training and translational medicine experience prepare her well to identify and execute new combination trials with Actimab-A. Her experience will also translate well as we continue to investigate the synergistic potential of targeted radiotherapy with other therapeutic modalities."
Dr. Chen, added, "Despite several new therapeutic options, patients with AML still need better outcomes, particularly patients with relapsed or refractory disease. I was drawn to Actinium's targeted radiotherapy pipeline as it enables the precise delivery of radiation at a cellular level to blood cancer cells, which are highly sensitive to radiation. I believe this technology has tremendous potential in AML and other hematologic malignancies. The recent data from the Actimab-A combination trials with CLAG-M and venetoclax exemplify the potentiating and synergistic capabilities of targeted radiotherapy that I look forward to advancing in the clinic. In addition, I recognize the value of targeting radiation at specific cell types and the immunomodulating effects it can produce. I am excited to leverage my immunology and translational experiences to further bolster Actinium's R&D efforts to identify new combination trials and indications with ARCs in cancers other than hematologic malignancies."
Dr. Chen received training in both hematology (M.D.) and immunology (Ph.D.) followed by over twenty years of clinical research and development experience, including over ten years of biopharmaceutical industry experience and five years as a practicing hematologist. During her time in industry, she has led global, cross-functional teams in the design and execution of first-in-human clinical trials as well as trials in Phase 1 through Phase 3 in patients with AML, multiple myeloma, and breast cancer. She has contributed to the preparation and submission of regulatory documents and attended regulatory meetings to support Investigational New Drug (IND) and NDA applications in the US, EU, and other regions. Over the course of her career, she has authored over 50 peer reviewed publications in high impact journals. Dr. Chen joins Actinium from GlycoMimetics, Inc., where she led multiple clinical trials including the global pivotal Phase 3 study of uproleselan (GMI-1271-301), which is enrolling 380 patients with R/R AML at approximately 50 centers across nine countries. In this effort, Dr. Chen managed relationships with study investigators, created necessary protocols, Investigational Brochures, and target product profiles. Previously, Dr. Chen held the position of Medical Director, Global Clinical Lead–Clinical Science at Takeda Pharmaceuticals International where she developed clinical trials and protocols for T-cell and B-cell targeting therapies for oncology and inflammatory diseases. In this role, she successfully led multidisciplinary teams in the submission of an IND and Clinical Trial Application. Prior to Takeda, Dr. Chen worked at Pfizer (Wyeth), as Translational Medicine Team Lead-Translational Immunology. In this role, Dr. Chen supported biomarker development to support clinical development in hematology, oncology and inflammatory diseases for biologic and small molecules. At Pfizer, she contributed to the scientific, clinical and commercial development of the R&D pipeline and coordinated clinical development plans and protocols.
Prior to the biopharmaceutical industry, Dr. Chen was a researcher at the Harvard Medical School, Brigham and Women's Hospital in the Department of Immunology, Rheumatology and Allergy, initially as a Postdoctoral Fellow before becoming Faculty Member, Instructor in Medicine. Mary received her Ph.D. in Immunology from Chiba University, Graduate School of Medicine in Tokyo, Japan. She completed her postdoctoral fellowship in the department of infection and host disease at Chiba University. Dr. Chen received her Doctor of Medicine degree from Shanghai Jiao Tong University, School of Medicine.
About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)
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 with Memorial Sloan Kettering Cancer Center 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.
Source: Actinium Pharmaceuticals
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