Genesis Biopharma, Inc., a biopharmaceutical company that engages in the development and commercialization of drugs and other clinical solutions for underserved diseases, announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Under the terms of the five-year development and cooperative research agreement, Genesis Biopharma will be working with Steven A. Rosenburg, M.D., Ph.D., the NCI Surgery Branch Chief, in order to develop adoptive cell immunotherapies that are created to destroy metastatic melanoma cells utilizing a patient’s tumor infiltrating lymphocytes.
More specifically, the CRADA will (i) provide support to the in vitro development of improved methods to generate and select tumor infiltrating lymphocytes with anti-tumor reactivity from patients with metastatic melanoma, (ii) help develop an approach for a larger-scale production of tumor infiltrating lymphocytes in accordance with Good Manufacturing Practice (GMP) procedures that are suitable for use in treating patients that suffer from metastatic melanoma, and (iii) allow the conduct of clinical trials by utilizing these improved methods of generating tumor infiltrating lymphocytes, as well as the improved adoptive cell therapy preparative regimens used to treat patients with metastatic melanoma.
Both Genesis Biopharma and the NCI may offer personnel, facilities, services, equipment, or other resources with the agreement. Genesis Biopharma will provide funding for the CRADA research project. Genesis Biopharma will have an exclusive opportunity to negotiate an exclusive license to any new inventions that are developed jointly or entirely by NCI scientists as a result of the research activities described under the CRADA.
“The medical oncology community is very aware of Dr. Rosenberg’s groundbreaking work using adoptive cell therapy and tumor infiltrating lymphocytes for the treatment of metastatic melanoma,” stated Anthony J. Cataldo, Chairman and Chief Executive Officer of Genesis Biopharma. “We look forward to working with Dr. Rosenberg and his colleagues at the NCI on this research project.”
Genesis Biopharma has been independently working on developing Contego™, the Company’s autologous cell therapy candidate used for the treatment of metastatic melanoma, and has partnered with members of its Scientific and Medical Advisory Board for assistance and advice. Genesis Biopharma’s Scientific and Medical Advisory Board consists of leading oncology clinicians and researchers, including: David DiGiusto, Ph.D., of the City of Hope; Mario Sznol, M.D., of Yale University School of Medicine; James Mule, Ph.D. and Jeffrey Weber, M.D., Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute; Daniel Powell, Ph.D., of the University of Pennsylvania School of Medicine; Cassian Yee, M.D., of the Fred Hutchinson Cancer Research Center; and James Mule, Ph.D. and Jeffrey Weber, M.D., Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute.
Genesis Biopharma has also recently announced that it has signed a process development and scale-up agreement relating to the manufacturing of Contego with Lonza, one of the world’s leading supplier for the healthcare, life science, and pharmaceutical industries. Lonza is also one of the biggest manufacturers of autologous cell therapy products.
For more information on Genesis Biopharma, Inc., visit their company website at www.genesis-biopharma.com
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