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Submission of IND for HEMO-CAR-T
Submission of IND for HEMO-CAR-T.
About this update from Hemogenyx Pharmaceuticals Plc
[{"type":"text","content":"\n\n9 May 2023\n \nHemogenyx Pharmaceuticals plc \n(\"Hemogenyx Pharmaceuticals\" or the \"Company\")\n \nSubmission of IND for HEMO-CAR-T\n \nHemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces the submission of an Investigational New Drug (\"IND\") application seeking authorization from the U.S. Food and Drug Administration (\"FDA\") to begin a Phase I clinical trial of its lead product candidate Chimeric Antigen Receptor (\"CAR\") T-cells (\"HEMO-CAR-T\") for treating acute myeloid leukemia (AML). This application follows the Company's successful work on manufacturability, quality, safety and other key parts of the development of HEMO-CAR-T. Once the clinical investigation plan proposed in the IND submission has been cleared to proceed by the FDA, the Company plans to initiate a Phase I clinical trial of HEMO-CAR-T.\nDr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: \"We are pleased to have reached this milestone with HEMO-CAR-T. We are committed to advancing therapies for blood diseases, and our work to address AML, which currently has poor survival rates, is an essential part of that commitment.\"\n \nAbout AML and CAR-T Therapy\nAML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML would have a major impact on treatment and survival rates for the disease.\nCAR-T therapy is a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.\n \nMarket Abuse Regulation (MAR) Disclosure\nThe information contained within this announcement is deemed to constitute inside information as stipulated under the Mar...