Hemogenyx Pharmaceuticals PLC Announces Lentivirus Re-manufacturing Completed

Lentivirus Re-manufacturing Completed

LONDON, UK / ACCESSWIRE / November 15, 2023 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce the successful completion of the re-manufacturing of an improved lentivirus ("LVV") devoid of splice variants. The LVV is used to programme the Company's Chimeric Antigen Receptor ("CAR") T-cells ("HEMO-CAR-T") for the treatment of acute myeloid leukaemia ("AML"). Spontaneous splicing during the manufacturing of LVV was the only reason for the clinical hold imposed by the U.S. Food and Drug Administration ("FDA") on the Investigational New Drug ("IND") application for the Company's HEMO-CAR-T product candidate. As agreed with the FDA, before the resubmission of the IND, the Company will perform an additional process qualification run of the end-to-end process for the manufacture of HEMO-CAR-T cells using the new LVV and we will now put this process into effect.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased that we have a clear path to the lifting of the clinical hold. We are now working hard to complete the schedule of work set out in the plan presented and agreed to by the FDA and to re-submit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T."

About AML and CAR-T Therapy
AML, 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.

CAR-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.