Hemogenyx Pharmaceuticals Regulatory News (HEMO)

RNS Reach - Non-Regulatory

18 November 2022

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

HEMO-CAR-T Process Development Runs Completed

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for deadly blood diseases, is pleased to announce the successful completion of its second and final Process Development ("PD") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. The process was carried out in the Company's current Good Manufacturing Practice ("cGMP") compliant clean rooms.

This is another step for the Company in its preparation of the Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA") required to authorise commencement of Phase I clinical trials of HEMO-CAR-T. The Company's amazing team of scientists is now moving toward engineering runs (Process Qualification) of HEMO-CAR-T cell production.

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About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development.

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.