Last checked at 12 Dec 2022 07:00
12 December 2022
Reach - Non-Regulatory
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
HEMO-CAR-T First Process Qualification Run 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 first Process Qualification ("PQ") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run is one of a minimum of three identical manufacturing runs required for the submission of the Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA"). The process was carried out in the Company's current Good Manufacturing Practice ("cGMP") compliant clean rooms. It was followed by a battery of analytical release tests required to verify the quality of the manufactured HEMO-CAR-T cells.
This is another step for the Company in its preparation of the IND application to the FDA required to authorize commencement of Phase I clinical trials of HEMO-CAR-T.
Enquiries:
Hemogenyx Pharmaceuticals plc | https://hemogenyx.com |
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | headquarters@hemogenyx.com |
Peter Redmond, Director | peter.redmond@hemogenyx.com |
SP Angel Corporate Finance LLP | Tel: +44 (0)20 3470 0470 |
Matthew Johnson, Vadim Alexandre, Adam Cowl | |
Peterhouse Capital Limited | Tel: +44 (0)20 7469 0930 |
Lucy Williams, Duncan Vasey, Charles Goodfellow | |
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 a platform technology that it uses as an engine 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.