Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T Process Development Runs Completed

Rhea-AI Summary

Hemogenyx Pharmaceuticals plc has successfully completed its second and final Process Development run for HEMO-CAR-T cell manufacturing in cGMP-compliant facilities. This advancement is a crucial step towards submitting the Investigational New Drug application to the FDA for initiating Phase I clinical trials of HEMO-CAR-T. The company is now preparing for engineering runs as part of its Process Qualification phase. Hemogenyx focuses on developing innovative therapies for serious blood diseases and aims to enhance patient access to life-saving bone marrow transplants.

Positive

• Successful completion of the second and final Process Development run for HEMO-CAR-T cells.
• Preparation for Investigational New Drug application to the FDA for Phase I clinical trials.

Negative

• None.

LONDON, UK / ACCESSWIRE / November 18, 2022 / 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.

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 Matthew Johnson, Vadim Alexandre, Adam Cowl	Tel: +44 (0)20 3470 0470
Peterhouse Capital Limited Lucy Williams, Duncan Vasey, Charles Goodfellow	Tel: +44 (0)20 7469 0930

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.

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SOURCE: Hemogenyx Pharmaceuticals PLC

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FAQ

What progress has Hemogenyx Pharmaceuticals made in the HEMO-CAR-T project?

Hemogenyx Pharmaceuticals has completed its second and final Process Development run for HEMO-CAR-T cells, moving closer to FDA approval for clinical trials.

When will Hemogenyx Pharmaceuticals submit its IND application for HEMO-CAR-T?

The company is preparing to submit the Investigational New Drug application to the FDA as part of its readiness for Phase I clinical trials.

What is the significance of the successful Process Development run for HEMO-CAR-T?

The successful run is a critical step toward advancing Hemogenyx Pharmaceuticals' efforts in developing therapies for serious blood diseases.

What are the next steps for Hemogenyx Pharmaceuticals after the recent development run?

The next steps include conducting engineering runs as part of the Process Qualification for HEMO-CAR-T cell production.

How does Hemogenyx Pharmaceuticals' work impact patients with blood diseases?

The company's technology aims to increase access to curative bone marrow transplants for patients suffering from severe blood diseases.