Hemogenyx Pharmaceuticals PLC - HEMO-CAR-T First PQ Run Completed

Rhea-AI Summary

Hemogenyx Pharmaceuticals has successfully completed its first Process Qualification (PQ) run for the manufacture of HEMO-CAR-T cells, a crucial step in preparing for the Investigational New Drug (IND) application to the FDA. This PQ run is part of at least three required identical runs to facilitate the IND submission necessary for Phase I clinical trials. The process was executed in a cGMP-compliant environment, followed by quality verification tests on the manufactured cells, indicating readiness for further regulatory steps in the development of new therapies for blood diseases.

Positive

• Successful completion of the first Process Qualification run for HEMO-CAR-T cells.
• Preparation for IND application to the FDA, indicating progress toward Phase I clinical trials.
• Manufacturing process conducted in a cGMP-compliant facility, ensuring quality standards.

Negative

• None.

HEMO-CAR-T First Process Qualification Run Completed

LONDON, UK / ACCESSWIRE / December 12, 2022 / Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the "Company") (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.

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SOURCE: Hemogenyx Pharmaceuticals PLC

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FAQ

What does the completion of the first Process Qualification run for HEMO-CAR-T cells mean for Hemogenyx Pharmaceuticals?

The completion of the PQ run signifies a critical step toward filing the Investigational New Drug application with the FDA, which is essential for initiating Phase I clinical trials.

What are the next steps for Hemogenyx Pharmaceuticals after the Process Qualification run?

The company must conduct at least two more identical PQ runs before submitting the IND application to the FDA for HEMO-CAR-T cells.

How does the Process Qualification run affect HEMO stock (HOPHF)?

Successful completion of the PQ run can positively influence investor sentiment regarding HOPHF, as it shows progress in clinical development towards potentially life-saving therapies.

What is the significance of cGMP compliance in Hemogenyx Pharmaceuticals' manufacturing process?

cGMP compliance ensures that the manufacturing process meets stringent quality standards, which is crucial for the successful approval of drug applications by regulatory bodies like the FDA.