Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T 3rd Process Qualification Run Completed

Rhea-AI Summary

Hemogenyx Pharmaceuticals plc has successfully completed its third Process Qualification run for the manufacturing of HEMO-CAR-T cells in cGMP compliant facilities. This achievement is crucial for the submission of an Investigational New Drug (IND) application to the FDA, required for initiating Phase I clinical trials. The company will conduct analytical release tests to ensure the quality of these cells, which will also be tested by a third party before the data is compiled for the IND submission.

Positive

• Successful completion of third Process Qualification run for HEMO-CAR-T cells.
• The process is compliant with Good Manufacturing Practice standards.
• Initiates next steps for FDA IND application, crucial for Phase I clinical trials.

Negative

• None.

LONDON, UK / ACCESSWIRE / January 23, 2023 / 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 third Process Qualification ("PQ") 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. It is being followed by analytical release tests conducted by the Company required to verify the quality of the manufactured HEMO-CAR-T cells. The HEMO-CAR-T cells will also be tested by a third party to ensure they comply with a set of required quality attributes.

This PQ run is the third of minimum three identical manufacturing runs required for the submission of an Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA"). The IND is needed to obtain authorization from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Following completion of all tests across all PQ runs, data will be compiled for inclusion in the IND submission pack.

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 platform technologies that it uses as engines for novel product development.

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SOURCE: Hemogenyx Pharmaceuticals PLC

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FAQ

What is the significance of the third Process Qualification run completed by HEMO?

The third Process Qualification run is essential for Hemogenyx Pharmaceuticals to move forward with their FDA IND application needed for Phase I clinical trials.

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

The IND application will be submitted after the completion of all required tests for the Process Qualification runs.

Which regulatory authority needs to approve the HEMO-CAR-T for clinical trials?

The U.S. Food and Drug Administration (FDA) must approve the HEMO-CAR-T cells for Phase I clinical trials.

What are the next steps after completing the Process Qualification run for HEMO-CAR-T?

After completing the Process Qualification run, Hemogenyx Pharmaceuticals will conduct quality tests and compile data for the IND submission to the FDA.