Hemogenyx Pharmaceuticals PLC Announces HEMO-CAR-T Analytical Release Tests Completed

Rhea-AI Summary

Hemogenyx Pharmaceuticals has announced the successful completion of analytical tests for its HEMO-CAR-T production across three Process Qualification (PQ) runs. These PQ runs, conducted in cGMP compliant facilities, are crucial for ensuring the quality of the manufactured cells, focusing on attributes like viability, potency, and sterility. This achievement fulfills the last manufacturing requirement for submitting an Investigational New Drug (IND) application to the FDA, which is currently being prepared. The IND is necessary to initiate Phase I clinical trials for HEMO-CAR-T, marking a significant step forward in the Company's development of new therapies for blood diseases.

Positive

• Completion of analytical tests for HEMO-CAR-T production is a major milestone.
• Successful PQ runs indicate high-quality manufacturing processes.
• Preparation of IND application signals progress towards Phase I clinical trials.

Negative

• None.

LONDON, UK / ACCESSWIRE / March 23, 2023 / 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 a full set of analytical tests required to verify the quality of the cells manufactured during three Process Qualification ("PQ") runs of the end-to-end process for HEMO-CAR-T production. Each PQ run is an end-to-end process of the manufacture of HEMO-CAR-T cells. The PQ runs were carried out in the Company's current Good Manufacturing Practice ("cGMP") compliant clean rooms. They were followed by analytical release tests that were conducted both by the Company and a third party to ensure that manufactured HEMO-CAR-T cells comply with a set of required quality attributes. Among these attributes are viability, potency and sterility of the manufactured HEMO-CAR-T cells.

The completion of the full set of analytical tests of all PQ runs is the last manufacturing requirement that is necessary for the submission of an Investigational New Drug ("IND") application to the US Food and Drug Administration ("FDA"), which is now in the course of preparation. The IND is needed to obtain authorization from the FDA to commence Phase I clinical trials of HEMO-CAR-T. All PQ runs as well as analytical tests 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.

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

SOURCE: Hemogenyx Pharmaceuticals PLC

View source version on accesswire.com:
https://www.accesswire.com/745428/Hemogenyx-Pharmaceuticals-PLC-Announces-HEMO-CAR-T-Analytical-Release-Tests-Completed

FAQ

What is the significance of the analytical tests completed by Hemogenyx Pharmaceuticals on March 23, 2023?

The completed analytical tests are critical for ensuring the quality of HEMO-CAR-T cells, fulfilling the requirements for the IND application to the FDA to start Phase I clinical trials.

How does the completion of Process Qualification runs impact Hemogenyx Pharmaceuticals' future?

The completion of Process Qualification runs positions Hemogenyx Pharmaceuticals to submit the IND application, a crucial step for advancing its HEMO-CAR-T therapy into clinical trials.

What are the next steps for Hemogenyx Pharmaceuticals after the successful PQ runs?

Following the successful PQ runs, Hemogenyx Pharmaceuticals is preparing to submit its IND application to the FDA for HEMO-CAR-T clinical trials.

What attributes are evaluated in the analytical tests for HEMO-CAR-T cells?

The analytical tests evaluate vital attributes such as viability, potency, and sterility of the manufactured HEMO-CAR-T cells.