RCS - Hemogenyx Pharma Plc - HEMO-CAR-T Process Qualification Run Completed

Hemogenyx PharmaceuticalsAnnouncement

04/01/2023 07:00

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RNS Number : 5608L  Hemogenyx Pharmaceuticals PLC  04 January 2023

4 January 2023

 

RNS Reach - Non-Regulatory

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

HEMO-CAR-T Second 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 second 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 was followed by a battery of
analytical release tests required to verify the quality of the manufactured
HEMO-CAR-T cells.

 

This PQ run is the second 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.

 

Enquiries:

 

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         peter.redmond@hemogenyx.com (mailto: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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