RCS - Hemogenyx Pharma Plc - HEMO-CAR-T First PQ Run Completed

Hemogenyx PharmaceuticalsAnnouncement

12/12/2022 07:00

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RNS Number : 2937J  Hemogenyx Pharmaceuticals PLC  12 December 2022

12 December 2022

 

Reach - Non-Regulatory

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

HEMO-CAR-T First 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 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 (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 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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