Hemogenyx Pharmaceuticals PLC HEMO-CAR-T First PQ Run Completed
12 Dicembre 2022 - 8:00AM
RNS Non-Regulatory
TIDMHEMO
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
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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