Hemogenyx Pharmaceuticals PLC HEMO-CAR-T 3rd Process Qualification Run Completed
23 Gennaio 2023 - 8:00AM
RNS Non-Regulatory
TIDMHEMO
Hemogenyx Pharmaceuticals PLC
23 January 2023
23 January 2023
RNS Reach - Non-Regulatory
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
HEMO-CAR-T Third 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
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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