Hemogenyx Pharmaceuticals PLC HEMO-CAR-T Analytical Release Tests Completed
March 23 2023 - 9:32AM
RNS Non-Regulatory
TIDMHEMO
Hemogenyx Pharmaceuticals PLC
23 March 2023
23 March 2023
RNS Reach - Non-Regulatory
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
HEMO-CAR-T Analytical Release Tests 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 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.
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