Hemogenyx Pharmaceuticals PLC HEMO-CAR-T Process Qualification Run Completed (8683Y)
January 08 2024 - 1:00AM
UK Regulatory
TIDMHEMO
RNS Number : 8683Y
Hemogenyx Pharmaceuticals PLC
08 January 2024
8 January 2024
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
HEMO-CAR-T Process Qualification Run Completed
Hemogenyx Pharmaceuticals plc (LSE: HEMO), which is developing
new therapies and treatments for blood diseases, is pleased to
announce the successful completion of its Process Qualification
("PQ") run of the end-to-end process for the manufacture of
HEMO-CAR-T cells. This PQ run was a part of the Company's plan to
address the U.S. Food and Drug Administration ("FDA") concerns that
resulted in a Clinical Hold ("CH") of the HEMO-CAR-T
Investigational New Drug ("IND") application, as announced
previously . The FDA has accepted the Company's plan.
The process was carried out in the Company's current Good
Manufacturing Practice compliant clean rooms. It was 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 are also being tested by a third party to ensure
they comply with a set of required quality attributes.
This PQ run is the only manufacturing run required for the
submission of a complete response to the CH of the IND application
to the FDA for HEMO-CAR-T . It was the key remaining step prior to
applying for the lifting of the CH which is needed to obtain
consent from the FDA to commence Phase I clinical trials of
HEMO-CAR-T. Following the successful completion of all tests across
the PQ run, data will be compiled for inclusion in the complete
response submission pack.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: "We are pleased that we have now
completed the necessary PQ run. We are now working hard to
re-submit the IND as expeditiously as possible to move forward with
clinical trials of HEMO-CAR-T."
About AML and CAR-T Therapy
AML, the most common type of acute leukemia in adults, has poor
survival rates (a five-year survival rate of less than 30% in
adults) and is currently treated using chemotherapy, rather than
the potentially more benign and effective form of therapy being
developed by Hemogenyx Pharmaceuticals. The successful development
of a new therapy for AML would have a major impact on treatment and
survival rates for the disease.
CAR-T therapy is a treatment in which a patient's own T-cells, a
type of immune cell, are modified to recognize and kill the
patient's cancer cells. The procedure involves: isolating T-cells
from the patient; modifying the isolated T-cells in a laboratory
using a CAR gene construct (which allows the cells to recognize the
patient's cancer); amplifying (growing to large numbers) the newly
modified cells; and re-introducing the cells back into the
patient.
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have
been inside information for the purposes of Article 7 of Regulation
No 596/2014 (as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018) until the release of this
announcement. The person responsible for arranging for the release
of this announcement on behalf of Hemogenyx Pharmaceuticals plc is
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.
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
Tel: +44 (0)20 3470
SP Angel Corporate Finance LLP 0470
Matthew Johnson, Vadim Alexandre,
Adam Cowl
Tel: +44 (0)20 7469
Peterhouse Capital Limited 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.
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