REG - Hemogenyx Pharma Plc - HEMO-CAR-T Process Qualification Run Completed

Hemogenyx PharmaceuticalsAnnouncement

08/01/2024 07:00

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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
(https://www.londonstockexchange.com/news-article/HEMO/clinical-hold-on-ind-for-hemo-car-t/15983515)
. The FDA has accepted
(https://www.londonstockexchange.com/news-article/HEMO/clinical-hold-lift-plan-is-accepted-by-fda/16123495)
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 (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.

 

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