REG - Hemogenyx Pharma Plc - Full FDA Review for HEMO-CAR-T IND

Hemogenyx PharmaceuticalsAnnouncement

10/07/2023 07:00

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RNS Number : 4200F  Hemogenyx Pharmaceuticals PLC  10 July 2023

 

10 July 2023

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Full FDA Review for HEMO-CAR-T IND

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group
developing new therapies and treatments for blood diseases, announces that the
Company has received a full review letter from the U.S. Food and Drug
Administration ("FDA") regarding the Investigational New Drug ("IND")
application for the Company's product candidate Chimeric Antigen Receptor
("CAR") T-cells ("HEMO-CAR-T") for the treatment of acute myeloid leukaemia
("AML") to the effect that HEMO-CAR-T be put on clinical hold ("CH"). The
letter contains a detailed description of the rationale for the decision to
put HEMO-CAR-T IND on CH. The reason for the CH relates to a splicing that
occurs during the manufacturing process of the lentivirus that is used to
produce CAR-T cells. The Company has identified the source of the splicing
deficiency and has already developed a method to eliminate it. The lentivirus
is being remanufactured. The CH letter also contains several suggestions on
how to improve the safety of HEMO-CAR-T. These suggestions do not and would
not contribute to the CH and can be dealt with readily.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented: "We are confident that we will be able to address the FDA's
questions and concerns regarding the IND. AML has poor survival rates and we
are eager to resolve this hold and continue down the treatment development
pathway toward saving lives."

 

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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