REG - Hemogenyx Pharma Plc - Submission of IND for HEMO-CAR-T

Hemogenyx PharmaceuticalsAnnouncement

09/05/2023 07:15

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RNS Number : 6705Y  Hemogenyx Pharmaceuticals PLC  09 May 2023

9 May 2023

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Submission of IND for HEMO-CAR-T

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group
developing new therapies and treatments for blood diseases, announces the
submission of an Investigational New Drug ("IND") application seeking
authorization from the U.S. Food and Drug Administration ("FDA") to begin a
Phase I clinical trial of its lead product candidate Chimeric Antigen Receptor
("CAR") T-cells ("HEMO-CAR-T") for treating acute myeloid leukemia (AML). This
application follows the Company's successful work on manufacturability,
quality, safety and other key parts of the development of HEMO-CAR-T. Once the
clinical investigation plan proposed in the IND submission has been cleared to
proceed by the FDA, the Company plans to initiate a Phase I clinical trial of
HEMO-CAR-T.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented: "We are pleased to have reached this milestone with HEMO-CAR-T. We
are committed to advancing therapies for blood diseases, and our work to
address AML, which currently has poor survival rates, is an essential part of
that commitment."

 

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

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulation ("MAR")
(EU) No. 596/2014, as incorporated into UK law by the European Union
(Withdrawal) Act 2018. Upon the publication of this announcement, this inside
information is now considered to be in the public domain.

 

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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