30 December 2024

Hemogenyx Pharmaceuticals plc 

("Hemogenyx Pharmaceuticals" or the "Company")

Hemogenyx Pharmaceuticals Opens First Clinical Site for HG-CT-1 Phase I Trial

Patient Recruitment Begins for CAR-T Cell Therapy Targeting Relapsed/Refractory Acute Myeloid Leukemia in Adults

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce the opening of the first clinical site for its lead asset, HG-CT-1, targeting relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults. Recruitment of patients for the trials has begun.

This Phase I trial is designed as a dose-escalation study to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML. Key secondary objectives include assessing the therapy's impact on the following clinical outcomes:

·      Efficacy of HG-CT-1 based on AML-specific response criteria

·      Overall survival (OS) rates among participating subjects

·      Progression-free survival (PFS) in evaluable subjects

·      Duration of response (DoR) in those who achieve clinical responses.

These objectives are pivotal for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options. The commencement of this trial represents a major milestone for Hemogenyx Pharmaceuticals, enabling the Company to advance this promising therapy into clinical testing at one of the world's most prestigious cancer research institutions.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
" The opening of our first clinical site for the Phase I trial of HG-CT-1 is a milestone in our mission to revolutionize the treatment landscape for relapsed and refractory acute myeloid leukemia. This trial offers hope to patients who currently face limited treatment options by exploring the safety and potential efficacy of HG-CT-1. We are excited to start this pivotal study."

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 forms 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.

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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 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.