REG - Hemogenyx Pharma Plc - First Patient Safety

Hemogenyx PharmaceuticalsAnnouncement

24/03/2025 07:00

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RNS Number : 8348B  Hemogenyx Pharmaceuticals PLC  24 March 2025

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF
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ABUSE (AMENDMENT) (EU EXIT) REGULATIIONS (SI 2019/310) ("UK MAR"). UPON THE
PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK
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24 March 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

First Patient Treated with HG-CT-1 CAR-T Therapy Passes Initial Safety Tests

Hemogenyx Pharmaceuticals plc is pleased to announce that the first patient
has been successfully treated as part of the Company's Phase I clinical trial
of HG-CT-1, the Company's proprietary CAR-T cell therapy for relapsed or
refractory acute myeloid leukemia (R/R AML) in adults. The treatment was well
tolerated, with no adverse effects observed, thereby passing the initial
safety assessment.

Early signs of efficacy are encouraging. The patient will continue to be
monitored in accordance with the FDA-approved clinical protocol to evaluate
whether the secondary endpoints of the trial are achieved.

Manufacturing of HG-CT-1 is currently underway for the treatment of a second
patient.

This Phase I clinical trial is a dose-escalation study designed to evaluate
the safety profile of HG-CT-1 in adult patients with R/R AML. In addition to
safety, key secondary objectives of the trial include:

·      Assessing the efficacy of HG-CT-1 based on AML-specific response
criteria

·      Evaluating overall survival

·      Measuring progression-free survival

·      Determining duration of response in patients demonstrating
clinical benefit

Data related to these secondary endpoints, including efficacy, durability, and
overall clinical outcomes, will be collected over time through continued
follow-up of the treated patient. These secondary endpoints are critical for
assessing the potential clinical impact of HG-CT-1 in a patient population
with limited remaining treatment options.

Further updates on the clinical trial will be provided in due course.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:
"The successful treatment of the first patient with HG-CT-1 marks a major
milestone not only for Hemogenyx Pharmaceuticals but also for patients
battling relapsed or refractory AML. We are encouraged by the favorable safety
profile observed so far and the early signs of efficacy. This outcome
strengthens our confidence in the potential of HG-CT-1 to address one of the
most challenging and deadly forms of leukemia. We remain committed to
advancing this therapy through clinical development with the goal of
delivering a transformative treatment to patients in desperate need while
creating long-term value for our shareholders."

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.

 

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 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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