REG - Hemogenyx Pharma Plc - Second Patient Passes Initial Safety Tests

Hemogenyx PharmaceuticalsAnnouncement

03/06/2025 07:00

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RNS Number : 1126L  Hemogenyx Pharmaceuticals PLC  03 June 2025

 

3 June 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

 

Second Patient Treated with HG-CT-1 CAR-T Therapy Successfully Passes Initial
Safety Evaluation

 

Hemogenyx Pharmaceuticals plc is pleased to announce that the second patient
has been successfully treated in the ongoing Phase I clinical trial of
HG-CT-1, the Company's proprietary Chimeric Antigen Receptor T-cell (CAR-T)
therapy for relapsed/refractory acute myeloid leukemia (R/R AML) in adults.

The treatment was well tolerated and met the trial's predefined initial safety
criteria. Encouragingly, early indications of clinical efficacy are evident.
The patient will continue to be monitored according to the FDA-approved trial
protocol to assess whether the study's secondary endpoints are achieved.

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

The Phase I trial is a dose-escalation study designed to evaluate the safety
and tolerability of HG-CT-1. In addition to safety, the trial includes several
key secondary endpoints:

·      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 will be provided as the trial progresses.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:
"The successful treatment of the second patient represents a meaningful step
forward for both Hemogenyx and for patients battling relapsed or refractory
AML. We are encouraged by the favorable safety profile observed to date and by
the early signs of efficacy. These results further validate the promise of
HG-CT-1 as a novel treatment for one of the most aggressive and intractable
forms of leukemia. We remain focused on advancing the clinical development of
this therapy to address a critical unmet need, while also building 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 diseases. Hemogenyx
Pharmaceuticals is developing several distinct and complementary product
candidates, as well as platform technologies that it uses as engines for novel
product development.

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