REG - Hemogenyx Pharma Plc - Third Patient Safety

Hemogenyx PharmaceuticalsAnnouncement

17/09/2025 07:00

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RNS Number : 6032Z  Hemogenyx Pharmaceuticals PLC  17 September 2025

 

17 September 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

 

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

 

Hemogenyx Pharmaceuticals plc is pleased to announce that the third 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. Importantly, early indications of clinical efficacy have been
observed. Preliminary assessment shows that original AML cells were not
detectable in the patient using standard testing methods. The patient will
continue to be monitored in line with the FDA-approved trial protocol to
evaluate the achievement of the study's secondary endpoints described below.

Safety data from the first three patients treated at the lowest dose of
HG-CT-1 will be submitted to an independent Data Safety Monitoring Board
(DSMB) for review. The DSMB will determine whether dose escalation to the next
level may proceed.

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 third patient marks another important
milestone for Hemogenyx Pharmaceuticals and for patients battling relapsed or
refractory AML. We are encouraged by the favorable safety profile observed to
date, together with the early signals of efficacy. These results reinforce the
promise of HG-CT-1 as a potential new therapy for one of the most aggressive
and intractable forms of leukemia. We remain committed to advancing the
clinical development of this therapy to address a critical unmet medical need,
while also 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.

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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