REG - Hemogenyx Pharma Plc - Third Patient Treated with HG-CT-1 CAR-T Therapy

Hemogenyx PharmaceuticalsAnnouncement

15/08/2025 07:00

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RNS Number : 4320V  Hemogenyx Pharmaceuticals PLC  15 August 2025

 

15 August 2025

 

Hemogenyx Pharmaceuticals plc

 

("Hemogenyx Pharmaceuticals" or the "Company")

 

Third Patient Treated with HG-CT-1 CAR-T Therapy and Completion of First Adult
Dose Cohort

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that the
third patient has been successfully treated as part of the Company's ongoing
Phase I clinical trial of HG-CT-1, its proprietary CAR-T cell therapy for
relapsed or refractory acute myeloid leukemia ("R/R AML") in adults.

Treatment of this patient, the final participant in the first adult dose
cohort, was made possible after the Company secured special permission from
the U.S. Food and Drug Administration (FDA) to proceed under exceptional
circumstances. This regulatory clearance reflects the Company's ability to
navigate complex clinical challenges to ensure eligible patients can access
potentially life-saving therapies.

Completion of the first adult dose cohort, which received the lowest dose of
HG-CT-1, represents a pivotal milestone in the Company's trial. If no
dose-limiting toxicities are observed, Hemogenyx Pharmaceuticals will:

·      Advance to the second adult dose cohort at twice the initial
dose, and

·      Initiate recruitment for the pediatric arm of the trial,
addressing a critical unmet need in childhood AML.

The Phase I trial is a dose-escalation study designed to assess safety and
collect data on key secondary endpoints, including anti-leukemic activity,
overall survival, progression-free survival, and duration of response. The
Company is pleased to report that the first two patients treated with HG-CT-1
remain alive at six months and three months post-treatment, respectively.

 

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:

"Completing the first adult dose cohort is a major achievement in our Phase I
trial of HG-CT-1. I am proud of our team's persistence in working with the FDA
to obtain the necessary clearance to treat this patient. With this milestone
reached, we are well positioned to move into the higher-dose cohort and to
open our pediatric arm, advancing our mission to deliver transformative
therapies for AML patients of all ages."

 

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.

 

 

 

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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