REG - Hemogenyx Pharma Plc - Annual IND Report with FDA

Hemogenyx PharmaceuticalsAnnouncement

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RNS Number : 2900A  Hemogenyx Pharmaceuticals PLC  14 April 2026

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14 April 2026

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Hemogenyx Pharmaceuticals Files Annual IND Report with FDA for HG-CT-1 CAR-T
Therapy for AML

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that it has
submitted its Annual Report to the U.S. Food and Drug Administration (FDA)
under the active Investigational New Drug (IND) application for HG-CT-1, the
Company's proprietary CAR-T cell therapy for the treatment of relapsed or
refractory acute myeloid leukemia (R/R AML).

The annual report provides a comprehensive update on the Company's activities
under the IND during the second year of the clinical trial of HG-CT-1 and
includes the following key elements:

1.   Individual Study Information:

The ongoing Phase 1 study is designed to evaluate the safety and preliminary
efficacy of HG-CT-1 in adult and pediatric patients with R/R AML. The study
plans to enroll up to 36 evaluable subjects (18 adults and 18 pediatric
patients), with a primary objective of assessing safety based on dose-limiting
toxicities.

As of the IND anniversary date, three adult patients have been enrolled and
treated at the initial lowest dose level (7 × 10⁷ CAR(+) cells).

Across these patients:

·      CAR-T cell expansion and persistence were observed in all
subjects, with peak levels typically occurring between 14 and 28 days
post-infusion

·      Reductions in blast burden were observed in peripheral blood
and/or bone marrow

·      No immune effector cell-associated neurotoxicity syndrome (ICANS)
or dose-limiting toxicities (DLTs) were reported

·      Adverse events were generally low grade and manageable

These findings remain preliminary due to the limited number of patients and
evaluation at a single dose level.

2.   Quality Summary Information:

The report includes data from investigations conducted during the reporting
period relating to the stability of the HG-CT-1 drug product and its
lentiviral vector manufacturing process, supporting continued clinical
development.

3.   Update to the General Investigational Plan:

The Company plans to continue patient enrollment and dose escalation in the
upcoming year to further evaluate the safety profile and potential
anti-leukemic activity of HG-CT-1.

This filing marks another important step in the Company's clinical development
of HG-CT-1 and reaffirms its commitment to regulatory compliance and
transparent communication.

Further updates will be provided as the trial progresses.

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

"Submitting our second annual IND report to the FDA represents continued
progress in the development of HG-CT-1. While early-stage data remain
preliminary, we are encouraged by the observed biological activity and
manageable safety profile. We are focused on advancing the study through
additional dose levels to further evaluate the therapeutic potential of
HG-CT-1 for patients with relapsed or refractory AML."

 

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
 AlbR 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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