RCS - Hemogenyx Pharma Plc - FDA Annual Report

Hemogenyx PharmaceuticalsAnnouncement

03/04/2025 07:00

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RNS Number : 4304D  Hemogenyx Pharmaceuticals PLC  03 April 2025

3 April 2025

 

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 first year of the clinical trial of HG-CT-1 and
includes the following key elements:

1.   Individual Study Information:

A summary of the ongoing clinical study, including its title, design, purpose
and objectives, patient population, the total number of planned subjects, and
the number enrolled as of the IND anniversary date (February 6, 2025). The
report confirms the enrollment of the first patient and includes demographic
details such as age, sex, and race.

2.   Quality Summary Information:

Data obtained from the past year's investigations under the IND related to the
stability of the HG-CT-1 drug product and the lentiviral vector used in its
manufacturing.

3.   Update to the General Investigational Plan:

A forward-looking update outlining the plan for continued patient enrollment
during the upcoming year of the study.

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 with stakeholders.

Further updates will be provided as the trial progresses.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:
"Submitting our first annual IND report to the FDA is an important milestone
that underscores the steady progress we are making in the clinical development
of HG-CT-1. For patients facing relapsed or refractory AML, it brings us one
step closer to delivering a potentially life-saving therapy. For our investors
and partners, it demonstrates our continued execution, scientific rigor, and
commitment to transparency. We are advancing with purpose and precision-guided
by the urgency of patient need and the confidence of our supporters."

 

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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