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Hemogenyx Pharmaceuticals PLC Announces Manufacturing Partnership with Made Scientific

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Hemogenyx Pharmaceuticals (HOPHF) has announced a strategic manufacturing partnership with Made Scientific to advance its HG-CT-1 CAR-T therapy for relapsed/refractory acute myeloid leukemia (r/r AML) in adults. The collaboration will utilize Made Scientific's GMP facilities in Newark and Princeton, NJ, for both clinical and commercial supply of cell therapies.

The partnership aims to accelerate Hemogenyx's ongoing Phase I clinical trial of HG-CT-1 and potentially expand to include pediatric r/r AML patients. Early clinical data has shown promising results in both safety and potential efficacy. Made Scientific will provide specialized expertise in CAR-T cell therapy technology transfer and manufacturing support.

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Positive

  • Early clinical data shows promising safety and efficacy results for HG-CT-1 therapy
  • Partnership provides access to GMP-certified manufacturing facilities for both clinical and commercial supply
  • Potential expansion of trial to include pediatric patients indicates broader market opportunity
  • Manufacturing collaboration could accelerate ongoing Phase I clinical trial progress

Negative

  • Manufacturing partnership suggests significant capital requirements for therapy development
  • Early-stage Phase I status indicates long pathway to potential commercialization

Hemogenyx Pharmaceuticals Announces Manufacturing Partnership with Made Scientific to Advance HG-CT-1 CAR-T Therapy

CITY OF LONDON, GB / ACCESS Newswire / September 8, 2025 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), is pleased to announce a manufacturing partnership with Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), to advance HG-CT-1, the Company's autologous Chimeric Antigen Receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML) in adults.

Under the agreement, Hemogenyx Pharmaceuticals will leverage Made Scientific's specialized expertise in CAR-T cell therapy technology transfer and manufacturing at its GMP facilities in Newark and Princeton, NJ, which are equipped for both clinical and commercial supply of cell therapies. The collaboration is expected to accelerate Company's ongoing Phase I clinical trial of HG-CT-1 in adult patients and to support the potential inclusion of additional cohorts for pediatric r/r AML patients.

The Company has already made significant progress in the trial, with early clinical data supporting growing confidence in both safety and potential efficacy.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"Partnering with a trusted CDMO like Made Scientific is essential to the success of HG-CT-1, our lead CAR-T therapy. Made's expertise in cell therapy manufacturing will be instrumental in driving the continued progress of this potentially breakthrough therapy for patients with relapsed or refractory AML, fully in line with our identity as a life saving company."

Syed T. Husain, Chairman & CEO of Made Scientific, said:
"Our collaboration with Hemogenyx Pharmaceuticals reflects Made Scientific's commitment to advancing next-generation cell therapies that address urgent, unmet medical needs. Through our integrated development and manufacturing solutions and highly experienced team, we are proud to support Hemogenyx Pharmaceuticals as they advance HG-CT-1 in their Phase I clinical trial."

Enquiries:

Hemogenyx Pharmaceuticals plc

https://hemogenyx.com

Dr Vladislav Sandler, Chief Executive Officer & Co-Founder

headquarters@hemogenyx.com

Peter Redmond, Director

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.

About Made Scientific
Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

SOURCE: Hemogenyx Pharmaceuticals PLC



View the original press release on ACCESS Newswire

FAQ

What is the purpose of Hemogenyx's (HOPHF) partnership with Made Scientific?

The partnership aims to advance HG-CT-1, Hemogenyx's CAR-T therapy for relapsed/refractory acute myeloid leukemia, by leveraging Made Scientific's specialized expertise in CAR-T cell therapy manufacturing and GMP facilities.

What stage is Hemogenyx's (HOPHF) HG-CT-1 therapy currently in?

HG-CT-1 is currently in Phase I clinical trials for adult patients with relapsed/refractory AML, with early data showing promising safety and efficacy results.

Where will Made Scientific manufacture Hemogenyx's (HOPHF) CAR-T therapy?

Manufacturing will take place at Made Scientific's GMP facilities in Newark and Princeton, NJ, which are equipped for both clinical and commercial supply of cell therapies.

What are the potential expansion plans for Hemogenyx's (HOPHF) HG-CT-1 therapy?

The company is considering expanding the trial to include additional cohorts for pediatric r/r AML patients, broadening the potential patient population.

Who is leading Hemogenyx Pharmaceuticals (HOPHF)?

Dr. Vladislav Sandler serves as the CEO and Co-Founder of Hemogenyx Pharmaceuticals.
Hemogenyx Pharma

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