Hemogenyx Pharmaceuticals PLC Announces Tech Transfer Completion and Clinical Trial Update

Rhea-AI Summary

Hemogenyx Pharmaceuticals (OTC:HOPHF) announced on March 31, 2026 completion of the manufacturing tech transfer for HG-CT-1 to Made Scientific and submission of a comparability data package to the FDA. The company is ready to recruit adults at the second, increased dose and begin pediatric recruitment at the lowest dose level.

This expands the Phase 1 R/R AML program and confirms cross-site manufacturing reproducibility.

Positive

• Tech transfer completed to Made Scientific (CDMO)
• Comparability package submitted to FDA showing cross-site equivalence
• Adult recruitment ready for second, increased dose
• Clinical program expanding to pediatric R/R AML patients

Negative

• None.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL) ACT 2018, AS AMENDED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

LONDON, UK / ACCESS Newswire / March 31, 2026 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), a biopharmaceutical company focused on the development of innovative therapies for the treatment of blood diseases, is pleased to provide the following update on its HG-CT-1 CAR-T cell therapy program for relapsed/refractory acute myeloid leukemia (R/R AML):

Completion of Manufacturing Tech Transfer and FDA Submission

The Company announces that the technology transfer of the manufacturing process for its HG-CT-1 CAR-T cell therapy has been successfully completed to Made Scientific, a contract development and manufacturing organization (CDMO).

A comprehensive comparability data package has been submitted to the U.S. Food and Drug Administration (FDA). The submitted data demonstrate that HG-CT-1 manufactured by Made Scientific is comparable to that produced by Hemogenyx Pharmaceuticals, confirming the robustness and reproducibility of the manufacturing process across sites.

Clinical Trial Progression

Hemogenyx Pharmaceuticals is now ready to initiate recruitment of adult patients for treatment with the second, increased dose level of HG-CT-1 as part of its ongoing Phase 1 clinical trial in R/R AML.

In parallel, the Company will begin recruitment of pediatric patients, who will receive the lowest dose level of HG-CT-1. This marks an important expansion of the clinical program into pediatric populations suffering from R/R AML.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"We are pleased to have successfully completed the tech transfer of HG-CT-1 manufacturing and to have demonstrated comparability between internally and externally manufactured product. This is a critical milestone as we advance our clinical program.

With recruitment set to begin at the next dose level in adults and to expand into pediatric patients, we are well-positioned to accelerate the development of HG-CT-1 for patients with relapsed or refractory AML who have limited treatment options."

While the Company's efforts remain primarily focused on the HG-CT-1 clinical trials, it continues to advance its CDX and CBR product candidates where possible and expects to report further progress on these programmes in due course."

UK Market Abuse Regulation (UK 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
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
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.

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.

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 did Hemogenyx (HOPHF) announce about HG-CT-1 manufacturing on March 31, 2026?

They completed the manufacturing tech transfer to Made Scientific and submitted comparability data to FDA. According to the company, the submitted data show HG-CT-1 made by Made Scientific is comparable to product previously manufactured by Hemogenyx, supporting cross-site reproducibility.

Is Hemogenyx (HOPHF) recruiting adult patients for the HG-CT-1 Phase 1 trial?

Yes, adult recruitment will begin at the second, increased dose level. According to the company, the program is ready to initiate recruitment of adult patients for treatment at the next higher dose level in the ongoing Phase 1 R/R AML trial.

Will Hemogenyx (HOPHF) include children in the HG-CT-1 clinical program and at what dose?

Yes, pediatric recruitment will start at the lowest dose level. According to the company, pediatric patients with relapsed/refractory AML will be enrolled to receive the trial's lowest dose as the program expands into pediatric populations.

What does the FDA comparability submission mean for Hemogenyx (HOPHF)'s HG-CT-1 program?

It indicates manufacturing consistency between sites, supporting multi-site production. According to the company, the comparability package demonstrates HG-CT-1 made by the CDMO is comparable to internal manufacture, a key step for scaling clinical supply and trial expansion.

How does the March 31, 2026 update affect the HG-CT-1 Phase 1 timeline for Hemogenyx (HOPHF)?

The update enables dose-escalation and pediatric expansion in Phase 1, advancing clinical activity. According to the company, completing tech transfer and FDA submission positions the program to recruit adults at higher dose and begin pediatric enrollment promptly.