RE: Excitement builds20 May 2026 09:59
RNS dated: 31st March 2026
Moving forward You can all do the maths and work out what's going on, it's only a matter of days now.
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Tech Transfer Completion and Clinical Trial Progress
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
So all looking good ๐