Lentivirus Re-manufacturing Completed

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce the successful completion of the re-manufacturing of an improved lentivirus ("LVV") devoid of splice variants. The LVV is used to programme the Company's Chimeric Antigen Receptor ("CAR") T-cells ("HEMO-CAR-T") for the treatment of acute myeloid leukaemia ("AML"). Spontaneous splicing during the manufacturing of LVV was the only reason for the clinical hold imposed by the U.S. Food and Drug Administration ("FDA") on the Investigational New Drug ("IND") application for the Company's HEMO-CAR-T product candidate. As agreed with the FDA, before the resubmission of the IND, the Company will perform an additional process qualification run of the end-to-end process for the manufacture of HEMO-CAR-T cells using the new LVV and we will now put this process into effect.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased that we have a clear path to the lifting of the clinical hold. We are now working hard to complete the schedule of work set out in the plan presented and agreed to by the FDA and to re-submit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T."

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