HEMO-CAR-T Process Qualification Run Completed

Hemogenyx Pharmaceuticals plc (LSE: HEMO), which is developing new therapies and treatments for blood diseases, is pleased to announce the successful completion of its Process Qualification ("PQ") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run was a part of the Company's plan to address the U.S. Food and Drug Administration ("FDA") concerns that resulted in a Clinical Hold ("CH") of the HEMO-CAR-T Investigational New Drug ("IND") application, as announced previously. The FDA has accepted the Company's plan.

The process was carried out in the Company's current Good Manufacturing Practice compliant clean rooms. It was followed by analytical release tests conducted by the Company required to verify the quality of the manufactured HEMO-CAR-T cells. The HEMO-CAR-T cells are also being tested by a third party to ensure they comply with a set of required quality attributes.

This PQ run is the only manufacturing run required for the submission of a complete response to the CH of the IND application to the FDA for HEMO-CAR-T. It was the key remaining step prior to applying for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Following the successful completion of all tests across the PQ run, data will be compiled for inclusion in the complete response submission pack.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased that we have now completed the necessary PQ run. We are now working hard to re-submit the IND as expeditiously as possible to move forward with clinical trials of HEMO-CAR-T."

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