Hemogenyx says HEMO-CAR-T process qualification run completed

Shares of UK blood disease drug developer Hemogenyx Pharmaceuticals (LSE: HEMO) were down 7.5% at 2.13 pence as trading drew to a closed today, despite announcing 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 US 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.