Hemogenyx lentivirus re-manufacturing completed
London-listed blood disease specialist Hemogenyx Pharmaceuticals (LSE: HEMO) has announced the successful completion of the re-manufacturing of an improved lentivirus (LVV) devoid of splice variants. The news saw the firm’s shares rise 4.9% to 2.70 pence in early trading
The LVV is used to program the company's chimeric antigen receptor (CAR) T-cells (HEMO-CAR-T) for the treatment of acute myeloid leukemia (AML). Spontaneous splicing during the manufacturing of LVV was the only reason for the clinical hold imposed by the US 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, Hemogenyx 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.
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