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Hemogenyx Pharmaceuticals PLC on Wednesday said it has completed the re-manufacturing of an improved lentivirus devoid of splice variants. The London-based biopharmaceutical company focused on treatments for deadly blood diseases said the virus will be used to programme its Chimeroc Antigen Receptor T-cellsto treat acute myeloid leukemia. The company noted that spontaneous splicing during previous manufacturing of the virus was the reason for the US Food & Drug Administration’s clinical hold on its Investigational New Drug application. The firm noted that prior to the resubmission of the application, it has agreed to undertake an additional process qualification run of the manufacture of the HEMOCAR-T cells using the new virus. Chief Executive Vladislav Sandler said: ‘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.’ Hemogenyx shares fell 4.1% to 2.47 pence each on Wednesday afternoon in London. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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