Hemogenyx Pharmaceuticals clears path to lifting FDA clinical hold
( ) , a biopharma company developing therapies and treatments for blood diseases, has successfully re-manufactured a splice variant-free lentivirus (LVV) for programming Chimeric Antigen Receptor T-cells (HEMO-CAR-T) to treat acute myeloid leukaemia.
The FDA previously imposed a clinical hold on Hemogenyx's Investigational New Drug (IND) application for the candidate, that was solely due to spontaneous splicing during LVV manufacturing. Before IND resubmission, Hemogenyx said it will perform an additional process qualification run using the new LVV, implementing this process as agreed with the FDA.
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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Acute myeloid leukemia (AML) is a type of blood and bone marrow cancer. Blood cancers affect over 1.1 million people in the US annually.
Currently, the most common treatment path is a BM/HSC transplant, but this comes with a string of disadvantages, including a high failure rate, with up to 50% of BM/HSC transplants failing due to the body’s rejection of the transplant and complications from the procedure or a relapse of the disease. On top of this, there is a shortage of BM/HSC donors, with 60% of donors unable to find a match.
Hemogenyx’s solution involves CAR-T therapy, a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognise and kill the patient's cancer cells. If successful, this therapy would have a major impact on treatment and survival rates of blood cancers.
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