Hemogenyx Pharmaceuticals(HEMO) , a biopharma company developing therapies and treatments for blood diseases, said the FDA has accepted its plan to address the FDA's concerns that resulted in a Clinical Hold of the HEMO-CAR-T Investigational New Drug application.
Following the FDA's feedback in July 2023, Hemogenyx Pharmaceuticals responded in August 2023 with a comprehensive plan supported by laboratory tests. The FDA has now confirmed that the plan effectively addresses their concerns.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are pleased that the FDA has agreed to our plan and preliminary test results to address their concerns regarding our HEMO-CAR-T IND application. We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as possible in order to move forward with clinical trials of HEMO-CAR-T."
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When it reaches the market, Hemogenyx’s HEMO-CAR-T will be used to treat acute myeloid leukemia (AML) which 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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