Hemogenyx Pharmaceuticals receives FDA nod for HEMO-CAR-T AML treatment study

Hemogenyx Pharmaceuticals plc, a London-based biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with its Phase I clinical study of HEMO-CAR-T, marking a significant milestone in the treatment of acute myeloid leukemia (AML). This development follows the FDA’s decision to lift the clinical hold on the Investigational New Drug (IND) application for HEMO-CAR-T, indicating that Hemogenyx Pharmaceuticals has satisfactorily addressed all concerns previously outlined by the agency.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, expressed his satisfaction with the FDA’s decision, highlighting the potential of HEMO-CAR-T to provide a life-saving treatment for patients with AML. This optimism is grounded in the rigorous work and dedication of the Hemogenyx Pharmaceuticals team, Board of Directors, and advisors, who together have navigated the challenges leading up to this approval. The move to accelerate the clinical development of HEMO-CAR-T is a beacon of hope for those affected by AML, a disease characterized by poor survival rates and limited treatment options.

AML stands as the most prevalent form of acute leukemia in adults, with survival statistics showing a grim five-year survival rate of less than 30%. Currently, chemotherapy is the primary treatment method, despite its limitations and side effects. The advancement of CAR-T therapy by Hemogenyx Pharmaceuticals promises a more effective and potentially less harmful alternative, leveraging the body’s own immune system to fight cancer.

CAR-T therapy, which involves modifying a patient’s T-cells to target and eliminate cancer cells, represents a frontier in personalized medicine. Hemogenyx Pharmaceuticals’ approach involves isolating T-cells from the patient, engineering them with a CAR gene construct to recognize cancer cells, amplifying these modified cells, and reintroducing them to the patient’s body. This innovative treatment could revolutionize the management of AML and other hematologic cancers.

With operations in both London and New York City, Hemogenyx Pharmaceuticals is at the forefront of developing new treatments for blood and autoimmune diseases. The company’s commitment to unlocking the curative power of bone marrow transplantation and advancing CAR-T therapy positions it as a leader in the biopharmaceutical industry, with the potential to transform the lives of patients suffering from incurable, life-threatening diseases.