Penn spinout Carisma Therapeutics received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). This novel CAR-M approach has the potential to address the challenges of treating solid tumors with cell therapies.
Having received a Study May Proceed notification from the FDA, Carisma plans to initiate a Phase 1 study in the months to come and to treat the first patient in the first half of 2024.
“Clearance of the IND for CT-0525 is a significant milestone in Carisma’s mission to develop innovative myeloid cell therapies for metastatic solid tumors,” said Steven Kelly, MBA, President and CEO of Carisma, as per PR Newswire. “Through this Phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility and mechanism of action of CT-0525.” Read more here.