July 27, 2020 -- Carisma Therapeutics' engineered macrophage immunotherapy has cleared an investigational new drug (IND) application through the U.S. Food and Drug Administration. The company intends to initiate a phase I clinical trial for the candidate this year.
The company's lead candidate, CT-0508, is a chimeric antigen receptor macrophage (CAR-M) that is targeted at anti-human epidermal growth factor receptor 2 (HER2). The phase I clinical trial will be evaluated in patients with recurrent or metastatic HER2 overexpressing solid tumors after failure of approved HER2-targeted agents. The clinical trials will be conducted at two trial sites at the University of Pennsylvania and the University of North Carolina at Chapel Hill.
Preclinical findings suggest that the company's CAR-M therapy could provide broad immune responses against solid tumors. The acceptance of the IND marks Carisma's transition from a discovery-based firm to a clinical development stage company.
The company also announced that it has expanded its board of directors and scientific advisory board.
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