Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) for the treatment of patients with solid tumors.
“The FDA’s decision to grant Fast Track designation to CT-0508 is another important milestone in gene-based cell therapy development,” said Steven Kelly, Chief Executive Officer of CARISMA. “This designation further demonstrates the critical need to expedite the development and review of new therapies that can potentially address the unmet needs of patients, whose cancer may have not responded to existing methods of treatment.”
CT-0508 was originally developed by Saar Gill, MD, PhD, Scientific Co-founder of CARISMA Therapeutics, and an Associate Professor of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania, and Michael Klichinsky, PharmD, PhD, Scientific Co-founder, and Senior Vice President of Discovery at CARISMA Therapeutics. It is currently being evaluated in a first-in-human Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have any approved HER2-targeted therapies or who do not respond to treatment. Preclinical findings for CT-0508 indicated that CAR-M therapy may have the potential to overcome challenges that T-cell therapies have encountered in the solid tumor setting.
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