Carisma Therapeutics announced the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the Company's lead product candidate, CT-0508, an anti-human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). Under this IND, Carisma intends to initiate its Phase 1, first-in-human, multi-center study in patients with recurrent or metastatic HER2 overexpressing solid tumors after failure of approved HER2 targeted agents.

"This will be the first time that an engineered macrophage has progressed successfully to the in-patient study phase and represents a new chapter for CARISMA: advancing from a preclinical discovery-stage company to a clinical development stage company," said Steven Kelly, President and Chief Executive Officer. "The clearance of our IND application for CT-0508 is a ground-breaking milestone in the field of cell-based cancer immunotherapy."

Historically, cell therapies have encountered key challenges treating solid tumors, including limited trafficking to the tumor site, an immunosuppressive tumor microenvironment, and the heterogeneous expression of tumor-associated antigens, but Carisma's preclinical findings suggest that CAR-M therapy could overcome these challenges.

"Our preclinical findings indicate that CAR-M have the ability to mount a broad immune response against cancers, and the acceptance of the CT-0508 IND brings this technology to patients with incurable solid tumors," said Michael Klichinsky, PharmD, PhD, co-inventor of the CAR-M technology, Scientific Co-founder, and Vice President of Discovery at Carisma Therapeutics. 

The planned clinical trial will be conducted at two trial sites—University of Pennsylvania in Philadelphia, Pennsylvania, and University of North Carolina in Chapel Hill, North Carolina—and will enroll patients with different types of recurrent or metastatic cancers with HER2 overexpressing solid tumors.

"HER2 is overexpressed not only in breast and gastroesophageal cancers, but in a wide variety of epithelial origin solid tumors, such as non-small cell lung, colorectal, bladder, and pancreatic cancers," said Debora Barton, MD, Chief Medical Officer at Carisma Therapeutics. "There is an important unmet medical need that remains to be addressed and we aim to achieve that during this clinical trial."