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July 27, 2020
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FDA clears IND for first CAR macrophage cell therapy for HER2-positive tumors

Source:

Press Release

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The FDA cleared an investigational new drug application for CT-0508 for the treatment of solid tumors that overexpress HER2, according to the agent’s manufacturer.

CT-0508 (Carisma Therapeutics) is an autologous chimeric antigen receptor macrophage therapy that targets the HER2 protein on the surface of solid tumor cells.

Sign outside FDA HQ in Washington, DC.

The company’s technology capitalizes on previous cell therapies by using genetically engineered macrophages — instead of T cells — that are naturally drawn into solid tissues and help modulate the tumor microenvironment.

Carisma’s CAR macrophage technology was developed as part of a collaboration with University of Pennsylvania.

“The clearance of our IND application for CT-0508 is a groundbreaking milestone in the field of cell-based cancer immunotherapy,” Steven Kelley, president and CEO of Carisma Therapeutics, said in a company-issued press release. “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."

The FDA clearance allows Carisma to start a phase 1, first-in-human, multicenter clinical trial of CT-0508 for patients with recurrent or metastatic HER2 overexpressing solid tumors who previously received HER2-targeted agents. The planned trial sites include University of Pennsylvania The University of North Carolina at Chapel Hill.

“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,” Debora Barton, MD, chief medical officer at Carisma Therapeutics, said in the release. “There is an important unmet medical need that remains to be addressed and we aim to achieve that during this clinical trial.”