PHILADELPHIA, PA — Carisma Therapeutics Inc. (Nasdaq: CARM) recently announced that its Investigational New Drug application (IND) for CT-0525 has been cleared by the U.S. Food and Drug Administration (FDA). CT-0525 is an innovative gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy designed to treat solid tumors overexpressing human epidermal growth factor receptor 2 (HER2).
Following this clearance, Carisma expects to commence a Phase 1 study in the coming months, with the first patient anticipated to be treated in the first half of 2024.
Steven Kelly, President and Chief Executive Officer of Carisma, said, “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.”
As the precursor cells to macrophages, monocytes offer several potential benefits in treating solid tumors. The CAR-Monocyte manufacturing platform can produce up to 10 billion cells from a single apheresis in a rapid, single-day process. This technique could considerably reduce future costs and manufacturing turnaround time associated with this autologous cell therapy.
Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma, added, “CT-0525 is the first CAR-Monocyte to be evaluated in the solid tumor setting. With a CAR-Monocyte’s in vivo persistence, ability to differentiate into pro-inflammatory CAR macrophages, and multi-modal anti-tumor mechanism of action, along with its high cell yield, CT-0525 has the potential to improve the treatment paradigm for patients with HER2 overexpressing metastatic solid tumors.”
The forthcoming Phase 1 study aims to assess the safety, tolerability, and manufacturing feasibility of CT-0525. The study will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2, whose disease has progressed on standard approved therapies.
This development signifies a significant step forward in the treatment of solid tumors, potentially transforming the landscape of cancer therapy and offering new hope to patients across the globe.
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