CARISMA Therapeutics Announces First Patient Dosed in Landmark Clinical Study Evaluating Engineered Macrophages in Humans

Clinical trial to study CT-0508 in patients with metastatic HER2 overexpressing solid tumors

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Mar 18, 2021, 08:00 ET

PHILADELPHIA, March 18, 2021 /PRNewswire/ -- CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company spun out of the University of Pennsylvania (Penn) and focused on discovering and developing innovative immunotherapies, announced that the first patient has been dosed in the Phase 1 multi-center clinical trial for CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M).

This clinical trial represents a pivotal milestone in gene-based therapy development, as it is the first time CAR-engineered macrophages are being used in a clinical study. The study 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.

"Through our novel CAR-M platform, CARISMA plans to develop new treatment options that aim to address the unmet needs of patients who are battling hard-to-treat cancers," said Debora Barton, MD, Chief Medical Officer at CARISMA Therapeutics. "After much investigation in the lab, we are looking forward to evaluating CT-0508 in a clinical setting to assess this first CAR-engineered macrophage product and also provide vital learnings for a potential new way of treating cancer."

CT-0508 was originally developed by Saar Gill, MD, PhD, Scientific Co-founder of CARISMA Therapeutics, and an Assistant Professor of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania and the Center for Cellular Immunotherapies at Penn's Abramson Cancer Center, and Michael Klichinsky, PharmD, PhD, Scientific Co-founder, and Senior Vice President of Discovery at CARISMA Therapeutics.

"The preclinical findings suggest that CAR-Ms access solid tumors, survive in a hostile tumor environment, specifically phagocytose antigen-expressing cancer cells, and trigger an adaptive, long-lasting immune response," Gill said. "This is the first time this kind of technology is being explored in humans, and we are excited to collect important data from this trial that will help to validate the platform as a potential new therapeutic approach for these patients."

The clinical trial is open for enrollment and details can be found at ClinicalTrials.gov. CARISMA will continue to treat and evaluate patients at two clinical trial sites, including the University of Pennsylvania and the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill.

About CARISMA Therapeutics Inc.
CARISMA Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. CARISMA Therapeutics is headquartered in Philadelphia, PA.

For more information, please visit www.carismatx.com

Editor's Note: Saar Gill, MD, PhD, an assistant professor of Hematology-Oncology in Penn's Perelman School of Medicine. The Abramson Cancer Center and Penn are both co-founders of CARISMA and hold equity in the company. CARISMA has licensed certain Penn-owned intellectual property from the University, and Penn's Perelman School of Medicine receives sponsored research funding from the company in support of Dr. Gill's laboratory and clinical trials at Penn. Penn and Dr. Gill may also be entitled to receive future financial benefits from technologies licensed and optioned to CARISMA.

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SOURCE CARISMA Therapeutics Inc.