Carisma Therapeutics Announces Clinical & Pre-Clinical Updates

New data from Phase 1 clinical trial of CT-0508 presented at SITC

Early pre-clinical data on CT-1119 and preliminary insights from novel immunotherapy platform also presented

PHILADELPHIA, PA, USA I November 11, 2022 I Carisma Therapeutics Inc. (Carisma Therapeutics), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, presented today at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting additional findings from its CT-0508 chimeric antigen receptor macrophage (CAR-M) clinical trial for patients with advanced metastatic human epidermal growth factor receptor 2 (HER2) overexpressing solid tumors, supporting a favorable safety profile and manufacturing feasibility of its proprietary engineered cell therapy platform.

The findings in the abstract, "A phase 1, first-in-human (FIH) clinical trial of the anti-HER2 CAR macrophage CT-0508 in participants with HER2 overexpressing solid tumors," demonstrate that CT-0508 has been successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and has shown high chimeric antigen receptor (CAR) expression, viability, and purity. In this clinical trial, CT-0508 has been generally well-tolerated after infusion with no dose-limiting toxicities reported to date from the nine participants enrolled in Group 1. The clinical trial data provide early clinical validation of the CAR-M mechanism of action, demonstrating that CT-0508 can be detected within the tumor microenvironment (TME), lead to remodeling and activation of the TME, and induce anti-tumor adaptive immunity. The data is drawn from the ongoing clinical trial led by Kim A. Reiss, MD, principal investigator of the Phase 1 clinical trial and an Assistant Professor of Hematology-Oncology at the Abramson Cancer Center at the University of Pennsylvania (Penn).

"The data from Group 1 of our first-in-human CAR-M clinical trial provides evidence that CAR-M therapy is feasible and generally well-tolerated by patients with certain late-stage metastatic cancers," said Michael Klichinsky, Pharm.D., Ph.D., Co-Founder and Chief Scientific Officer at Carisma Therapeutics. "The translational data collected from these patients is highly encouraging. We look forward to advancing CT-0508 into Group 2 of the monotherapy safety trial, as well as in a combination sub-study with the T cell checkpoint inhibitor pembrolizumab."

Additionally, in the abstract, "Pre-clinical development of CT-1119, a mesothelin targeting chimeric antigen receptor macrophage (CAR-M), for solid tumor immunotherapy," the presented data demonstrate that CT-1119, an autologous human anti-mesothelin CAR-M, can mediate phagocytosis, tumor cell killing, and pro-inflammatory cytokine release and control tumor growth in pre-clinical lung cancer models. This data demonstrates that CAR-M may be a feasible and differentiated approach that could be tested in the treatment of mesothelin expressing solid tumors such as lung cancer, mesothelioma, ovarian cancer, pancreatic cancer, and other solid tumors.

Also presented for the first time is a novel immunotherapy platform that harnesses macrophages as "living converters" to locally regulate the inflammatory state of tissues. The platform has potential for both oncology and inflammatory disease applications. In the abstract, "Macrophages engineered to express synthetic cytokine switch receptors act as living microenvironment converters," Carisma Therapeutics demonstrated a novel approach wherein macrophages expressing novel synthetic cytokine receptors are utilized to convert inflammatory signals into immunosuppressive responses or vice versa, offering modularity in controlling the inflammatory status of tissue microenvironments without systemic cytokine antagonism.

Details of Carisma Therapeutics' data also accepted for presentation at the SITC 37th Annual Meeting:

Presentation and posters will be available on the SITC 37th Annual Meeting portal for registered attendees.

About CT-0508
CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma Therapeutics is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for its CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at five U.S. sites, including Abramson Cancer Center at The University of Pennsylvania; the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill; City of Hope in Duarte, California; University of Texas MD Anderson Cancer Center in Houston, Texas; and Sarah Cannon Research Institute at Tennessee Oncology – Nashville.

About Carisma Therapeutics
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

*Carisma Therapeutics has licensed certain Penn-owned intellectual property from the University of Pennsylvania, and Penn's Perelman School of Medicine receives sponsored research and clinical trial funding from the company. Penn may also be entitled to receive additional financial benefits from technologies licensed and optioned to Carisma Therapeutics in

SOURCE: Carisma Therapeutics

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