On May 26, 2022 Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that two presentations including findings of its lead candidate, CT-0508, accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, June 3-7 (Press release, Carisma Therapeutics, MAY 26, 2022, View Source [SID1234615141]). The company will present the latest data from its landmark CT-0508 chimeric antigen receptor macrophage (CAR-M) trial for patients with advanced metastatic HER2 overexpressing solid tumors, reaffirming safety and feasibility of its proprietary engineered cell therapy platform. Clinical trial design for phase 1 study of adenovirally transduced autologous macrophages, a second CT-0508 study, was also accepted for presentation.
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In the abstract "A Phase 1, first-in-human (FIH) study of the anti-HER2 CAR Macrophage CT-0508 in subjects with HER2 overexpressing solid tumors," Kim A. Reiss, MD, principal investigator of the Phase 1 clinical trial and an Assistant Professor of Hematology-Oncology at the Perelman School of Medicine at the University of Pennsylvania (Penn), will present an update on the ongoing clinical trial. The findings are the first clinical data of genetically engineered macrophages in humans and demonstrate that CT-0508 was well tolerated after infusion and there were no dose-limiting toxicities reported to date in the current study. CT-0508 was also successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and showed high chimeric antigen receptor (CAR) expression, viability, and purity. The data provide the first clinical demonstration of the CAR-M mechanism of action, exhibiting tumor infiltration, remodeling of the solid tumor microenvironment, and early indications of T-cell activation.
"This additional patient data reinforces the potential of the CAR-M platform, which may have applicability across other therapeutic areas in addition to HER2 over expressing cancers," said Debora Barton, MD, Chief Medical Officer at Carisma Therapeutics. "We look forward to continuing the CT-0508 clinical trial to further observe how our CAR-M therapy can potentially address the unmet needs of patients with hard-to-treat cancers."
Also accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting is, "A phase 1, first-in-human (FIH) study of adenovirally transduced autologous macrophages engineered to contain an anti-HER2 chimeric antigen receptor (CAR) in subjects with HER2 overexpressing solid tumors," overview of the design of the Phase 1 clinical trial, also presented by Dr. Reiss.
Both of the abstracts will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in the "Developmental Therapeutics—Immunotherapy" poster session on June 5.
Editor’s Note: Carisma 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 in the future. In addition, Penn is a co-founder of the company and holds equity interests in Carisma.
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. We are 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 our 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 Penn; 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.