On September 6, 2023 Verismo Therapeutics, a clinical-stage CAR-T company developing novel KIR-CAR platform technology invented at and licensed from the University of Pennsylvania ("Penn"), reported that a first patient has been dosed in their STAR-101 clinical trial to study the SynKIR-110 product in individuals with advanced ovarian cancer, mesothelioma, and cholangiocarcinoma (Press release, Verismo Therapeutics, SEP 6, 2023, View Source [SID1234634962]). The Phase 1 clinical trial, designed to evaluate the safety, feasibility, and potential activity of SynKIR-110, represents a crucial step forward in improving treatment options in patients with mesothelin-expressing solid tumors.
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STAR-101 (NCT05568680) is a first-in-human trial that aims to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of the SynKIR-110 product, which is comprised of autologous T cells transduced with a mesothelin-targeted KIR-CAR. By targeting mesothelin-expressing ovarian cancer, mesothelioma, and cholangiocarcinoma, SynKIR-110 holds potential for creating a new treatment option for these challenging malignancies.
"This represents a significant milestone for our company and demonstrates the commitment of our team to address the critical need for additional treatment options for patients with mesothelin-expressing solid tumors," said Dr. Bryan Kim, Co-Founder and CEO of Verismo Therapeutics. "We’re proud to work with the distinguished team at Penn to take our SynKIR-110 treatment out of the lab and to the patients with unmet medical needs."
The STAR-101 clinical trial will encompass an intervention period, during which subjects will receive non-myeloablative lymphodepleting chemotherapy followed by a single infusion of SynKIR-110, as well as a 12-month follow-up period. For more information on the STAR-101 clinical trial, please visit ClinicalTrials.gov – NCT05568680.
"We are excited to initiate this Phase 1 clinical trial of SynKIR-110, which, based on preclinical testing in relevant animal models, holds promise as a potential new therapeutic for patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma," said Dr. Janos L. Tanyi, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and a principal investigator for the trial, "By leveraging the power of autologous T cells transduced with Mesothelin KIR-CAR, we hope to enhance treatment options and ultimately improve outcomes for patients facing these challenging malignancies."
About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.