Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-110TM, a KIR-CAR T-cell Immunotherapy Candidate
19 Aug 2022
Cell TherapyImmunotherapy
Company advances towards in-human clinical trials for SynKIRTM platform targeting Mesothelin-Expressing Advanced Ovarian CancerMesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, and Mesothelioma
PHILADELPHIA, Aug. 19, 2022 /PRNewswire/ -- Verismo Therapeutics, a Penn-spinout and the company behind the novel KIR-CAR platform technology for CAR T-cell therapy, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to initiate its first-in-human Phase 1 clinical trial of SynKIR-110 in patients with mesothelin-expressing ovarian cancer, mesothelioma and cholangiocarcinoma.
Pending regulatory approval, the company plans to initiate the STAR-101 (SynKIR T cell Advanced Research) trial in Q1 2023. This trial will mark the first-in-human study of the KIR-CAR platform technology, which harnesses the power of natural killer (NK) cells in genetically re-engineered CAR T-cells and aims to shift the paradigm of treatment of solid tumors.
"Initiation of the STAR-101 clinical trial based on the KIR-CAR platform technology is a momentous company milestone that represents years of research from industry pioneers and the tremendous focus and commitments of the Verismo team," said Dr. Bryan Kim, CEO of Verismo. "We are thrilled to advance our treatment one step closer to helping patient populations with severely unmet medical needs."
ABOUT VERISMO THERAPEUTICS
Verismo Therapeutics is a pioneer in dual-chain KIR-CAR technology, on track to bring its first asset into first-in-human clinical trials in 2023. Verismo is the only company developing the KIR-CAR platform, a modified NK cell receptor designed to improve persistence and efficacy against aggressive solid tumors. The KIR-CAR platform technology was developed specifically for advanced solid tumors, an area of high unmet medical need. For more information, visit:
ABOUT KIR-CAR PLATFORM
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical models to be capable of maintaining antitumor T-cell activity even in challenging solid tumor environments. Based on natural killer cell receptors, KIR-CAR provides a natural on-and-off stimulation to the T-cell, without triggering T cell exhaustion. DAP12 costimulatory chains aid additional T-cell stimulating pathways, further improving cell persistence. This continued function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those refractory to traditional CAR T-cell therapies. Furthermore, the KIR-CAR platform can be combined with many additional emerging technologies, such as in-vivo gene editing, advanced T cell selection, combination therapies, and even allogeneic cellular therapies to provide an adaptable tumor-targeting therapy for patients in need.
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