Verismo Therapeutics Announces FDA Approval of IND Application for SynKIR-110™, a KIR-CAR T Cellular Immunotherapy Candidate

Company to Initiate Phase 1 of First Ever KIR-CAR T Cell Clinical Trial in Q1 2023

PHILADELPHIA, PA, USA I September 20, 2022 I Therapeutic Verismoa clinical-stage biotechnology company and Penn spin-out behind novel KIR-CAR platform technology, today announced that it has received clearance for its Investigational New Drug (IND) application of the United States Food and Drug Administration (FDA) to initiate a first-in-man Phase 1 clinical trial of SynKIR-110.

The Phase 1 trial, STAR-101 (SynKIR J cell Aadvanced Research), will evaluate the safety, tolerability and preliminary efficacy of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma. This first-in-man trial aims to address several areas of unmet medical need. For each indication, the five-year survival rates are 49.7% for ovarian cancer, 30% for cholangiocarcinoma and 10% for mesothelioma. Patients suffering from these diseases urgently need an effective treatment option.

STAR-101 will mark the first-in-human study for SynKIR T cells, a next-generation cell therapy approach targeting solid tumors powered by the KIR-CAR platform. Its unique multi-chain KIR-CAR construction reduces T cell exhaustion through the natural on-off switch that allows cells to rest when not bound to the tumor, as well as stability of enhanced surface to improve cell performance in the harsh microenvironment of solid tumors.

“Preclinical data showed increased efficacy in mouse models without additional safety concerns. FDA clearance for our SynKIR-110 IND represents a new chapter for Verismo as we initiate the first-ever clinical trial for T-cells KIR-CAR also validates the years of innovative research and hard work of industry pioneers at Penn and the Verismo team,” said Dr. Bryan Kim, CEO of Verismo.

“SynKIR-110 is the first product to use the novel KIR-CAR platform. Our technology incorporates a natural on/off switch that allows KIR-CAR T cells to rest when not exposed to tumor antigens, while providing cell-surface stability of KIR-CAR,” said Dr. Laura Johnson, CSO of Verismo. “These improvements will allow KIR-CAR T cells to better cope with the challenging tumor microenvironment of solid tumors and, potentially , to improve outcomes for our patients.

Verismo expects to begin enrolling patients in the first quarter of 2023 at the initial clinical site, University of Pennsylvania Hospital.

ABOUT VERISMO THERAPEUTICS

Verismo Therapeutics is a pioneer of dual-chain KIR-CAR T cell technology, on track to bring its first active into first-in-human clinical trials in 2023. Verismo is the only company developing the KIR-CAR platform , a modified NK-type 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 with significant unmet medical needs. For more information visit: www.verismotherapeutics.com

ABOUT THE KIR-CAR PLATFORM

The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical models to be able to maintain T cell antitumor activity even in challenging solid tumor environments. Based on natural killer cell receptors, KIR-CAR provides natural T cell stimulation, without triggering T cell exhaustion. DAP12 co-stimulatory chains facilitate additional T cell stimulation pathways, further enhancing persistence cellular. This continued function and persistence can lead to continued regression of solid tumors in preclinical models, including those refractory to traditional CAR T-cell therapies. Additionally, 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 cell therapies to deliver therapy adaptable targeting tumors to patients who need it.

SOURCE: Verismo Therapeutics

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