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

Company to initiate Phase 1 of the first-ever clinical trial for KIR-CAR T cells in Q1 2023

PHILADELPHIA, PA, USA I September 20, 2022 I Verismo Therapeutics, a clinical-stage biotechnology company and a Penn-spinout behind the novel KIR-CAR platform technology, today announced that is has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1 clinical trial of SynKIR-110.

The Phase 1 trial, STAR-101 (SynKIR T cell Advanced Research), will assess safety, tolerability, and preliminary efficacy of SynKIR-110 in patients with mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma. This first-in-human trial seeks to address several areas of high 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 a successful treatment option.

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

"Pre-clinical data have shown enhanced efficacy in murine models with no additional safety concerns. The FDA's clearance of our SynKIR-110 IND represents a new chapter for Verismo as we initiate the first-ever clinical trial for KIR-CAR T cells. It also validates the years of innovative research and hard work by 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, as well as providing an enhanced cell-surface stability of the KIR-CAR," said Dr. Laura Johnson, CSO of Verismo. "These enhancements will allow KIR-CAR T cells to better cope with the harsh tumor microenvironment of solid tumors and, potentially, lead to better outcomes for our patients."

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

ABOUT VERISMO THERAPEUTICS

Verismo Therapeutics is a pioneer in dual-chain KIR-CAR T cell 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-like 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: www.verismotherapeutics.com

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.

SOURCE: Verismo Therapeutics

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