Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

2024-04-03

临床1期细胞疗法免疫疗法临床申请

Company advances towards their second clinical trial for SynKIR™ platform treating patients with Diffuse Large B Cell Lymphoma and other B-cell Non-Hodgkin Lymphoma subtypes who are relapsed or refractory after standard of care, including CAR T therapies

PHILADELPHIA, April 3, 2024 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial of SynKIR™-310, for the treatment of relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL).

The company plans to treat patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy.

Commercially approved CAR T cell therapies have shown impressively high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are in part due to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies. Ongoing clinical investigations into new and/or salvage therapies for these patients have not yet addressed the unmet medical need.

SynKIR™-310 relies on Verismo's proprietary CD19 binder (DS191). The binder was developed specifically for the KIR-CAR platform technology to enable treatment of B-cell associated disorders and malignancies. SynKIR™-310 is directed by DS191 to target a similar epitope of CD19 as the commercially approved CAR T therapies, with the added potential to prolong the anti-tumor T cell function and persistence. Verismo's co-founders Dr. Donald Siegel and Dr. Michael Milone are co-inventors of the binder.

"Verismo is in a unique position with SynKIR™-310, to address the challenges associated with the current treatment of relapsed/refractory B-cell NHL, including relapse after treatment with commercially approved CAR T therapies," said Dr. Laura Johnson, Chief Scientific Officer of Verismo Therapeutics. "We believe SynKIR™-310, comprised of a split-chain KIR-CAR incorporating our novel DS191 binder, has the potential to prolong T cell anti-tumor function, and improve persistence in patients with aggressive lymphomas, preventing early disease relapse. Initiation of the clinical trial is the culmination of years of focused research and diligent work by the Verismo team."

Pending regulatory approval, the company plans to initiate the clinical trial (named CELESTIAL-301) in 2024. This trial will mark the company's second clinical study investigating the KIR-CAR platform technology, which harnesses the power of natural NK cell receptors and aims to shift the paradigm of T cell therapies. Verismo's leading pipeline, SynKIR™-110, is currently undergoing investigation in Phase 1 clinical trial (STAR-101) [NCT05568680] at two sites with plans to open two additional sites in Q2 2024.

About the KIR-CAR Platform

The KIR-CAR platform is a multi-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 tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors in preclinical models that are resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.

About Verismo Therapeutics

Verismo Therapeutics is a pioneer in multi-chain KIR-CAR technology, with its first asset SynKIR™-110 currently in a first-in-human Phase 1 clinical trial. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell derived receptor and DAP12 pairing, designed to improve persistence and efficacy against aggressive tumors. The KIR-CAR platform technology was developed specifically for treating advanced solid tumors and B cell associated disorders and malignancies, areas of high unmet medical need. For more information, visit: www.verismotherapeutics.com

1 Blood Adv (2020) 4 (22): 5607-5615; Biol Blood Marrow Transplant (2019) 25(11): e344-e351; Front Pediatr (2024) 11. https://doi-org.libproxy1.nus.edu.sg/10.3389/fped.2023.1305657

CONTACT: Raymond Luke; [email protected]

SOURCE Verismo Therapeutics