Verismo Therapeutics, a clinical-stage CAR T company developing the novel KIR-CAR platform technology, today announced that it has received a notification from the US Food and Drug Administration (FDA) that the Phase 1 clinical trial of SynKIR™-310 for the investigation of NHL may proceed.

The Phase 1 trial, named CELESTIAL-301, will assess safety, tolerability, and preliminary efficacy of SynKIR™-310 in patients with 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 study will enroll 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.

CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive 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 unique KIR-CAR platform and 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 Therapeutics is uniquely positioned with SynKIR™-310 to address the significant challenges in treating relapsed/refractory B-cell NHL. This includes cases where patients have relapsed after receiving approved CAR T therapies," stated Dr. Laura Johnson, Chief Scientific Officer of Verismo Therapeutics. "The SynKIR™-310 technology is designed to enhance the anti-tumor activity and extend the efficacy of T cells. This could potentially improve persistence and prevent early disease relapse in patients with aggressive lymphomas. SynKIR™-310 could be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies."

Verismo plans to initiate the CELESTIAL-301 clinical trial in the second half of 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 being investigated in Phase 1 clinical trial (STAR-101) [NCT05568680] at two sites with plans to open additional sites in 2024.