Verismo Submits FDA Application for IND Approval of SynKIR™-310 for Treating Recurrent or Refractory B-cell NHL

Verismo Therapeutics, a company specializing in CAR T-cell therapies, is progressing with its second clinical trial using the SynKIR™ platform. The trial focuses on patients suffering from various subtypes of B-cell Non-Hodgkin Lymphoma (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL), who have either relapsed after CAR T-cell therapy or are unresponsive to it. The IND application for SynKIR™-310 has been submitted to the FDA for this Phase 1 clinical study.
Despite the high initial response rates of approved CAR T-cell therapies, relapses occur in about 40-50% of patients, largely due to the therapies' inability to maintain long-term T cell function and presence. Verismo aims to address this issue with SynKIR™-310, which utilizes a proprietary CD19 binder, DS191, developed to target B-cell disorders and potentially extend the lifespan of anti-tumor T cells.
Dr. Laura Johnson, Verismo's Chief Scientific Officer, expressed optimism about SynKIR™-310's potential to enhance T cell persistence and prevent early relapse in aggressive lymphomas. The clinical trial, named CELESTIAL-301, is set to commence in 2024, following regulatory approval.
The KIR-CAR platform, which SynKIR™-310 is based on, is a multi-chain CAR T-cell therapy that has demonstrated the ability to sustain anti-tumor activity in challenging conditions. This novel approach combines NK cell-derived KIR and DAP12 signaling, offering a distinct activation and co-stimulation mechanism. The platform is being explored in conjunction with other emerging technologies to develop advanced, targeted immunotherapies for patients.
Verismo's flagship product, SynKIR™-110, is already in Phase 1 clinical trials (STAR-101) and is expected to expand to additional sites in the second quarter of 2024. The company is a frontrunner in KIR-CAR technology, focusing on improving treatment outcomes for aggressive tumors and B-cell related conditions, which are areas with significant unmet medical needs.

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