HLB Group's US Subsidiary Verismo Initiates Phase 1 Clinical Trial for Blood Cancer CAR-T Therapy

Verismo Therapeutics, a next-generation CAR-T therapy development company under HLB Group, has initiated a Phase 1 clinical trial (CELESTIAL-301) at the Sarah Cannon Research Institute of the Colorado Blood Cancer Institute (CBCI).

This clinical trial aims to develop the next-generation CAR-T therapy, SynKIR-310, as a treatment for relapsed/refractory B-cell non-Hodgkin lymphoma (B-cell NHL).

CBCI, conducting the clinical trial, is the leading institution operating hematology and bone marrow transplant programs in Colorado, USA. The CELESTIAL-301 trial is being conducted through the Sarah Cannon Research Institute (SCRI) within CBCI, one of the world's most prominent clinical research organizations.

The CELESTIAL-301 clinical trial will evaluate the safety, tolerability, and preliminary efficacy of SynKIR-310. It targets patients who have relapsed or are refractory after CAR-T therapy as well as those who have not previously received CAR-T treatment. In addition to B-cell non-Hodgkin lymphoma, patients with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) are included. This field still has a high unmet medical need, and Verismo is pursuing new drug development through this trial to address gaps left by existing therapies.

Approved CAR-T therapies show high initial response rates in hematologic cancers, but it is estimated that about 40-50% of patients relapse over time. This phenomenon is believed to be due to the reduced long-term persistence of T-cell effects.

SynKIR-310 was developed based on Verismo’s proprietary KIR-CAR platform and exclusive CD19 binder (DS191). It targets an epitope of CD19 similar to that of currently commercialized CAR-T cell therapies. Notably, Verismo’s SynKIR-310 is gaining attention for its potential to deliver strong antitumor T-cell function while addressing the persistence issues that have been limitations of existing CAR-T therapies.

Dr. Laura Johnson, Chief Scientific Officer (CSO) of Verismo, stated, "This clinical trial reflects Verismo’s technology and efforts to develop fundamental treatments for hard-to-treat cancers with high unmet medical needs. SynKIR-310 will offer new hope to patients with B-cell non-Hodgkin lymphoma, especially those who have relapsed after prior CAR-T therapy."

Verismo received FDA approval for the Investigational New Drug (IND) application for SynKIR-310 in May of this year. Separately, clinical trials for mesothelin-expressing solid tumors are also underway.

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