#United States #Denver #Verismo Therapeutics #SynKIR-310 #CELESTIAL-301

Verismo Therapeutics Begins CELESTIAL-301 Trial for SynKIR™-310

Verismo Therapeutics, a cutting-edge clinical-stage CAR T company, has officially commenced its Phase 1 clinical trial named CELESTIAL-301, focusing on SynKIR™-310. This innovative drug candidate is aimed at treating relapsed and refractory B cell Non-Hodgkin Lymphomas (NHL), including Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL).

The announcement was made on January 10, 2025, following the dosing of the first patient at the Sarah Cannon Research Institute (SCRI) located within the Colorado Blood Cancer Institute (CBCI) in Denver. The CELESTIAL-301 trial's primary objectives are to evaluate the safety, tolerability, and preliminary efficacy of the SynKIR™-310 treatment in patients previously treated with CAR T therapies who have either relapsed or become resistant to them, as well as new patients who have not undergone CAR T treatment yet.

Addressing Unmet Medical Needs

The clinical trial seeks to address a significant gap in the treatment landscape for patients suffering from advanced B cell NHL. Currently, commercially approved CAR T cell therapies exhibit high initial response rates; however, they can lead to relapse in approximately 40 to 50% of cases, primarily due to the limited long-term T cell functionality. This creates a pressing need for alternative treatment options for patients who have experienced relapse following conventional CAR T therapies.

SynKIR™-310 leverages Verismo's proprietary KIR-CAR platform and a unique CD19 binder (DS191), targeting the same CD19 antigen as existing CAR T therapies while aiming to enhance the persistence and functional longevity of T cells. These advancements are expected to potentially prevent early onset of disease relapse in patients with advanced B cell lymphomas.

Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics, expressed excitement about this milestone. She stated, "The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas. CBCI's commitment to patients and early-stage clinical trials has allowed us to reach this milestone sooner than anticipated."

Clinical Collaboration and Expectations

Alongside Dr. Johnson, Dr. Michael Tees, the principal investigator at SCRI, shared his enthusiasm about administering SynKIR™-310. He emphasized the potential of emerging treatments to transform care for patients with advanced lymphomas, bringing new hope to those who might have limited options.

Verismo gained Investigational New Drug (IND) clearance from the U.S. FDA in May 2024, enabling this multicenter Phase 1 clinical trial. SynKIR™-310 is the second in Verismo's clinical pipeline, following SynKIR™-110, which targets aggressive mesothelin-expressing solid tumors.

About Verismo Therapeutics

As a subsidiary of HLB Innovation, Verismo Therapeutics is at the forefront of developing multi-chain KIR-CAR technology. The firm's approach, using a modified receptor from NK cells paired with DAP12, aims to enhance the efficacy and durability of treatments targeting aggressive tumors. Their KIR-CAR platform is unique in addressing the unmet healthcare needs associated with advanced lymphomas and solid tumors.

To learn more about the CELESTIAL-301 clinical trial, researchers and patients can visit ClinicalTrials.gov and search for NCT06544265. Through these endeavors, Verismo Therapeutics is committed to offering innovative solutions that could change the treatment paradigm for patients grappling with challenging cancers.