Verismo Therapeutics Announces First Patient Infused in Phase 1 CELESTIAL-301 Clinical Trial of SynKIR™-310

Clinical-stage CAR T company dosed first patient for Phase 1 trial to evaluate SynKIR™-310, a new drug candidate for relapsed/refractory B cell Non-Hodgkin Lymphomas 

PHILADELPHIA, Jan. 10, 2025 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, today announced that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial. The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

CELESTIAL-301 aims to 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 Phase 1 multicenter clinical trial is enrolling 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 due in part 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.

SynKIR™-310 relies on Verismo's unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR™-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas.

"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 to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected," according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. "SynKIR™-310 is uniquely designed to prolong T cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients."

"We are thrilled to administer this promising therapy," said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. "Emerging treatments like SynKIR™-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials."

Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR™-310. SynKIR™-310 is Verismo's second clinical pipeline following SynKIR™-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265.

About Verismo Therapeutics

Verismo Therapeutics, a subsidiary of HLB Innovation, is a pioneer in multi-chain KIR-CAR technology, with its first assets SynKIR™-110 and SynKIR™-310 currently in Phase 1 clinical trials. 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 to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: www.verismotherapeutics.com

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 tumor regression in preclinical models that are resistant to traditional CAR T cell therapies.

Forward Looking Statements

This press release contains forward-looking statements, including, but are not limited to, those statements regarding our expectations for the timing, progress, and results of clinical trials; potential regulatory approvals; anticipated benefits, safety, and efficacy of our product candidates; our product development strategies; and other statements that are not historical facts. These forward-looking statements are based on our current expectations and are subject to numerous risks and uncertainties that could cause actual outcomes to differ materially. Important factors that could cause actual results to differ include, among others, risks related to clinical trials, regulatory processes, market acceptance, financial projections, and our ability to successfully develop and commercialize our product candidates. Forward-looking statements in this release represent our beliefs and assumptions only as of the date hereof, and we expressly disclaim any obligation to update these statements as new information becomes available, except as required by law.

¹Blood Adv (2020) 4 (22): 5607-5615 https://doi.org/10.1182/bloodadvances.2020003001; Biol Blood Marrow Transplant (2019) 25(11): e344-e351 https:doi.org/10.1016/j.bbmt.2019.06.036; Front Pediatr (2024) 11. https://doi.org/10.3389/fped.2023.1305657

Media Contact, Verismo Therapeutics
Pavel Aprelev
[email protected]

SOURCE Verismo Therapeutics