NEW YORK – Verismo Therapeutics said Tuesday that it will begin studying its autologous cell therapy, SynKIR-310, in patients with advanced non-Hodgkin lymphoma.
The US Food and Drug Administration approved an investigational new drug application from Verismo, allowing it to begin evaluating the cell therapy's safety, tolerability, and preliminary efficacy in a Phase I trial involving patients with relapsed or refractory B-cell non-Hodgkin lymphoma. In the trial, Verismo will enroll patients into the trial, dubbed CELESTIAL-301, with diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma, regardless of whether they've received prior treatment with an autologous CAR T-cell therapy. Verismo plans to begin the study during the second half of 2024.
The investigational cell therapy that Verismo is studying, SynKIR-310, combines a novel CD19 binder and Verismo's SynKIR platform. The treatment is designed to target a CD19 epitope similar to the ones that commercially approved CD19 CAR T-cell therapies target but with enhanced persistence and T-cell function. Verismo believes that the proprietary binder it has designed to accomplish this, called DS191, can address some of the challenges that have hindered NHL patients from experiencing long-term benefits with commercially available CAR T-cell therapy.
"The SynKIR-310 technology … could potentially improve persistence and prevent early disease relapse in patients with aggressive lymphomas," Verismo CSO Laura Johnson said in a statement. "SynKIR-310 could be especially beneficial for patients that relapsed after previous infusions of CAR T-cell therapies."
The University of Pennsylvania spinout is also evaluating its autologous cell therapy approach in a Phase I trial, dubbed STAR-101, enrolling patients with solid tumors, including ovarian cancer, cholangiocarcinoma, and mesothelioma.