Verismo Therapeutics Inc. has submitted an IND application to the FDA seeking to initiate a phase I trial this year of Synkir-310 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.
Y-Mabs Therapeutics Inc. has received FDA clearance of its IND application for CD38-SADA, the company’s second program within its SAYA Y-PRIT (Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy) theranostic platform.
Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year.
Immuno-oncology company Imugene Ltd. has acquired a worldwide exclusive license to Precision Biosciences Inc.’s allogeneic CD19 CAR T-cell therapy program in a deal worth more than $227 million. The off-the-shelf CD19 CAR T-cell therapy, azercabtagene zapreleucel (azer-cel), could potentially be the first allogeneic CAR T to be approved, Imugene CEO Leslie Chong told BioWorld.
Boston Immune Technologies and Therapeutics Inc. (BITT) has received IND clearance from the FDA for a first-in-human trial of BITT-2101, a monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2), in patients with relapsed or refractory non-Hodgkin lymphomas (NHLs).
Immuno-oncology company Imugene Ltd. has acquired a worldwide exclusive license to Precision Biosciences Inc.’s allogeneic CD19 CAR T-cell therapy program in a deal worth more than $227 million. The off-the-shelf CD19 CAR T-cell therapy, azercabtagene zapreleucel (azer-cel), could potentially be the first allogeneic CAR T to be approved, Imugene CEO Leslie Chong told BioWorld.
Salarius Pharmaceuticals Inc. has received FDA clearance of its IND application to initiate a phase I trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).
Hanchorbio Inc. has received IND clearance by the FDA to initiate a clinical trial of HCB-101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma (NHL).