Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).
Syntax Bio Inc. has established a research and development collaboration with Mayo Clinic focused on advancing stem cell-derived pancreatic cell therapies for type 1 diabetes.
At the recent American Diabetes Association meeting, researchers from Century Therapeutics Inc. presented preclinical efficacy data on CNTY-813, an induced pluripotent stem cell (iPSC)-derived cell therapy engineered using the company’s proprietary Allo-Evasion 5.0 platform.
Newcelx Ltd. has submitted a pre-IND briefing package to the U.S. FDA to support a proposed first-in-human trial of NCEL-101 in combination with tegoprubart, an investigational anti-CD40L monoclonal antibody being developed by Eledon Pharmaceuticals Inc.
Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
Researchers from Sab Biotherapeutics Inc. presented data generated in the development and validation of a pharmacokinetic (PK) assay for SAB-142 and the evaluation of its toxicology and immunologic effects in a juvenile cynomolgus monkey model.
Newcelx Ltd. has entered into a collaborative research agreement with Eledon Pharmaceuticals Inc. with the aim of advancing its lead program, NCEL-101, for type 1 diabetes.
Ahead Therapeutics SL has been awarded an Industry Discovery and Development Partnership (IDDP) grant from Breakthrough T1D to support progression of the company’s proprietary Mimi-Top (mimicking tolerogenic particles) platform.
Century Therapeutics Inc. has announced its first program for type 1 diabetes, CNTY-813. The program comprises induced pluripotent stem cell (iPSC)-derived β islets engineered with the company’s proprietary Allo-Evasion 5.0 technology, designed to protect from T-cell, NK-cell and humoral immune rejection, with the goal of durable glycemic control without the need for systemic immunosuppression.
