Provention Bio, Inc., a clinical-stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced that it has entered into agreements with MacroGenics, Inc. involving two clinical-stage assets.
MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer.
Provention has acquired all rights to teplizumab to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.
PRV-031, a humanized, anti-CD3 monoclonal antibody, is expected to commence pivotal Phase 3 clinical trials in late 2019. The study will explore using PRV-031’s two-cycle treatment on approximately 350 pediatric and adolescent patients with an early-onset type 1 diabetes (T1D) diagnosis to demonstrate preservation of beta cell function, improvement in glycemic control and decreased insulin use.
Provention plans to continue PRV-3279 development in a multiple ascending dose Phase 1b/2a study as a potential treatment for systemic lupus erythematosus (SLE). PRV-3279 has been studied in humans and shown to be well tolerated. Proof of mechanism (PoM) and its inhibitory effect on induced immune response were demonstrated in a Phase 1a single ascending dose study. Provention plans to continue clinical development to determine if PRV-3279 can intercept the pathophysiology of SLE by preventing the production of autoantibodies by abnormally active B cells.