Provention Bio, Inc., a clinical-stage biopharma company developing therapeutics for immune-mediated diseases, has entered into agreements with MacroGenics, Inc. to acquire all rights to teplizumab (to be further developed as PRV-031) and licensing rights to MGD010 for development as PRV-3279.
 
MacroGenics will receive a warrant to purchase a minority equity interest in Provention and will be eligible to receive future milestone payments and royalties on future net sales.
 
PRV-031, a humanized, anti-CD3 monoclonal antibody, is expected to enter Phase III trials in late 2019, in 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.
 
PRV-3279 is a humanized bi-specific molecule designed to simultaneously target the B-cell surface proteins CD32B and CD79B. 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).
 
“Our agreements with MacroGenics expand Provention’s pipeline with two additional clinical-stage assets that align perfectly with our mission to intercept or prevent immune-mediated diseases,” said Ashleigh Palmer, co-founder and chief executive officer of Provention Bio, Inc. “In less than a year since announcing our founding financing, Provention has secured five clinical stage assets in the burgeoning field of disease prevention and interception.”
 
“Given MacroGenics’ current focus on its immuno-oncology pipeline, we believe Provention Bio will be an excellent partner to progress these programs and potentially bring these innovative medicines to patients suffering from serious autoimmune disorders,” said Scott Koenig, M.D., Ph.D., president and chief executive officer of MacroGenics.