Provention Bio has entered into agreements with MacroGenics involving two clinical-stage assets. Provention has acquired all rights to teplizumab to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.
"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 CEO of Provention Bio. "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."
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"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.
Under the terms of the agreements, 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 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.
PRV-3279, a humanized bi-specific molecule that was 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) at Provention.
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.