Provention Bio has had a rough 2021 with its lead drug, for Type 1 diabetes, getting the FDA red light, but November has shown signs of hope. The biotech made its third leadership hire this month by snagging Jan Hillson, M.D., as senior vice president of clinical development.
The new leader joins from Alpine Immune Sciences, where she held the same post. Hillson's background also includes an SVP of clinical and translational research post at ChemoCentryx and stints at Momenta Pharmaceuticals, ZymoGenetics, Bristol Myers Squibb and Xcyte Therapies.
Hillson joins as Provention looks to beef up its leadership team while it awaits a Type A meeting with the FDA to discuss lead drug teplizumab, which was rejected by the regulator in July. The agency asked for more data on the Type 1 diabetes drug. The biotech expects to meet with the FDA later this month, Provention said in its third quarter earnings on Nov. 4. After that meeting, Provention will work with the FDA to see what the drug's commercial path looks like.
In the meantime, the company hired a new chief financial officer, Thierry Chauche from Alexion Pharmaceuticals, and an SVP of research and early development, Miguel Sanjuan, Ph.D., who was formerly a Gossamer Bio leader.
RELATED: Provention Bio, hit by rejection for lead drug, hires early research exec from Gossamer
Now, Hillson comes on board to help shore up the clinical development of assets like a mid-stage lupus drug. Her resume includes developing drugs for autoimmune disorders, including systemic lupus erythematosus. That history will be critical as the biotech plans to start a phase 2a trial of its PRV-3279 asset in the disease, in which tissues are attacked by the immune system, later this quarter.
Hillson has also helped lead phase 3 development of another drug that wavered through a rocky regulatory path. While SVP of drug development at ChemoCentryx, from 2016 to early 2019, she played a key role in the phase 3 work of avacopan for the treatment of vasculitis. The oral treatment, named Tavneos, scored the FDA green light last month after multiple concerns were raised over its filing five months prior. It's the first approval in the company's 24-year history.