Life Sciences Insight

Provention Bio, hit by AdComm rejection for lead drug, hires early research exec from Gossamer

Provention Bio has come out with a little bit of good news amid a tough 2021 as it hires former Gossamer Bio early R&D lead Miguel Sanjuan, Ph.D., to help shore up its early shots on goal.

At the immune disease biotech, Sanjuan will become senior vice president of research and early development with a focus on its phase 1 and preclinical work, which is made up of assets for lupus, prevention of diabetes and celiac disease, a program partnered with Amgen.

These programs may become more pivotal for the biotech in the future, given the troubles its leading drug teplizumab for Type 1 diabetes has endured this year.

In July, the biotech’s shares took a battering on an FDA complete response letter for the drug, and the agency asked for more data related to the drug product that was used in historical trials and the planned commercial product.

It also demanded a “safety update” as part of the resubmission; The biotech is now working on these issues and will provide an update later this year, but, after a bruising advisory committee review and that FDA no, the path for the drug is anything but clear.

Teplizumab remains a priority, but the addition of Sanjuan, who has had stints and Bristol Myers Squibb and Medimmune, also helps more sharply focus the biotech’s work on earlier assets.  

He will also be well versed in a company trying to come back from setbacks: Gossamer lost its CEO and chief scientific officer over the last year amid the fallout from its then leading drug, GB001, failing two midphase studies in asthma and chronic rhinosinusitis, forcing it to rethink its pipeline, management and future focus.

“As we continue to grow as an organization pioneering early interception and prevention of debilitating and life-threatening autoimmune diseases, it is clear we have reached the stage where our novel approach and exciting pipeline of therapeutic candidates represents a compelling career advancement opportunity for seasoned industry experts of the caliber of Miguel,” said Francisco Leon, M.D., Ph.D., CSO and co-founder at Provention Bio.

“As we advance our lead therapeutic candidates in parallel with our ambitions to expand, reinforce, enhance and enrich our immunology-focused pipeline, Miguel’s leadership and expertise will play a critical role in the identification, sourcing and development of new assets and partnerships and we are excited to welcome him to our team.”