After making headlines for his part in the FDA’s painful rupture over Sarepta’s Duchenne approval, news of John Jenkins has been rather slow. But now, the former head of the agency’s Office of New Drugs is stepping out to join the board of a small company just outside Boston.
Jenkins — who spent about 15 years working as the director of OND, overseeing the review of thousands of drug applications — is quite the catch for Corbus Pharmaceuticals. With his extensive regulatory background, it makes sense for companies to be seeking his insight on their boards. But Corbus is the first company board Jenkins agreed to sit on since leaving the FDA in 2017.
The last time we wrote about Jenkins was during the Sarepta debate that divided the FDA a couple years back. Jenkins came out swinging against the approval of Sarepta’s Duchenne muscular dystrophy drug eteplirsen, which now goes by the brand name Exondys 51. The former agency leader sided with top officials at the FDA who said Sarepta never came close to providing clear evidence of efficacy and safety for eteplirsen. He went as far as to go head-to-head with CDER chief Janet Woodcock, essentially accusing her of appearing biased and browbeating reviewers to approve Sarepta’s drug. He eventually lost that battle, and Jenkins retired from the agency months after the debate.
Since departing from the agency, Jenkins has been working at Greenleaf Health, an FDA-focused strategic consulting firm. But this is his first board seat post-OND.
What’s interesting about Corbus?
The company, founded in 2009, is in a Phase III trial testing its drug lenabasum in systemic sclerosis and a Phase IIb trial in cystic fibrosis, among other programs. Its CF trial was the first that used pulmonary exacerbations as its sole primary endpoint, rather than alongside the co-primary endpoint of FEV1, or forced expiratory volume. Unlike other cystic fibrosis meds, lenabasum doesn’t aim to hydrate patients’ mucus or target the genetic mutation behind the disease, which are captured with FEV1. The company is tackling the underlying inflammation instead.
To Jenkins, Corbus checked all the boxes on his list: the drug has an interesting mechanism of action and positive data, it’s going after diseases with unmet need (CF, scleroderma, dermatomyositis, lupus), and there’s potential to treat inflammation in other diseases. In a statement, Jenkins had this to say:
I look forward to working with the board and the company’s senior leadership team to advance the development of new innovative therapies for patients suffering from serious, chronic inflammatory and fibrotic diseases.
Image: John Jenkins. GREENLEAF HEALTH
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