Provention Bio has filed to raise up to $50 million in its Nasdaq IPO, which will bankroll several clinical programs, including a pair of inflammatory bowel disease assets it picked up from Janssen last fall.
The news comes amid a busy week for the Lebanon, New Jersey-based startup. Provention announced Monday that it picked the Netherlands-based Intravacc to lead product development and manufacturing of clinical trial material for its Coxsackievirus B vaccine (PRV-101), which is being developed to prevent or delay the onset of Type 1 diabetes. On Wednesday, it acquired the rights to two clinical-stage candidates from MacroGenics: teplizumab, known as PRV-031, and PRV-3279.
Provention launched last June with $28.4 million in seed funding and a goal of intercepting and preventing immune-mediated disease.
“Our goal is to do more than merely treat the symptoms of chronic autoimmune and inflammatory diseases, such as Type 1 diabetes, Crohn’s disease and ulcerative colitis,” said Provention CEO Ashleigh Palmer, at the time. “We hope to identify and combat the underlying cause, or trigger, of such diseases before symptoms emerge, and to intercept disease progression and relapse to eliminate or reduce long-term damage and chronic suffering.
If it pulls in the maximum amount, about $8 million will move PRV-031 into a phase 3 trial for early-onset Type 1 diabetes, while about $3 million will let it plan and design a Phase 1b/2a clinical trial for PRV-3279, which is being developed for lupus, according to an SEC filing. This will be a second chance for PRV-031—Eli Lilly licensed the drug for $41 million up front in 2007, but dumped it three years later it flopped in phase 3.
The Janssen assets are Provention’s top priority: “Even if we only raise the minimum amount in the offering, we expect that the net proceeds will be sufficient to complete our ongoing IBD clinical trials,” the company said in the filing.
About $11 million is earmarked for a phase 2a trial of PRV-6527 in Crohn’s disease, while another $4 million will allow the generation of topline data from a phase 1b study of PRV-300 in ulcerative colitis. The pair could potentially become "first-in-class candidates, with little competition and great mechanistic potential in diseases of high unmet need,” Palmer previously told FierceBiotech.
Editor's note: This story was updated to include context around PRV-031/teplizumab.