Janssen deal gives new kid in town Provention two immune candidates

Drugs for Crohn's and ulcerative colitis are headed for trials next year.

Right on the heels of a $28 million seed financing, Provention Bio has snapped up two inflammatory bowel disease candidates from Janssen that should make it a double clinical-stage biotech next year.

The Lebanon, New Jersey-based startup—headed by biopharma industry veteran Ashleigh Palmer—was set up last quarter to develop new drugs for immune-mediated diseases. It has now brought in a ready-made clinical pipeline by licensing Janssen's small-molecule CSF-1R inhibitor JNJ-40346527 (now PRV-6527) for Crohn's disease, along with ulcerative colitis candidate JNJ-42915925 (PRV-300), an anti-TLR3 antibody, to add to its existing program focusing on a vaccine for type 1 diabetes.

Palmer said the company intends to start a phase 2a trial of PRV-6527 in Crohn's and a phase 1/2 trial of PRV-300 in ulcerative colitis in the first half of next year.

The two candidates "are de-risked phase 2 assets with an established proof-of-mechanism in clinical trials, excellent manufacturing, toxicology, pharmacokinetic, biomarker and animal model packages from Janssen," Palmer told FierceBiotech, adding that they also have the potential to be "first-in-class candidates, with little competition, and great mechanistic potential in diseases of high unmet need."

"Importantly, the CSF-1R asset is an oral medication, and there is not yet one approved for moderate-severe Crohn's at this time," he continued. "Additionally, our TLR3 mAb has excellent potential for personalized medicine for ulcerative colitis and expansion into emerging viral diseases and severe influenza."

The deal with Janssen—whose parent Johnson & Johnson contributed to Provention's first-round funding—accelerates the company's move to the clinic, and it may not stop there. Palmer says it could add to its pipeline with additional deals in the next 12 to 18 months, and will also consider additional financing in that period to facilitate those, as well as completing its executive team.

Its coxsackievirus B (CVB) vaccine program targeting the prevention or delay of Type 1 diabetes onset, also licensed in (from Finnish biotech Vactech), is heading for trials but the company still needs to find a manufacturing partner for clinical trial supplies, something Palmer thinks should be done "in the near future".

"Once clinical supply has been produced, we will be able to initiate and complete toxicology studies and file our clinical trial application," he said. Research has suggested that CVB infection could be a trigger for more than half of the Type 1 diabetes cases worldwide, according to Provention.

While the diabetes program is pretty high-risk, the Janssen deal gives Provention candidates with mechanisms that have been put through the wringer by researchers and have a growing body of evidence supporting their value in immune diseases.

"There is an increasing understanding that reduction in inflammatory gene expression and improvement in tissue damage, as evidenced by histological improvement and mucosal healing, precedes clinical improvement," said Palmer, who noted that the company intends to test that by various means including gene signatures, tissue histology on biopsy and mucosal damage on endoscopy, as well as more traditional clinical endpoints.

"Provention's emphasis on these early outcome measures serves as an important foundation for our 'rapid go/no-go' clinical trial design," he said.