September 21, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Lebanon, NJ – Provention Bio has signed a deal with Janssen Pharmaceutica NV and Janssen Sciences Ireland UC, both Johnson & Johnson companies to in-license two clinical-stage assets for immune-mediated diseases.
The first asset, PRV-6527, is an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor. Provention Bio plans to head into a Phase IIa proof-of-concept trial with the compound in Crohn’s disease. It expects to begin enrollment in the first half of next year.
“The CSF-1R pathway is overrepresented in Crohn’s disease gut tissue, and unpublished data suggest a potential beneficial effect of PRV-6527 on Crohn’s-like disease in mouse models,” said Francisco Leon, scientific co-founder of Provention Bio, in a statement. “Our goal with the Phase IIa PoC study is to confirm this observation in patients with moderate to severe Crohn’s disease, who are still substantially underserved by conventional therapeutics. In particular, there is no oral medication approved for the treatment of moderate to severe Crohn’s patients at this time.”
The second asset, PRV-300, is an anti-Toll-Like Receptor 3 (TLR3) monoclonal antibody. The company plans to study the compound in a Phase I/II proof-of-mechanism, proof-of-concept study in moderate-to-severe ulcerative colitis (UC). Provention also expects to begin enrollment in the first half of 2018. This drug is also to be evaluated for additional indications, including severe influenza and emerging viral diseases.
“We know that PRV-300 suppresses the effects of viral infections and inflammation in animal models,” said Eleanor Ramos, the company’s chief medical and chief operating officer, in a statement. “While our initial trials will target the demonstration of PoM in human patients with moderate to severe UC, we also intend to explore life-cycle expansion opportunities, including severe influenza in the hospital setting, as well as emerging viral diseases.”
In April, Provention announced a $28.4 million financing round, which also had significant investment from J&J.
John Carroll, writing for Endpoints News, notes, “Provention Bio is run by three key execs: CEO Ashleigh Palmer, CMO Eleanor Ramos and scientific co-founder Francisco Leon. Palmer and Leon had already set up Celimmune, which is devoted to advancing a new drug for Celiac disease, which they got from Amgen . And Leon, a former researcher at J&J, has direct experience with the two drugs they’re picking up from J&J for their new company.”
PRV-6527 may also be evaluated in irritable bowel syndrome (IBD). The company previously in-licensed an enterovirus vaccine platform, which the company plans to develop for the prevention or delayed onset of type 1 diabetes by vaccinating at-risk populations against Coxsackievirus B (CVB). CVB infection is believed to be responsible for more than half of type 1 diabetes cases globally.
“The in-licensing of PRV-6527 and PRV-300 from Janssen continues to build momentum following our corporate launch last quarter and advances our strategic intent to source clinical-stage programs targeting the interception or prevention of immune-mediated diseases,” Palmer said in a statement. “Moreover, these two transactions showcase Provention’s ability to leverage its expertise in translational medicine and ‘rapid go/no-go’ clinical trial design to acquire or in-license well-studied and characterized clinical-stage assets in the field of immune-mediated disease.”
No financial details about the deals were released. In April, when Provention announced its first financing, there was talk of a possible initial public offering (IPO) in 2018, but Palmer told Carroll that the company plans to focus on its three assets and will make a decision about future financing once hard data is created.
