Provention Bio Announces Licensing Agreements with Janssen

Provention Bio has entered into agreements with Janssen Pharmaceutica NV and Janssen Sciences Ireland UC [Janssen] to in-license two clinical-stage assets, PRV-6527 (JNJ-40346527), an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor, and PRV-300 (JNJ-42915925/CNTO 3157), an anti-Toll-Like Receptor 3 (TLR3) monoclonal antibody.

PRV-6527 will be studied in a Phase 2a proof-of-concept (PoC) clinical trial in Crohn's disease, for which Provention anticipates initiating enrollment in the first half of 2018. PRV-300 will initially be evaluated in a Phase 1/2 proof-of-mechanism (PoM), PoC study in moderate-to-severe ulcerative colitis (UC), which Provention expects to also initiate in the first half of 2018. PRV-300 also has the potential to target additional indications, including severe influenza and emerging viral diseases.

The addition of PRV-6527 and PRV-300 expands Provention's drug development pipeline to three in-licensed programs, including the previously announced enterovirus vaccine platform, which Provention is developing to potentially prevent or delay the onset of type 1 diabetes (T1D) by vaccinating at-risk populations against Coxsackievirus B (CVB) infection. Research suggests that CVB infection could be responsible for more than half of T1D cases worldwide.  

Provention was launched in the second quarter of 2017 to reduce the high morbidity, mortality, patient suffering, and escalating costs of debilitating autoimmune and inflammatory diseases by developing drugs and technologies that intervene before the targeted disease begins, re-appears or progresses. Provention obtained a $28.4 million founding financing in April 2017.

"The in-licensing of PRV6527 and PRV300 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," Ashleigh Palmer, co-founder and CEO of Provention Bio, said. "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."