Provention Bio has licensed a celiac disease drug from Amgen. Under the deal, the New Jersey-based biotech will take over the drug’s development, picking up a $20 million investment from Amgen and, potentially, a $150 million phase 2b payout.
Amgen originally developed AMG 714, a human immunoglobulin monoclonal antibody, for rheumatoid arthritis before testing it out in celiac disease. In 2015, the Big Pharma licensed it to Celimmune, which carried out two phase 2 trials, in celiac disease and refractory celiac disease type 2. The drug returned to the fold when Amgen acquired Celimmune two years later.
There is no specific drug for celiac disease. The standard treatment is a gluten-free diet, which doesn’t work for some patients, who are said to have gluten-free diet nonresponsive celiac disease. Provention will develop AMG 714, now called PRV-015, for these patients. It stands to reap a $150 million milestone payment when it completes a phase 2b trial in this population, according to a statement. After that, Provention will lead the next phase of development and regulatory activities for PRV-015. If Amgen picks the asset up for further development, Provention would be eligible for additional regulatory milestone and royalty payments.
News of the deal sent Provention’s stock up 13% on Monday.
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"Our AMG 714 co-development collaboration with Amgen is a significant milestone in the growth and advancement of Provention. AMG 714 has the potential to be the first FDA-approved treatment for celiac disease and aligns with Provention's mission to prevent and intercept immune-mediated disease," said Provention CEO Ashleigh Palmer in the statement.
"Data presented at Digestive Disease Week 2018 from two phase 2a clinical trials of AMG 714 demonstrated the drug's potential in celiac disease and refractory celiac disease type II (RCD-II), an in situ gastrointestinal T cell lymphoma, and confirmed that IL-15 plays a central role in nonresponsive celiac disease and RCD-II," said Francisco Leon, M.D., Ph.D., Provention's chief scientific officer, in the statement.
The news comes a few months after Provention raised about $63.9 million in its IPO, beating the $50 million goal it set in May.
PRV-015 joins a pipeline of assets acquired or in-licensed for various immune-modulated diseases. Its lead asset is teplizumab, called PRV-031, an anti-CD3 monoclonal antibody acquired from MacroGenics that’s in development for Type 1 diabetes. It’s also got a pair of GI drugs and a Coxsackie virus vaccine in the pipeline to prevent Type 1 diabetes, as well as a second asset from MacroGenics for the treatment of lupus.