Amgen and Provention Bio, Inc., a clinical-stage biopharmaceutical company focused on immune-mediated diseases, have entered a licensing and co-development agreement for AMG 714, identified by Provention as PRV-015. AMG 714 is a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease (NRCD). Development efforts at Provention will be led by researchers with previous experience developing AMG 714.
Under the terms of the agreement, Provention will conduct and fund a Phase 2b trial in NRCD and lead the next phase of development and regulatory activities for the program. Amgen will make a $20 million investment coincident with Provention’s next financing event, subject to certain terms and conditions. Amgen is also responsible for the manufacturing of AMG 714. Upon completion of the Phase 2b trial, Provention will be eligible to receive a $150 millionmilestone payment, as well as additional regulatory milestone payments and royalties if Amgen continues AMG 714 development.
“Celiac disease impacts millions of people around the world and remains the only common autoimmune disease with no approved therapeutic treatment,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased to collaborate with Provention, given their expertise and familiarity with AMG 714, in advancing a potential new treatment option for patients living with this life-interrupting illness.”
“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 Ashleigh Palmer, co-founder and chief executive officer of Provention.
“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 non-responsive celiac disease and RCD-II,” said Francisco Leon, M.D., Ph.D., co-founder and chief scientific officer of Provention. “We are delighted to be collaborating with Amgen to advance AMG 714 by way of the planned Phase 2b NRCD study.”
About AMG 714
AMG 714 (PRV-015) is a human immunoglobulin monoclonal antibody that binds to IL-15. AMG 714 was initially developed by Amgen in rheumatoid arthritis and later investigated for possible use in celiac disease. In 2015, Amgen outlicensed AMG 714 to Celimmune LLC, a clinical development-stage immunotherapy company founded by Ashleigh Palmer and Francisco Leon, M.D., Ph.D. Celimmune conducted two separate AMG 714 Phase 2a clinical trials in celiac disease and refractory celiac disease type II, after which Amgen acquired Celimmune in 2017.
Data from both clinical trials were presented at Digestive Disease Week 2018.
Filed Under: Drug Discovery and Development