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The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.
On Nov. 5, 2018, Amgen and Provention Bio, a clinical-stage biopharmaceutical company focused on immune-mediated diseases, announced a licensing and co-development agreement for AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease (NRCD).
Under the terms of the agreement, Provention will conduct and fund a Phase IIb 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 IIb trial, Provention will be eligible to receive a $150 million milestone payment as well as additional regulatory milestone payments and royalties if Amgen continues AMG 714 development.
AMG 714, identified by Provention as PRV-015, is a human immunoglobulin monoclonal antibody that binds to interleukin (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, a clinical development-stage immunotherapy company. Celimmune conducted two separate AMG 714 Phase IIa clinical trials in celiac disease and refractory celiac disease type II, after which Amgen acquired Celimmune in 2017. Development by Provention will be led by researchers with previous experience developing the drug.
"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, MD, executive vice-president of R&D at Amgen, in a company press release. "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, in the release.