A week after announcing its founding, the fledgling immunotherapy developer Celimmune said today it has exclusively licensed from Amgen its Phase II candidate AMG 714, with plans to develop the anti-IL-15 monoclonal antibody as a treatment for diet nonresponsive celiac disease and refractory celiac disease (RCD).

The value of the deal and other financial terms were not disclosed.

Under its exclusive license agreement, Celimmune said, it had rights to develop, manufacture, and commercialize AMG 714 worldwide except Japan. The deal also grants Amgen an exclusive option to reacquire AMG 714, upon completion of additional clinical studies.

Celimmune said it plans to launch Phase II studies of AMG 714. In a statement, Francisco Leon, M.D., Ph.D., Celimmune's CEO and chief medical officer, said the trials will allow the company to test whether IL-15 plays a central role in RCD, also known as celiac disease-triggered T-cell lymphoma, and nonresponsive celiac disease.

According to Dr. Leon, IL-15 appears to be an essential, nonredundant, growth factor for those intraepithelial lymphocytes that cause intestinal mucosal atrophy and pathological progression to lymphoma in RCD. IL-15 has been shown to be one of the key factors in the loss of tolerance to food antigens, and also is believed to be involved in Crohn's disease and other autoimmune diseases.

Celimmune may look to develop AMG 714 for indications beyond celiac disease: “In addition to celiac, AMG 714 could have longer-term expansion and life cycle management opportunities within adjacent gastrointestinal autoimmune diseases,” added Ashleigh Palmer, Celimmune's executive chairman.

AMG 714 was originally in-licensed by Amgen from Genmab, and developed for rheumatoid arthritis and psoriasis until development was discontinued in 2008 following disappointing results in clinical studies.

Celimmune disclosed its agreement to develop AMG 714 just a week after announcing it had been launched. Palmer will continue as president of Creative BioVentures™, a strategic advisory firm serving the biopharma industry. Dr. Leon joined Celimmune from Johnson & Johnson's Janssen Pharmaceuticals, formerly Centocor, where he was vp and head of translational medicine and led the company's early-stage clinical development in immunology.

Dr. Leon also noted that there are no approved therapies being marketed for Celiac disease—though several developmental programs are in progress from other drug developers.

Just last month, the journal Gastroenterology published results of a Phase IIb study announced last year showing Alba Therapeutics’ compound Larazotide acetate reduced signs and symptoms in 342 celiac disease patients on a gluten-free diet better than a gluten-free diet alone. And in December, ImmusanT raised $12 million in Series B financing from Vatera Healthcare Partners to advance its immunotherapy, Nexvax2®, a companion diagnostic and a standalone, blood-based diagnostic for celiac disease.

In November 2013, for example, GlaxoSmithKline and Avalon Ventures launched Sitari Pharmaceuticals with $10 million in Series A financing and R&D support from the partners. Sitari is targeting the Transglutaminase 2 (TG2) pathway to develop treatments for multiple disease indications, with an initial focus in celiac disease.

Also in 2013, AbbVie and Alvine Pharmaceuticals launched a launched a $70 million-upfront celiac treatment partnership based on developing ALV003, consisting of two recombinant, gluten-specific enzymes—a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP).

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