New Jersey Startup Celimmune Aims to Give New Life to Shelved Amgen Drug

Published: Mar 04, 2015

New Jersey Startup Celimmune Aims to Give New Life to Shelved Amgen (AMGN) Drug
March 2, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Lebanon, N.J.-based Celimmune said Monday it will attempt to resurrect long-dormant celiac disease drug AMG 714 after purchasing the Phase II-stage, anti-IL-15 monoclonal antibody from the company for an undisclosed amount, saying that a gluten-free diet is not enough to treat patients that have Celiac.

"Celiac disease is the only common autoimmune disease without any approved medication. Published literature demonstrates that the gluten-free diet is not a solution for the vast majority of patients,” said Francisco Leon, Celimmune's CEO and chief medical officer, in a statement.

Patients with Celiac disease suffer from a chronic hereditary systemic autoimmune and inflammatory condition triggered by eating gluten, which then damages the lining of the small intestine, causing pain and a constellation of uncomfortable symptoms in the GI tract.

Thousand Oaks, Calif.-based Amgen shelved AMG 714 in 2008 after its trials using it to treat rheumatoid arthritis and psoriasis didn’t appear to poised to compete with a higher standard of care provided by competitors. But those trials did show that patients treated saw a 20 percent improvement of Celiac-type symptoms in 60 percent of the patients in a 280-patient study--data that has made Celimmune decide to buy the drug in the hopes of revamping it as a new TNF candidate.

Leon said that Celimmune is “delighted” to license an experimental therapeutic that will test one of the main hypotheses in the pathophysiology of celiac disease, namely that IL-15 plays a central role in RCD and non-responsive celiac disease.

“IL-15 appears to be an essential, non-redundant, growth factor for those intraepithelial lymphocytes that cause intestinal mucosal atrophy and pathological progression to lymphoma in RCD,” said Leon. “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."

The idea that old drugs can be given new lives is a perennial favorite in the world of biotech, where effective therapies can often be stumbled on only as peripheral perks when a study or trial falls through. It has also worked in the past for other companies, wrote Ben Fidler, a columnist at Xconomy.

“Other startups have succeeded with similar strategies. Atlas Ventures, for instance, formed Arteaus Therapeutics in 2011 to take a molecule from Eli Lilly and Company for migraines, generate proof of concept, and sell it back,” wrote Fidler. “Stromedix similarly took a shelved fibrosis drug from Biogen Idec , advanced it, and thenflipped it back to its old owner. The difference with Celimmune is it aims to stay independent and do these types of deals more than once.”

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