A week after first raising the flag on their newborn biotech, a pair of entrepreneurs unhatched a deal today to take down a drug program that has been gathering dust on Amgen's ($AMGN) R&D shelves for the past 7 years and test it as a new treatment for celiac disease.
The drug is AMG 714, a midstage therapy originally in-licensed from Genmab that Amgen says proved effective (and safe) in treating rheumatoid arthritis but failed to distinguish itself from the remedies that were available back in 2008 when they iced the treatment. Now tiny Celimmune, which is staffed by its two founders--Francisco Leon and Ashleigh Palmer--have a deal to put it into Phase II for cases of celiac disease that don't respond to the only currently available treatment method: diets that strictly exclude gluten. And depending on the data they get, Amgen can buy it back.
Nobody, though, is talking about any of the dollars involved, at least at this stage of the game, for the newly formed Celimmune.
According to the Celiac Disease Foundation, about 1 in 100 people have the disease, a genetic condition in which gluten triggers an autoimmune attack on the small intestines that can cause intense suffering among the people who have it. Generally, it's responsive to strict dietary controls, though Celimmune's founders say that diet is not a solution for most patients. And now the biotech will follow the IL-15 pathway, which has been highlighted in preclinical research as a promising target for this disease, to see if they can prove they have a therapy for unresponsive patients at risk of developing lymphoma.
"Celimmune is delighted to have an opportunity 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 (refractory) and non-responsive celiac disease," says Leon, the CEO and CMO of the virtual group, in a statement. "IL-15 appears to be an essential, non-redundant, growth factor for the intraepithelial lymphocytes, which cause intestinal mucosal atrophy and the 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 in celiac disease, and also is believed to be involved in Crohn's disease and other autoimmune diseases."
Leon's resume includes a stint at J&J's Janssen and Alba Therapeutics, where he was CMO. He has also held various positions in clinical research at Bristol Myers-Squibb and MedImmune/AstraZeneca.
Celimmune is correct in saying that there are no drugs for the condition, but with the number of cases of gluten intolerance on the rise in the U.S. there are several other programs in development. ImmunsanT raised a $12 million venture round for its therapeutic vaccine late last year. GlaxoSmithKline and Avalon teamed up last year to launch Sitari to develop new celiac drugs while AbbVie partnered with Alvine Pharmaceuticals back in 2013.