Getting AMP-ed up

TOKYO—A broad strategic collaboration was announced earlylast month between Daiichi Sankyo Co. Ltd. and Amplimmune Inc. for thedevelopment of AMP-110, a therapeutic protein from Amplimmune being developedas a potential immune modulation therapy for autoimmune diseases.

Per the terms of the agreement, Daiichi Sankyo will pay anoption fee of an undisclosed amount as well as more than $50 million toreimburse past and planned research and development costs for the compound,including funds for future development through a Phase II proof-of-conceptstudy. In addition, Amplimmune will be eligible to receive milestone paymentsduring the collaboration. Amplimmune's responsibilities will includemanufacturing clinical supplies, handling regulatory filings and conducting clinicaltrials through the proof-of-concept study. Both companies expect to collaborateon further research into the mechanism of AMP-110 and identification ofbiomarkers that could predict response to the compound. Through the study,Daiichi Sankyo will have an exclusive option to acquire AMP-110. Should theoption be exercised, Daiichi Sankyo will have sole responsibility for allfuture development, manufacturing and commercialization.

"We are very pleased to be collaborating with Daiichi Sankyoon AMP-110," Michael S. Richman, president and CEO of Amplimmune, said in apress release. "This unique transaction allows Amplimmune to collaborate withan important and well-respected partner and positions the program for anacquisition that will provide significant value for both Daiichi Sankyo and ourshareholders."

AMP-110 targets the B7-H4 pathway, which is believed to playa significant role in maintaining tolerance and controlling inflammation byinhibiting T cell-mediated inflammatory reactions. AMP-110 has been designed tomimic B7-H4's natural ability to induce a co-inhibitory pathway that reducesinflammatory T cells, and the compound has demonstrated potency in animaldisease models. Daiichi Sankyo and Amplimmune intend to begin a Phase Iclinical study of AMP-110 for the treatment of an undisclosed autoimmunedisease indication sometime in the first half of this year.

Dr. Gary Fanger, senior vice president and chief operatingofficer at Amplimmune, says that Daiichi Sankyo emerged as an ideal partner formoving the AMP-110 program forward, a "very committed partner interested inhelping to develop drugs that expand the course of medicine for patients withautoimmune disease."

"They had a very strong visionary component to theirthinking related to drug development in the autoimmune space, and thatcorrelated well with our perspectives, because this AMP-110 drug has a verynovel mechanism of action," says Fanger. "And in talking with them and theirscientific group and their clinical group, we really liked the alignment aroundthe possibility of developing drugs with novel mechanisms of action. So theyhad a wealth of creativity around drug design that we really liked."

Thanks to the novelty of AMP-110's mechanism of action, theprogram is thought to have the potential to treat a wide range of autoimmunediseases, to the point that Fanger says one of the toughest challenges was tonarrow in on an indication. In considering potential markets and unmet medicalneed, Fanger says the areas they are most interested in exploring with AMP-110are rheumatoid arthritis, lupus, multiple sclerosis and Sjögren's syndrome.

A company spokesman from Daiichi Sankyo notes that the company expects AMP-110 "to be a first-in-class drug with a highly novel mechanism of action," adding that "it fits well into the Daiichi Sankyo R&D strategy for pursuing innovation in frontier areas."

Fanger adds that this partnership represents the first timethe two companies have worked together, and calls it a good fit forAmplimmune's growth strategy. The option asset buyout approach of thispartnership, he says, allows Amplimmune to balance its needs and the needs ofpharma companies, and helps "to ultimately accelerate returns for ourinvestors." The company is considering additional partnerships along this sameformat for the other biological therapeutics in its pipeline.

"This collaboration strengthens our commitment to workingwith partners that are at the forefront of science," Dr. Glenn Gormley, globalhead of R&D and senior executive officer of Daiichi Sankyo, said in astatement. "Immune modulation therapy is one of the exciting areas ofautoimmune disease research that has the potential to meet an unmet medicalneed. As a global pharma innovator, identifying and meeting unmet medical needsis an important part of Daiichi Sankyo's mission. We are excited to start withthe first trial."