Japan-based Daiichi Sankyo and Amplimmune, a Gaithersburg, Md.-based developer of novel co-stimulatory/co-inhibitory molecules that rebalance the immune system,  have entered into a broad strategic collaboration to develop a new therapeutic protein, AMP-110 (B7-H4 fusion protein). 

The collaboration will focus on development of AMP-110, a potential immune modulation therapy for autoimmune diseases. This proprietary, first-in-class biologic works by blocking inflammatory T cell differentiation. The parties expect to initiate a phase I clinical study for the compound for the treatment of an autoimmune disease indication in the first half of 2013.

Daiichi Sankyo will pay Amplimmune an undisclosed option fee and provide more than $50 million to reimburse past and planned R&D costs for AMP-110 including funding for future development through a phase II, POC study. Amplimmune also will be eligible to receive additional program milestone payments during the collaboration period. Through the POC study, Daiichi Sankyo will have an exclusive option to acquire the AMP-110 program.

Amplimmune will be responsible for manufacturing clinical supplies, regulatory filings and conducting clinical trials through a POC study in autoimmunity. Amplimmune and Daiichi Sankyo expect to collaborate on research to further elucidate the characteristic of AMP-110 and to identify potential biomarkers to predict patient response to AMP-110. If Daiichi Sankyo exercises its exclusive option to acquire the AMP-110 program, then following such acquisition, Daiichi Sankyo will be solely responsible for all future development, manufacturing and commercialization.

"We are very pleased to be collaborating with Daiichi Sankyo on AMP-110," said Michael S. Richman, president and CEO of Amplimmune. "This unique transaction allows Amplimmune to collaborate with an important and well-respected partner and positions the program for an acquisition that will provide significant value for both Daiichi Sankyo and our shareholders."