Daiichi Sankyo and Amplimmune announce strategic alliance to develop AMP-110 therapy

Daiichi Sankyo, Co., Ltd. (hereafter, Daiichi Sankyo) and Amplimmune, Inc. (hereafter, Amplimmune) announced that they 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 1 clinical study for the compound for the treatment of an autoimmune disease indication in the first half of 2013.

Under the terms of the agreement, Daiichi Sankyo will pay Amplimmune an undisclosed option fee and provide more than $50 million to reimburse past and planned research and development costs for AMP-110, including funding for future development through a Phase 2 (Proof of Concept Study, hereafter, 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.

Under the terms of the agreement, 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.

“This collaboration strengthens our commitment to working with partners that are at the forefront of science” said Glenn Gormley, MD, PhD, global head of R&D, senior executive officer of Daiichi Sankyo. “Immune modulation therapy is one of the exciting areas of autoimmune disease research that has the potential to meet an unmet medical need. As a Global Pharma Innovator, identifying and meeting unmet medical needs is an important part of Daiichi Sankyo’s mission. We are excited to start with the first trial.”

“We are very pleased to be collaborating with Daiichi Sankyo on AMP-110” said Michael S. Richman, Amplimmune’s President and Chief Executive Officer. Richman continued, “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.”

About B7-H4 and AMP-110

The B7-H4 pathway is believed to play a key role in maintaining tolerance and controlling inflammation. B7-H4, first identified by Amplimmune scientific founder Dr. Lieping Chen, inhibits T-cell mediated inflammatory reactions. AMP-110, an Fc fusion of the extracellular domain of B7-H4, has been specifically designed to mimic the natural ability of B7-H4 to induce a co-inhibitory pathway that reduces inflammatory T cells known to contribute to autoimmune disease. Published preclinical data demonstrate the potency of AMP-110 to modulate autoimmune disease in a number of animal disease models. Given the fundamental nature of the B7-H4 pathway in balancing immune responses and preventing potential deleterious immune activation, AMP-110 has the potential to treat multiple autoimmune/inflammatory disease indications.