Daiichi Sankyo and Amplimmune Announce Strategic Alliance to Develop AMP-110
Therapy for Autoimmune Disease
Provides for AMP-110 program acquisition by Daiichi Sankyo following "Proof of
TOKYO and GAITHERSBURG, Maryland, Jan. 7, 2013
TOKYO and GAITHERSBURG, Maryland, Jan. 7, 2013 /PRNewswire/ --Daiichi Sankyo,
Co., Ltd. (hereafter, Daiichi Sankyo) and Amplimmune, Inc. (hereafter,
Amplimmune) announced today 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
"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
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.
About Amplimmune, Inc.
Founded in 2007 and headquartered in Gaithersburg, MD, Amplimmune is focused
on developing novel co-stimulatory/co-inhibitory molecules that rebalance the
immune system and are intended for treating cancer, autoimmune disease,
infectious disease, and transplantation. With its strong product-based focus,
Amplimmune has rapidly developed three biologic product candidates: AMP-224 is
in Phase 1b trials in cancer in collaboration with GlaxoSmithKline; AMP-110
for autoimmune diseases in partnership with Daiichi Sankyo; and AMP-514 for
cancer. Working closely with its collaborators, Amplimmune is expanding its
technology base in the area of immune co-stimulatory/co-inhibitory molecules
and has assembled a large foundation of reagents, models, know-how, and
intellectual property to further develop its product pipeline as well as to
discover novel biomarkers, ligands, and receptors. The company is funded by
InterWest Partners and The Wellcome Trust. For more information, please visit
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical products to address the diversified, unmet medical needs of
patients in both mature and emerging markets. While maintaining its portfolio
of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial
infections, the Group is engaged in the development of treatments for
thrombotic disorders and focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has
created a "Hybrid Business Model," which will respond to market and customer
diversity and optimize growth opportunities across the value chain. For more
information, please visit www.daiichisankyo.com.
Contact: Gary Fanger, Ph.D., Amplimmune, Inc., +1-301-309-9800,
firstname.lastname@example.org; or Daiichi Sankyo Co., Ltd., +81-3-6225-1126
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