Amplimmune, Inc. announced that it has entered into a broad strategic alliance with GlaxoSmithKline (GSK) to further develop PD-1 targeting therapies that may be effective in the treatment of cancer and other diseases. GSK will obtain exclusive worldwide rights to AMP-224 as well as other potential next generation fusion proteins that target PD-1.

Under the terms of this agreement, GSK will pay Amplimmune a non-refundable upfront payment of $23 million. Amplimmune is eligible to receive up to $485 million in regulatory, development and sales milestone payments - including milestones associated with IND filing and conducting a phase 1 trial of AMP-224. Amplimmune may also receive up to double digit royalties on global sales.

The collaboration will focus primarily on development of AMP-224, Amplimmune's Fc-fusion protein of the B7-DC ligand (also known as PD-L2), which targets PD-1. In vivo studies with AMP-224 suggest that this product candidate can induce immune responses to tumours and pathogens sufficient to ameliorate disease.

Under the terms of the agreement, Amplimmune will be responsible for conducting a Phase 1 trial in cancer patients expected to begin in 2011, as well as completing cGMP manufacturing and GLP toxicology studies that support that first time in human study.

Research directed toward understanding the mechanism of action of AMP-224 and its therapeutic potential in oncology, infectious diseases and vaccine applications will be conducted by Amplimmune and GSK as part of the collaboration. In addition, the parties may develop next generation protein fusion candidates that target PD-1. GSK will be responsible for all other development and manufacturing activities and will have worldwide commercialization rights.

"We are very pleased to establish this broad alliance with GSK on our AMP-224 programme," said Michael S Richman, Amplimmune's president and chief executive officer. Richman continued, "This partnership is an example of pharma and biotech companies working together towards a common goal of developing novel therapies for patients with unmet medical need and we look forward to advancing AMP-224 into clinical testing".

PD-1 and its ligands play key roles in regulating T-cell mediated immune responses. High levels of PD-1 on T cells can lead to functional impairment of T cells resulting in ineffective anti-tumour and anti-microbial immunity. Targeting PD-1 on cells with high levels of PD-1 can restore immune function, resulting in tumour eradication and enhanced protection against infection.

Founded in 2007 and headquartered in Rockville, MD, Amplimmune is focused on developing novel biologics that are key co-stimulatory/co-inhibitory molecules that rebalance the immune system and are intended for treating cancer, autoimmune disease, infectious disease, and transplantation.