GlaxoSmithKline signs deal with Amplimmune worth more than $500 million for AMP-224 in cancer and other diseases

US biotechnology firm Amplimmune, a four-year old spin-off from Johns Hopkins University, announced yesterday that it has entered into a broad strategic alliance with UK drugs giant GlaxoSmithKline 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 deal, GSK will pay Amplimmune a non-refundable upfront of $23 million. The latter is eligible to receive up to $485 million in regulatory, development and sales milestones - including milestones associated with Investigational New Drug filing and conducting a Phase I 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 AMP224 suggest that this product candidate can induce immune responses to tumors and pathogens sufficient to ameliorate disease. Under the terms of the accord, Amplimmune will be responsible for conducting a Phase I 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.