Company aims to start Phase I trials with lead candidate in cancer patients next year.

Amplimmune will receive a $23 million up-front payment from GlaxoSmithKline (GSK) as part of a broad collaboration centered on developing PD-1-targeting therapeutics against cancer and other diseases. The agreement gives GSK exclusive, worldwide rights to AMP-224 and any new next-generation fusion proteins targeting PD-1. Amplimmune could receive up to $485 million in regulatory, development, and sales milestones plus sales royalties.

GSK separately inked a deal with Five Prime focused on skeletal muscle disorders. The firm paid $15 million up front and additional fees of $124 million over and above research funding in 2011 and 2013.

Amplimmune’s AMP-224 is an Fc-fusion protein designed to block interaction between PD-1 and B7-H1 to overcome immune suppression and allow the immune system to fight cancer and chronic infections. Amplimmune says it expects to start Phase I trials with AMP-224 in cancer patients next year. The firm is also working to complete cGMP manufacturing and toxicology studies to support progression of AMP-224 into the clinic.

The two partners will in addition work together to define the mechanism of action of AMP-224 and evaluate the fusion protein’s potential utility in oncology, infectious diseases, and vaccine applications. Excluding the Phase I trial with AMP-224, GSK will be responsible for all other development and manufacturing activities associated with product development.

Amplimmune is focused on the development of immune-based biologics for treating cancer, autoimmunity, transplantation-related disorders, and infectious diseases. The firm’s platform, originally developed by its founders at Johns Hopkins University, centers on immunological checkpoint and co-stimulatory molecules as the basis for developing treatments that modulate critical mechanisms in the body’s immune system. A mouse version of AMP-224 has already shown promising activity in mouse models of cancer and infectious disease, Amplimmune claims.

In addition to AMP-224, the Amplimmune pipeline includes another preclinical-stage candidate, AMP-110, for the treatment of autoimmune diseases. AMP-110 targets T cells and is designed to elicit a co-inhibitory signal that suppresses T-cell responses.

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