GlaxoSmithKline (GSK) and Merck have entered into a global strategic alliance to jointly develop and commercialise M7824 (bintrafusp alfa).
M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development for multiple difficult-to-treat cancers.
This includes a Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).
M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1), that are commonly used by cancer cells to evade the immune system.
Bifunctional antibodies aim to increase efficacy above and beyond that achieved with individual therapies or combinations of individual therapies.
M7824 has the potential to offer new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class.
In addition to use as a single agent, M7824 is also being considered for use in combination with other assets from the pipelines of both companies.
“Despite recent medical advances, many patients with difficult-to-treat cancers don’t currently benefit from immuno-oncology therapies leaving them with limited treatment options,” said Hal Barron, Chief Scientific Officer and President R&D, GSK.
“M7824 brings together two different biological functions in a single molecule and we have observed encouraging clinical results in treating certain cancer patients, particularly those people with non-small cell lung cancer.”
Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck, said: “Our bifunctional fusion protein M7824 has the potential to bring new answers to patients living with cancer.
“Together with GSK we aim to drive a paradigm shift in the treatment of cancer as the leader in this novel class of immunotherapies.”
Merck will receive an upfront payment of €300 million and is eligible for potential development milestone payments of up to €500 million triggered by data from the M7824 lung cancer programme.
Merck will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to €2.9 billion.
The total potential deal value is up to €3.7 billion. Both companies will jointly conduct development and commercialisation with all profits and costs from the collaboration being shared equally on a global basis.