GlaxoSmithKline (GSK) has entered into a global strategic collaboration with the Merck group for an immunotherapy candidate M7824 (bintrafusp alfa) in difficult-to-treat cancers.
As part of the deal, which is valued at approximately €3.7bn ($4.2bn), the companies will jointly develop and commercialise the product for multiple indications.
M7824 is Merck’s investigational bifunctional fusion protein compound that acts simultaneously on transforming growth factor-β (TGF-β) trap and an anti-programmed cell death ligand-1 (PD-L1).
Both TGF-β and PD-L1 are immuno-suppressive pathways used by tumours to avoid the body’s immune system. Targeting these pathways is expected to control tumour growth.
The immunotherapy candidate is currently in clinical development as a monotherapy and in combination with other GSK and Merck products.
Eight immuno-oncology studies are ongoing or set to be initiated this year, including trials for non-small cell lung and biliary tract cancers.
GSK chief scientific officer and R&D president Hal Barron said: “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.
“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.”
Under the terms of the alliance, Merck will receive an upfront payment of €300m from GSK, along with up to €500m in potential development milestones triggered by data from the lung cancer programme.
Merck is additionally eligible for up to €2.9bn based on future approval and commercial milestones. The partners will equally share all profits and costs on a global basis.
Merck Healthcare CEO Belén Garijo 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.
“We now look forward to harnessing the full potential of M7824 across a broad range of cancer indications as we continue to advance our oncology portfolio.”
The partnership is in line with Merck’s oncology R&D strategy aimed at advancing its clinical stage assets, while GSK expects to boost its pharmaceuticals pipeline.
GSK recently acquired US-based oncology-focused biopharmaceutical company Tesaro to strengthen its pharmaceutical business.