GlaxoSmithKline (GSK) and Merck will develop and commercialize novel immunotherapy to treat multiple cancers, under €3.7bn worth deal.
The M7824 is an investigational bifunctional fusion protein immunotherapy, which is currently under clinical development, including potential registration studies, for multiple difficult-to-treat cancers.
Bintrafusp alfa is said to be the proposed International Nonproprietary Name (INN) for the bifunctional immunotherapy M7824.
The M7824 is an investigational bifunctional immunotherapy designed to aggregate transforming growth factor-β (TGF-β trap) with an anti-programmed cell death ligand-1 (PD-L1) mechanism in one fusion protein.
GSK chief scientific officer and president Dr 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.
As per terms of the deal, Merck will secure an upfront payment of €300m, as well as potential development milestone payments of up to €500m after presenting data from the M7824 lung cancer program.
Merck will also receive up to €2.9bn after achieving future approval and commercial milestones. Both firms will jointly carry out development and commercialization activities, and also share profits and costs equally on a global basis.
The Phase II trial is assessing M7824 against pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC).
Around 700 patients were treated with M7824 across more than 10 tumor types in the ongoing phase I studies.
According to GSK, the data from the ongoing trial shows M7824’s potential safety and clinical anti-tumour activity across multiple types of difficult-to-treat cancers such as advanced NSCLC, human papillomavirus-associated cancers, biliary tract cancer (BTC) and gastric cancer.
Merck Healthcare CEO and executive board member Dr 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.