Merck KGaA

GlaxoSmithKline has signed a wide-reaching deal worth up to £3.2bn with German pharma giant Merck KGaA for the rights to a new type of immunotherapy for various difficult-to-treat cancers.

Both companies have unveiled their intentions to develop and commercialise novel immunotherapy M7824 (bintrafusp alfa).

M7824 is a bifunctional fusion protein currently undergoing examination in numerous trials including a phase II head-to-head against blockbuster Keytruda (pembrolizumab) as a first-line treatment in patients with PD-L1 expressive advanced non-small cell lung cancer (NSCLC).

The companies have stated that the drug is going to be studied both as a monotherapy as well as an adjunctive.

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.

To-date nearly 700 patients have been treated with M7824 in over 10 tumour types in phase I studies. The data currently collected has been extremely encouraging and pre-clinical studies have shown superior anti-tumour activity compared with anti-PD-L1 alone.

Additionally both companies announced there will be a total of eight high priority studies ongoing or commencing by 2019.

Further information about the deal shows that Merck KGaA will recieve an upfront payment of £260m and is eligible for potential development milestone payments of up to £440m triggered by data from the M7284 lung cancer programme. Merck KGaA will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to £2.5bn. The total potential deal value has been calculated at £3.2bn.

Dr Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck KGaA, Darmstadt, Germany 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. GSK clearly emerged as the ideal partner due to their strong commitment to oncology, and the complementary talent and capabilities they will bring to our alliance. 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.”