Merck KGaA’s drug candidate is M7824, an investigational bifunctional fusion protein immunotherapy, which is designed to target the transforming growth factor-β (TGF-β) trap and anti-programmed cell death ligand-1 (PD-L1) pathways.
Targeting the PD-1/L1 pathway has become a popular approach in immuno-oncology, with a number of the larger pharma companies bringing their own version of the immunotherapy treatment to market.
GSK does not currently have such a drug in its portfolio but, should the bifunctional approach prove successful, it could jump to the head of the queue on the next generation of such treatments.
GSK is paying €300m ($342m) up-front and has tied in a further €3.4bn in development and commercial milestones to bolster the deal.
M7824 is already progressing through the clinic, with a Phase II trial to investigate the treatment compared with Keytruda (pembrolizumab) in patients with PD-L1 expressing advanced non-small cell lung cancer as a first-line treatment.
GSK noted the aim is for the treatment to prove more effective than individual therapies or combinations of individual therapies, with the latter option being explored in the first wave of PD-1/L1 checkpoint inhibitors.
If the drug candidate is able to prove greater efficacy alone in the Phase II trial, the treatment could stand in line to reap a healthy level of sales. Keytruda, owned by MSD (known as Merck in North America), brought in $2.12bn ($1.86bn) in sales after recently announced fourth-quarter results.
Belén Garijo, Healthcare CEO of Merck KGaA, 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.”
GSK’s ‘strong commitment’ to oncology has been a recent strategy change, after it had previously divested that part of its portfolio to Novartis in 2014. However, with oncology being the fastest growing therapeutic area, the company has changed tact under the guidance of relatively new CEO, Emma Walmsley.
Only recently, in December 2018, GSK made another high-profile towards building its oncology pipeline with a $5.1bn deal to acquire Tesaro.