GlaxoSmithKline (GSK) and Merck KGaA have entered into a global strategic alliance, worth up to $4.2 billion, to jointly develop and commercialize M7824 (bintrafusp alfa), an investigational bifunctional fusion protein immunotherapy for treating multiple cancers.

Under the agreement, Merck KGaA will receive an upfront payment of EUR 300 million ($341 million) and is eligible for potential development milestone payments of up to EUR 500 million ($568 million) triggered by data from the M7824 lung-cancer program. Merck KgaA will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to EUR 2.9 billion ($3.3 billion). The total potential deal value is up to EUR 3.7 billion ($4.21 billion). Both companies will jointly conduct development and commercialization with all profits and costs from the collaboration being shared equally on a global basis.

For GSK, this alliance is a further step in the company’s priority to strengthen its oncology pipeline. The company acquired Tesaro, a Waltham-based oncology-focused pharmaceutical company in January 2019 for $5.1 billion. GSK says it is focused on several areas in oncology: immuno-oncology, cell therapy, cancer epigenetics, and genetic medicine.

M7824 is in a Phase II study as a monotherapy in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCL) and is in Phase I studies for evaluating its use with solid tumors. M7824 is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein, according to information from the companies.

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. 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. In total, eight immuno-oncology clinical development studies are ongoing or expected to begin in 2019, including studies in NSCL and biliary tract cancers.

Source: GlaxoSmithKline and Merck KGaA