GlaxoSmithKline will partner with Merck KGaA, Darmstadt, to co-develop and co-commercialize the cancer immunotherapy candidate M7824 (bintrafusp alfa), through a collaboration that could generate more than €3.7 billion ($4.2 billion) for German Merck.

M7824 is a bifunctional fusion protein immunotherapy designed to simultaneously target two immunosuppressive 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.

M7824 is now in clinical development, including potential registration studies, for multiple difficult-to-treat cancers. Among those studies are a Phase II trial designed to compare M7824 with Merck & Co.’s Keytruda® (pembrolizumab) as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC), and several Phase I studies assessing M7824 in solid tumors.

The companies said eight high priority immuno-oncology clinical development studies involving M7824 are ongoing or expected to commence in 2019, including studies in NSCLC and biliary tract cancer.

Merck KGaA and GSK reason that M7824 could present new ways to fight hard-to-treat cancers beyond the established PD-1/PD-L1 class. In addition to use as a single agent, M7824 is also being considered for use in combination with other pipeline candidates from both companies.

“Drive a Paradigm Shift’

“Together with GSK we aim to drive a paradigm shift in the treatment of cancer as the leader in this novel class of immunotherapies,” Belén Garijo, member of the executive board and CEO Healthcare of Merck KGaA, declared in a statement. “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 agreed to pay Merck KGaA €300 million ($342 million) and is eligible for potential development milestone payments of up to €500 million ($570 million) triggered by data from the M7824 lung cancer program.

Merck KGaA, Darmstadt, Germany will also be eligible for up to €2.9 billion ($3.3 billion) in additional payments tied to achieving future approval and commercial milestones for M7824.

Both companies agreed to jointly conduct development and commercialization, and to share equally on a global basis all profits and costs from the collaboration.

GSK signaled its intent to significantly accelerate the development of its pipeline and commercial capability in oncology in December 2018, when it announced its $5.1 billion acquisition of Tesaro. GSK completed its purchase of the poly ADP ribose polymerase (PARP) inhibitor developer on January 22.

Under CEO Emma Walmsley, who succeeded Sir Andrew Witty as of March 31, 2017, GSK has overhauled its R&D over the past two years. GSK also appointed Hal Baron, MD, GSK’s CSO and president, R&D, who previously served as president of R&D at Calico (California Life Sciences), a Google-backed company launched in 2013.

In its statement announcing the M7824 collaboration today, GSK said that its approach to oncology “is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics and, most recently, genetic medicine.”

“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,” Barron stated. “I’m excited by the potential impact this first-in-class immunotherapy could have on the lives of cancer patients.”

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