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The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
GlaxoSmithKline (GSK) and Merck KGaA announced on Feb. 5, 2019 that they have entered into a global strategic alliance to jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy, M7824 (bintrafusp alfa), in a deal potentially worth up to EUR 3.7 billion (US$4.2 billion).
Under the agreement, Merck KGaA will receive an upfront payment of EUR 300 million (US$340 million) and is eligible for potential development milestone payments of up to EUR 500 million (US$566 million) triggered by data from the M7824 lung cancer program. Merck KGaA will also be eligible for further payments from GSK of up to EUR 2.9 billion (US$3.3 billion) upon successfully achieving future approval and commercial milestones. The total potential deal value is up to EUR 3.7 billion US$4.2 billion). Both companies will jointly conduct development and commercialization, and all profits and costs from the collaboration will be shared equally on a global basis.
Bintrafusp alfa is the proposed International Nonproprietary Name (INN) for M7824; it is currently not approved for any use anywhere in the world. The candidate is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers. This includes a Phase II trial to investigate use of the drug as a first-line treatment in patients with programmed cell death ligand-1 (PD-L1) expressing advanced non-small cell lung cancer (NSCLC), compared to treatment with pembrolizumab.
Pembrolizumab is the active component in Merck & Co’s Keytruda, which made more than $7 billion in sales in 2018.
M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β (TGF-β) trap and an anti-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, according to the companies. M7824 has the potential to offer new ways to address difficult-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 assets from the pipelines of both companies.
“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,” said Hal Barron, chief scientific officer and president of R&D, GSK, in a company press release.
This alliance further strengthens GSK’s pharmaceuticals pipeline, following on the heels of the company’s recent $5.1-billion acquisition of Tesaro, an oncology-focused company based in Waltham, MA, in January 2019. GSK’s approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics and, most recently, genetic medicine.