GSK and Merck KGaA Forge $4.2 Billion Global Alliance to Advance Bintrafusp Alfa (M7824), a First-in-Class Bifunctional Immunotherapy for Hard-to-Treat Cancers

VCBeat (WeChat Official Account: vcbeat) has learned that GlaxoSmithKline and Merck KGaA recently announced the signing of a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa), an investigational bifunctional fusion protein immunotherapy. The deal is valued at up to €3.7 billion ($4.2 billion).

Under the agreement, Merck Group will receive a €300 million ($340 million) upfront payment and is eligible for grants of up to €500 million ($566 million) for the M7824 lung cancer program. In addition, Merck Group can receive up to €2.9 billion ($3.3 billion) in funding support from GlaxoSmithKline. The two companies will jointly develop and commercialize new technologies, with profits and costs from the collaborative projects shared equally.

Bintrafusp alfa is the International Nonproprietary Name (INN) for M7824, which is currently in clinical development, including potential registration studies for various hard-to-treat cancers, and has not yet been approved for use. Also in clinical development alongside bintrafusp alfa is a Phase II trial designed to compare bintrafusp alfa as a first-line treatment with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) expressing programmed death-ligand 1 (PD-L1).

Among them, pembrolizumab is a humanized antibody used in cancer immunotherapy. It is an IgG4 isotype antibody that blocks the protective mechanisms of cancer cells, thereby allowing the immune system to destroy them. In 2017, the FDA approved it for any unresectable or metastatic solid tumors with certain genetic abnormalities. Meanwhile, pembrolizumab is also the active ingredient in Keytruda, a product under Merck & Co., which generated over $7 billion in sales in 2018.

M7824 is designed to simultaneously target two immunosuppressive pathways—a transforming growth factor-beta (TGF-β) “trap” and anti-PD-L1—that cancer cells commonly exploit to evade the immune system. According to the company, this bifunctional antibody aims to enhance potency beyond what can be achieved with monotherapies or combinations of individual agents. M7824 holds promise for providing novel therapeutic approaches for hard-to-treat cancers that are refractory to existing PD-1/PD-L1 inhibitors.

“Despite advances in medicine, many cancer patients still do not benefit from immuno-oncology therapies, leaving their treatment options limited. M7824 combines two distinct biological functions within a single molecule, and we have observed encouraging clinical effects in treating certain cancer patients, particularly those with non-small cell lung cancer,” said Hal Barron, Chief Scientific Officer and President of R&D at GlaxoSmithKline, in a company press release.

Following GlaxoSmithKline’s $5.1 billion acquisition earlier this year of Tesaro, a Massachusetts-based oncology company, its agreement with Merck & Co. will further broaden the company’s pharmaceutical pipeline. In addition, GSK’s oncology research will focus on innovations in immuno-oncology, cell therapy, cancer epigenetics, and, more recently, genetic medicine.

GlaxoSmithKline plc (GSK; LSE: GSK, NYSE: GSK) is the world’s third-largest pharmaceutical, biotechnology, and healthcare company by revenue, trailing only Johnson & Johnson and Pfizer, with its headquarters in London, United Kingdom. Its business spans anti-infectives, central nervous system disorders, respiratory diseases, gastrointestinal/metabolic conditions, oncology, and vaccines, while also encompassing leading oral healthcare products, nutritional beverages, and certain over-the-counter medications.

Merck Group, founded in 1668 with a history of approximately 350 years, is headquartered in Darmstadt, Germany. The group is primarily dedicated to innovative pharmaceuticals, life sciences, and advanced performance materials technologies. Driven by technology, Merck Group consistently creates value for patients and customers.

(Compiled by Ning Chen)