European drug multinationals Merck KgaA and GSK Plc have jointly announced that they have entered into a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa), a novel immmuno therapy drug with potential to treat multiple difficult-to-treat cancers.
This investigational bifunctional fusion protein immunotherapy, is currently in clinical development, including potential registration studies. A Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced non-small cell lung cancer (NSCLC) is also currently going on as part of the clinical development. Bintrafusp alfa is the proposed International Nonproprietary Name (INN) for the bifunctional immunotherapy M7824 and it is not approved for any use anywhere in the world.
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. M7824 has the potential to offer new ways to fight 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.
In the clinical development, eight high priority immuno-oncology clinical development studies ongoing or expected to commence in 2019. This include studies in non-small cell lung and biliary tract cancers as well.
According to Belén Garijo, member of the Executive Board and CEO, Healthcare business of Merck, Merck’s 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,” added Garijo.
“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. We now look forward to harnessing the full potential of M7824 across a broad range of cancer indications as we continue to advance our oncology portfolio.”
“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 R&D, GSK. “I’m excited by the potential impact this first-in-class immunotherapy could have on the lives of cancer patients.”
As part of the joint development and commercialisation agreement, Merck will receive an upfront payment of €300 million and is eligible for potential development milestone payments of up to €500 million triggered by data from the M7824 lung cancer program, plus future approval and commercial milestones of up to €2.9 billion for a total potential deal value of up to €3.7 billion. Both companies will jointly conduct development and commercialization with all profits and costs from the collaboration being shared equally on a global basis.
This alliance reflects Merck’s strategic approach to oncology R&D, identifying those opportunities that can progress the company’s highly promising clinical stage assets as efficiently and rapidly as possible, whether through internal expertise and capabilities or external collaborations.
For GSK, this alliance is a further step in the company’s priority to strengthen its pharmaceuticals pipeline. This follows the company’s recent acquisition of TESARO, an oncology-focused company based in Waltham, Massachusetts. GSK’s approach to oncology is focused on innovation in the areas of immuno-oncology, cell therapy, cancer epigenetics and, most recently, genetic medicine.
With this alliance, both companies will have the leadership position in this new class of immunotherapies, specifically leveraging TGF-β biology, the companies said a joint media statement on Tuesday.