Merck and GSK Announce Global Alliance to Jointly Develop and Commercialize M7824, a Novel Immunotherapy with Potential in Multiple Difficult-to-Treat Cancers

PR77349

DARMSTADT, Germany, Feb. 5, 2019 /PRNewswire=KYODO JBN/ --

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    - Eight high priority immuno-oncology clinical development studies ongoing

or expected to commence in 2019, including studies in non-small cell lung and

biliary tract cancers

     - Merck will receive an upfront payment of EUR300 million and is eligible

for potential development milestone payments of up to EUR500 million triggered

by data from the M7824 lung cancer program, plus future approval and commercial

milestones of up to EUR2.9 billion for a total potential deal value of up to EUR3.7 billion

    Merck, a leading science and technology company, and GSK, a science-led

global healthcare company, today announced that the companies have entered into

a global strategic alliance to jointly develop and commercialize M7824

(bintrafusp alfa*). M7824 is an investigational bifunctional fusion protein

immunotherapy that is currently in clinical development, including potential

registration studies, for multiple difficult-to-treat cancers. This includes 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).

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    M7824 is designed to simultaneously target two immuno-suppressive pathways,

transforming growth factor-beta (TGF-beta) 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.[1] 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.

    "Our 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," said Belen Garijo, Member of the Executive Board and CEO

Healthcare of Merck. "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."

    Merck will receive an upfront payment of EUR300 million and is eligible for

potential development milestone payments of up to EUR500 million triggered by

data from the M7824 lung cancer program. Merck will also be eligible for

further payments upon successfully achieving future approval and commercial

milestones of up to EUR2.9 billion. The total potential deal value is up to

EUR3.7 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 have the leadership position in this new

class of immunotherapies, specifically leveraging TGF-beta biology.

    *Bintrafusp alfa is the proposed International Nonproprietary Name (INN)

for the bifunctional immunotherapy M7824. Bintrafusp alfa is currently under

clinical investigation and not approved for any use anywhere in the world.

    About M7824 (also now known as bintrafusp alfa)

    M7824 is an investigational bifunctional immunotherapy that is designed to

combine a TGF-beta trap with the anti-PD-L1 mechanism in one fusion protein.

M7824 is designed to combine co-localized blocking of the two

immuno-suppressive pathways - targeting both pathways aims to control tumor

growth by potentially restoring and enhancing anti-tumor responses. M7824 is

currently in Phase I studies for solid tumors, as well as a randomized Phase II

trial to investigate M7824 compared with pembrolizumab as a first-line

treatment in patients with PD-L1 expressing advanced NSCLC. The multicenter,

randomized, open-label, controlled study is evaluating the safety and efficacy

of M7824 versus pembrolizumab as a monotherapy treatment.

    To-date, nearly 700 patients have been treated with M7824 across more than

10 tumor types in Phase I studies. Encouraging data from the ongoing Phase I

studies indicates M7824's potential safety and clinical anti-tumor activity

across multiple types of difficult-to-treat cancers, including advanced NSCLC,

human papillomavirus-associated cancers, biliary tract carcinoma (BTC) and

gastric cancer. In addition, in pre-clinical studies M7824 demonstrated

superior anti-tumor activity, compared with anti-PD-L1 alone or with anti-PD-L1

and TGF-beta trap when co-administered. In total, eight high priority

immuno-oncology clinical development studies are ongoing or expected to

commence in 2019, including studies in non-small cell lung and biliary tract

cancers.

    References

    1) Lan Y, et al. Enhanced preclinical antitumor activity of M7824, a

bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta.

Science Translational Medicine. 2018 Jan; 10(424).

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