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

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Darmstadt, Germany (ots/PRNewswire) -

- 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-? (TGF-?) 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 Belén 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-?
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-? 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-? 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-?. Science Translational Medicine. 2018 Jan; 10(424).

GSK - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human
life by enabling people to do more, feel better and live longer. For
further information please visit www.gsk.com.

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healthcare, life science and performance materials. Around 51,000
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From advancing gene editing technologies and discovering unique ways
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Scientific exploration and responsible entrepreneurship have been
key to Merck's technological and scientific advances. This is how
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holds the global rights to the Merck name and brand. The only
exceptions are the United States and Canada, where the business
sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma
in life science, and EMD Performance Materials.

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