TIDMGSK
RNS Number : 1388P
GlaxoSmithKline PLC
05 February 2019
Issued: 05 February 2019, London UK - LSE Announcement
GSK and Merck KGaA, Darmstadt, Germany announce global alliance
to jointly develop and commercialise M7824, a novel immunotherapy
with potential in multiple difficult-to-treat cancers
-- 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 KGaA, Darmstadt, Germany will receive an upfront
payment of EUR300 million (GBP260 million) and is eligible for
potential development milestone payments of up to EUR500 million
(GBP440 million) triggered by data from the M7824 lung cancer
programme, plus future approval and commercial milestones of up to
EUR2.9 billion (GBP2.5 billion), for a total potential deal value
of up to EUR3.7 billion (GBP3.2 billion)
GlaxoSmithKline plc (LSE/NYSE: GSK) and Merck KGaA, Darmstadt,
Germany today announced that they have entered into a global
strategic alliance to jointly develop and commercialise 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).
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.
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "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. I'm excited by the
potential impact this first-in-class immunotherapy could have on
the lives of cancer patients."
Dr Belén Garijo, Member of the Executive Board and CEO
Healthcare of Merck KGaA, Darmstadt, Germany said: "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. 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."
Merck KGaA, Darmstadt, Germany will receive an upfront payment
of EUR300 million (GBP260 million) and is eligible for potential
development milestone payments of up to EUR500 million (GBP440
million) triggered by data from the M7824 lung cancer programme.
Merck KGaA, Darmstadt, Germany will also be eligible for further
payments upon successfully achieving future approval and commercial
milestones of up to EUR2.9 billion (GBP2.5 billion). The total
potential deal value is up to EUR3.7 billion (GBP3.2 billion). Both
companies will jointly conduct development and commercialisation
with all profits and costs from the collaboration being shared
equally on a global basis.
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.
This alliance reflects Merck KGaA, Darmstadt, Germany'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.
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-localised blocking of the two immuno-suppressive pathways -
targeting both pathways aims to control tumour growth by
potentially restoring and enhancing anti-tumour responses. M7824 is
currently in Phase I studies for solid tumours, as well as a
randomised Phase II trial to investigate M7824 compared with
pembrolizumab as a first-line treatment in patients with PD-L1
expressing advanced NSCLC. The multicentre, randomised, 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 tumour types in Phase I studies. Encouraging data from
the ongoing Phase I studies indicates M7824's potential safety and
clinical anti-tumour activity across multiple types of
difficult-to-treat cancers, including advanced NSCLC, human
papillomavirus-associated cancers, biliary tract cancer (BTC) and
gastric cancer. In addition, in pre-clinical studies M7824
demonstrated superior anti-tumour 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.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology
company, operates across healthcare, life science and performance
materials. Around 51,000 employees work to make a positive
difference to millions of people's lives every day by creating more
joyful and sustainable ways to live. From advancing gene editing
technologies and discovering unique ways to treat the most
challenging diseases to enabling the intelligence of devices - the
company is everywhere. In 2017, Merck KGaA, Darmstadt, Germany,
generated sales of EUR15.3 billion in 66 countries.
The company holds the global rights to the name and trademark
"Merck" internationally. The only exceptions are the United States
and Canada, where the business sectors of Merck KGaA, Darmstadt,
Germany operate as EMD Serono in healthcare, MilliporeSigma in life
science, and EMD Performance Materials. Since its founding 1668,
scientific exploration and responsible entrepreneurship have been
key to the company's technological and scientific advances. To this
day, the founding family remains the majority owner of the publicly
listed company.
(1) . Lan Y, et al. Enhanced preclinical anti-tumour activity of
M7824, a bifunctional fusion protein simultaneously targeting PD-L1
and TGF-<BETA>. Science Translational Medicine. 2018 Jan;
10(424).
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
US Media enquiries: Sarah Spencer +1 215 751 3335 (Philadelphia)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Analyst/Investor Sarah Elton-Farr +44 (0) 208 047 (London)
enquiries: 5194
Danielle Smith +44 (0) 20 8047 (London)
7562
James Dodwell +44 (0) 20 8047 (London)
2406
Mel Foster-Hawes +44 (0) 20 8047 (London)
0674
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statements regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item
3.D Principal risks and uncertainties in the company's Annual
Report on Form 20-F for 2017.
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END
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