Immunocore Limited and Eli Lilly and Company (NYSE:LLY) today announced
that they have entered into an immunotherapy-based clinical trial
collaboration to explore the utility of Immunocore’s lead T-cell
receptor based investigational therapeutic, IMCgp100, in combination
with Lilly’s galunisertib (LY2157299) and merestinib (LY2801653) for the
treatment of melanoma. The goal of the collaboration is to identify
combination regimens that provide synergies in efficacy and durability
in patients with metastatic cutaneous and uveal melanomas.
Under the terms of the agreement, Immunocore and Lilly will conduct a
Phase Ib/II clinical study evaluating the safety and preliminary
efficacy of IMCgp100 in combination with galunisertib in metastatic
cutaneous melanoma. A second Phase Ib/II study will be conducted
combining IMCgp100 with merestinib in metastatic uveal melanoma. Lilly
will act as trial sponsor. These studies are anticipated to begin in
2016. No financial terms were disclosed.
IMCgp100 and galunisertib are members of a new class of cancer
treatments known as immunotherapies, which are designed to enhance the
body’s own immune system in fighting cancer and whose mechanisms of
action have the potential to be complementary. IMCgp100 is Immunocore’s
most advanced Immune mobilising mTCR Against Cancer molecules (ImmTAC),
which are a novel class of bi-specific biologic drugs based on T-cell
receptors (TCRs) with ultra-high affinity for intracellular and
extracellular cancer targets. Lilly’s galunisertib is a small molecule
inhibitor of TGF beta R1 kinase that in vitro selectively blocks TGF
beta signaling. TGF beta promotes tumor growth, suppresses the immune
system and increases the ability of tumors to spread in the body.
Merestinib is Lilly’s small molecule multi-kinase inhibitor that in
vitro selectively blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2.
“This collaboration with Immunocore underscores Lilly’s commitment to
discovering the potential of combination therapies, which will be key to
the future of cancer care for people fighting diseases such as
melanoma,” said Richard Gaynor, M.D., senior vice president, product
development and medical affairs for Lilly Oncology. “Lilly is building a
robust portfolio of potential advances in immunotherapy through our own
research as well as with strategic collaborations like Immunocore.”
Immunocore and Lilly entered into a co-discovery and co-development
collaboration, announced in July 2014, to research and potentially
develop other novel T-cell-based cancer therapies built on Immunocore’s
“We are very pleased to be able to announce a second collaboration with
Lilly after entering into a collaboration last year,” said Eliot
Forster, Chief Executive Officer of Immunocore. “Combining our
ImmTAC, IMCgp100 with Lilly’s galunisertib and merestinib has the
potential to transform the treatment of metastatic cutaneous and uveal
melanoma. Immunocore is committed to the development of IMCgp100 in
metastatic uveal and cutaneous melanoma where there is such great unmet
Notes for editors
Melanoma is a cancer that begins in the melanocytes. Other names for
this cancer include malignant melanoma and cutaneous
melanoma. Most melanoma cells still make melanin, so melanoma tumors
are usually brown or black. But some melanomas do not make melanin and
can appear pink, tan, or even white.
Melanomas can develop anywhere on the skin, but they are more likely to
start on the trunk (chest and back) in men and on the legs in women. The
neck and face are other common sites.
Melanoma is much less common than basal cell and squamous cell skin
cancers, but it is far more dangerous. Like basal cell and squamous cell
cancers, melanoma is almost always curable in its early stages. But it
is much more likely than basal or squamous cell cancer to spread to
other parts of the body if not caught early. i
According to the American Cancer Society’s estimates for melanoma in the
United States for 2015, about 73,870 new melanomas will be diagnosed
(about 42,670 in men and 31,200 in women); and about 9,940 people are
expected to die of melanoma (about 6,640 men and 3,300 women).
Uveal (or ocular) melanoma is a cancer of the eye diagnosed in
approximately 2,000-2,500 adults annually in the United States. In both
the U.S. and Europe, this equates to about 5 – 7.5 cases per million
people per year and, for people over 50 years old, the incidence rate
increases to around 21 per million per year. iii
About IMCgp100 and ImmTACs
Immunocore’s proprietary technology is focused on small protein
molecules called ImmTACs (Immune mobilising mTCR Against Cancer) that
enable the immune system to recognise and kill cancerous cells.
Immunocore’s ImmTACs, a new class of drug with ultra-high affinity for
intracellular cancer targets, are synthetic, soluble T cell receptors
(TCRs) that recognise diseased cells containing disease specific
targets. The ImmTACs enable circulating T-cells to selectively identify
and kill diseased cells. The ImmTAC platform is unique and has very high
specificity and potency as well as broad applicability to a wide range
of intracellular targets. ImmTACs can access up to nine-fold more
targets than typical antibody-based therapies, including monoclonal
TCRs naturally recognise diseased cells and Immunocore’s world-leading
competitive advantage is its ability to engineer high affinity TCRs and
link them to an antibody fragment that activates a highly potent and
specific T cell response to recognise and destroy cancer cells.
Immunocore recently announced clinical efficacy data in a Phase I/IIa
trial with IMCgp100 in patients with advanced melanoma, as well as in
the expansion cohort with uveal melanoma.
The most advanced ImmTAC, IMCgp100, is currently in Phase IIa clinical
trials for the treatment of late stage melanoma. Following completion of
a Phase I study at the end of 2013, Immunocore initiated a Phase IIa
study to optimize the dosing regimen of IMCgp100. Immunocore has a
growing internal pipeline of ImmTACs addressing many different cancer
types and has developed a broad database of intracellular cancer targets.
About Galunisertib (LY2157299)
Galunisertib is a TGF beta R1 kinase inhibitor that in vitro selectively
blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses
the immune system and increases the ability of tumors to spread in the
About Merestinib (LY2801653)
Merestinib is Lilly’s multi-kinase inhibitor that in vitro selectively
blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2.
Immunocore is one of the world’s leading biotechnology companies, with a
highly innovative immuno-oncology platform technology called ImmTACs.
ImmTACs are a novel class of biologic drugs based on the Company’s
proprietary T cell receptor (TCR) technology which have the potential to
treat diseases with high unmet medical need including cancer, viral
infections and autoimmune diseases. Immunocore has a pipeline of
wholly-owned and partnered ImmTAC programmes with robust clinical data,
based on decades of world-leading scientific innovation in the discovery
of HLA targets and T cell receptor technology and validated by
collaborations with world-leading pharmaceutical companies. Immunocore
aims to leverage the utility of its platform across a wide range of
indications to become a Premier Biotech company and world-leader in its
Immunocore’s world-leading science and strong IP position has attracted
major pharmaceutical companies including Genentech, GlaxoSmithKline,
MedImmune, the biologics division of AstraZeneca, via discovery
collaborations, as well as a co-discovery and co-development partnership
with Lilly. Founded in 2008 originally out of Oxford University and
headquartered outside Oxford, Immunocore now has more than 150 staff.
Immunocore is well funded and owned by a group of long-term private
investors. For more information, please visit www.immunocore.com
About Lilly Oncology
For more than fifty years, Lilly has been dedicated to delivering
life-changing medicines and support to people living with cancer and
those who care for them. Lilly is determined to build on this heritage
and continue making life better for all those affected by cancer around
the world. To learn more about Lilly’s commitment to people with cancer,
please visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to
make life better for people around the world. We were founded more than
a century ago by a man committed to creating high-quality medicines that
meet real needs, and today we remain true to that mission in all our
work. Across the globe, Lilly employees work to discover and bring
life-changing medicines to those who need them, improve the
understanding and management of disease, and give back to communities
through philanthropy and volunteerism. To learn more about Lilly, please
visit us at www.lilly.co.uk.
Lilly Forward-Looking Statement
This press release contains “forward-looking statements” (as that
is defined in the United States Private Securities Litigation Reform Act
of 1995) regarding the research collaboration between Immunocore and
Lilly. This press release reflects Lilly’s current beliefs.
However, there are substantial risks and uncertainties in the process of
drug research, development, and commercialization. Among other risks,
there can be no guarantee that these investigational combination
regimens will receive regulatory approval, or, if approved, that they
will achieve intended benefits or become commercially successful
products. For further discussion of these and other risks and
uncertainties that could cause actual results to differ materially from
Lilly’s expectations, please see the company’s latest Forms 10-K and
10-Q filed with the U.S. Securities and Exchange Commission. Except as
required by law, Lilly undertakes no duty to update forward-looking
[i] American Cancer Society. What is melanoma skin cancer?
Revised March 20, 2015.
(Accessed June 25, 2015).
[ii] American Cancer Society. What are the keys statistics
about melanoma skin cancer? Revised March 20, 2015.
(Accessed June 25, 2015).
[iii] Ocular Melanoma Foundation. About Ocular
(Accessed June 19, 2015).
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