INDIANAPOLIS and OXFORD, England, June
29, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) and Immunocore Limited 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 mobilizing 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,
pathways that potentially play a role in metastatic uveal
melanoma.
"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
ImmTAC platform.
"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 medical need."
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.
About Melanoma
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).[ii]
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 mobilizing mTCR Against Cancer)
that enable the immune system to recognize 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 recognize 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 antibodies.
TCRs naturally recognize 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 recognize and
destroy cancer cells.
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 body.
About Merestinib (LY2801653)
Merestinib is Lilly's multi-kinase inhibitor that in vitro
selectively blocks signaling of MET, MST1R (RON), AXL, and
MKNK1/2.
About Immunocore
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 programs 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 field.
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.com and
newsroom.lilly.com/social-channels. P-LLY
Lilly Forward-Looking Statement
This press release contains "forward-looking statements" (as
that term 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 statements.
[i] American Cancer Society. What is melanoma skin cancer?
Revised March 20, 2015.
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-what-is-melanoma
(Accessed June 25, 2015).
[ii] American Cancer Society. What are the keys statistics about
melanoma skin cancer? Revised March 20,
2015.
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics
(Accessed June 25, 2015).
[iii] Ocular Melanoma Foundation. About Ocular Melanoma.
http://www.ocularmelanoma.org/about-om.htm (Accessed June 19, 2015).
Refer
to:
|
Karen Glowacki;
kglowacki@lilly.com; (317) 370-1177
(Lilly)
|
|
Neil Hochman;
n.hochman@togorun.com; (212) 453-2067 (TogoRun)
|
|
Eliot Forster;
info@immunocore.com; +44 (0)1235 438600 (Immunocore)
|
|
Mary-Jane Elliott;
Immunocore@consilium-comms.com; +44 (0)203 709 5700
(Consilium)
|
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