Incyte Corporation (Nasdaq: INCY) announced today that it has entered
into a clinical trial collaboration agreement with Merck, through a
Merck subsidiary, to evaluate the safety and efficacy of Incyte’s oral
indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, and Merck’s
investigational anti-PD-1 immunotherapy, MK-3475, in a Phase I/II study
in previously treated metastatic and recurrent non-small cell lung
cancer (NSCLC), and other advanced or metastatic cancers.
Both INCB24360 and MK-3475 are part of a new class of cancer treatments
known as immunotherapies that are designed to enhance the body’s own
defenses in fighting cancer. INCB24360 and MK-3475 target distinct
regulatory components of the immune system, and there is preclinical
evidence suggesting that the combination of these two agents may lead to
an enhanced anti-tumor immune response than either agent alone.
“The field of immunotherapy is evolving rapidly. Given the synergistic
activity we have seen with our IDO1 inhibitor when combined with
checkpoint inhibitors in preclinical models, we look forward to working
with Merck on this initial clinical collaboration,” stated Hervé
Hoppenot, President and Chief Executive Officer of Incyte. “To further
our understanding of the therapeutic value of our IDO1 inhibitor, we
intend to establish additional clinical collaborations with other
companies, cancer networks and academia.”
“We are pleased to be collaborating with Incyte to study MK-3475 as part
of this novel combination regimen,” said Dr. Eric Rubin, Vice President,
Clinical Development for Oncology, Merck Research Laboratories. “Early
evaluation of immunotherapeutic combinations is important in
accelerating the development of new options for patients with cancer."
Under the terms of the agreement, Incyte and Merck will collaborate on a
Phase I/II study to evaluate the safety and efficacy of the combination
in previously treated metastatic and recurrent NSCLC, and other advanced
or metastatic cancers. The Phase I portion of the trial is expected to
establish a recommended dose regimen of INCB24360 and MK-3475. In the
Phase II portion of the study, all patients receive MK-3475 and patients
will be randomized to receive either INCB24360 or matching placebo. The
study, which is expected to begin in the first half of 2014, will be
co-funded by Incyte and Merck and conducted by Incyte. Results from this
first study with Merck will be used to determine whether further
clinical development of this combination is warranted.
About INCB24360
INCB24360 is an orally bioavailable small molecule inhibitor of IDO1
that has nanomolar potency in both biochemical and cellular assays,
potent activity in enhancing T lymphocyte, dendritic cell and natural
killer cell responses in vitro, with a high degree of selectivity.
INCB24360 has been shown to be efficacious in mouse models of cancer as
a single agent and in combination with cytotoxic and immunotherapy
agents, and its ability to reduce tumor growth is dependent on a
functional immune system – consistent with its proposed mechanism of
action. A Phase I dose-escalation trial demonstrated that INCB24360
results in greater than 90 percent inhibition of IDO1 activity at
generally well-tolerated doses.
INCB24360 is currently in Phase I/II development for metastatic melanoma
in combination with ipilimumab (www.clinicaltrials.gov
Identifier: NCT01604889) and as monotherapy for ovarian cancer (www.clinicaltrials.gov
Identifier: NCT01685255).
About MK-3475
Many tumors are able to evade the immune system through a mechanism that
exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an
investigational, highly selective anti-PD-1 immunotherapy designed to
restore the natural ability of the immune system to recognize and target
cancer cells by selectively achieving dual ligand blockade (PD-L1 and
PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation
of the immune system’s T-cells that target cancer by essentially
releasing a brake on the immune system. For information on Merck’s
clinical trials please visit http://www.merck.com/clinical-trials/.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary small molecule drugs for oncology and inflammation. For
additional information on Incyte, please visit the Company's website at www.incyte.com.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation statements
with respect to the potential efficacy, safety and therapeutic value of,
and Incyte’s plans for, INCB24360, Incyte’s intent to establish
additional clinical collaborations with other companies, cancer networks
and academia, and the plans and expectations regarding the Phase I/II
study in the clinical trial collaboration with Merck, contain
predictions and estimates and are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of
INCB24360, the results of further research and development, risks that
results of clinical trials may be unsuccessful or insufficient to meet
applicable regulatory standards, the ability to enroll sufficient
numbers of subjects in clinical trials, other market or economic factors
and technological advances, unanticipated delays, the ability of Incyte
to compete against parties with greater financial or other resources,
and other risks detailed from time to time in Incyte's filings with the
Securities and Exchange Commission, including its Quarterly Report on
Form 10-Q for the quarter ended September 30, 2013. Incyte disclaims any
intent or obligation to update these forward-looking statements.
Links to third party websites or pages are provided for convenience
only. Each website is subject to its own terms of use, and Incyte
encourages you to consult these policy statements. Incyte has no control
over third party sites and does not endorse or recommend these sites,
and expressly disclaims any responsibility for the accuracy of content
or opinions set forth in any third party website or your use of that
information.
Copyright Business Wire 2014