|View printer-friendly version|
|Incyte Announces Clinical Trial Collaboration with Merck to Evaluate Combination of Two Novel Immunotherapies|
Phase I/II study to evaluate the safety and efficacy of Incyte’s investigational oral IDO1 inhibitor with Merck’s investigational anti-PD-1 immunotherapy for 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
“We are pleased to be collaborating with
Under the terms of the agreement,
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).
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/.
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
Links to third party websites or pages are provided for convenience