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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

WILMINGTON, Del.--(BUSINESS WIRE)--Feb. 5, 2014-- 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.

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Source: Incyte Corporation

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944

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