On January 11, 2016 Incyte Corporation (Nasdaq: INCY) reported significant and rapid progress in its continued transformation into a leading global biopharmaceutical company (Press release, Incyte, JAN 11, 2016, View Source [SID:1234508719]). With two new programs expected to enter the clinic in the coming months, Incyte will have 13 development molecules in pivotal and proof-of-concept trials across a variety of oncology and non-oncology indications, illustrating the power of Incyte’s drug discovery and development engine.

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"We are experiencing a revolution in the way cancer is treated, and Incyte is at the forefront of innovation in drug discovery," said Hervé Hoppenot, President and Chief Executive Officer, Incyte. "Our rich portfolio of small molecules and biologics places us in a unique position. We have significant optionality to investigate these candidates alone as well as in combination as we continue our mission to deliver medicines that will positively impact the lives of patients with cancer and other diseases."

Presentation Highlights

JAK Inhibitors
The Phase 3 JANUS 1 trial of ruxolitinib, a JAK1 / JAK2 inhibitor, in second line metastatic pancreatic cancer is now fully recruited, with results expected in 2016. The primary endpoint of JANUS 1 is overall survival. Two Phase 2 trials of ruxolitinib, in colorectal and breast cancer, are now fully recruited, with overall survival data expected from both in 2016.

Incyte has two selective JAK1 inhibitors in clinical development, INCB39110 and INCB52793. A clinical collaboration has been initiated to investigate the safety and efficacy of the combination of INCB39110 with AstraZeneca’s next generation EGFR inhibitor Tagrisso (osimertinib)* in patients with EGFRm non-small cell lung cancer with the T790M mutation. Incyte’s second JAK1 selective inhibitor, INCB52793, is in a dose escalation study in patients with advanced malignancies. INCB52793 has shown synergistic efficacy in combination with standard of care in preclinical models of multiple myeloma.

Building upon positive, published third-party data of ruxolitinib from an investigator-sponsored trial in graft versus host disease (GVHD), a proof-of-concept trial of INCB39110 for the treatment of patients with GVHD has begun.

Each of the four pivotal trials of baricitinib, a JAK1 / JAK2 inhibitor licensed by Incyte to Eli Lilly and Company, met the primary endpoint in patients with rheumatoid arthritis. Lilly is finalizing the submissions of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency. Both will trigger milestone payments from Lilly to Incyte.

IDO1 Inhibitor
The ECHO (Epacadostat Clinical development in Hematology and Oncology) program has been designed to investigate combinations of Incyte’s IDO1 inhibitor, epacadostat, across the full cycle of anti-tumor immunity, including with checkpoint blockade, vaccines and other modulators of the tumor immune response.

The Phase 3 ECHO-301 study evaluating the combination of epacadostat with the anti-PD-1 antibody Keytruda (pembrolizumab)* for the first-line treatment of patients with advanced or metastatic melanoma is expected to begin in the first half of 2016. Recruitment has also begun into the eight tumor-specific cohorts of ECHO-202, the Phase 2 trial of epacadostat in combination with pembrolizumab.

Incyte is conducting three additional Phase 1/2 clinical trials of epacadostat in combination with immune checkpoint inhibitors. ECHO-204, in combination with Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab)*, has opened seven tumor specific cohorts, and ECHO-203 with AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, durvalumab, has opened six tumor specific cohorts. ECHO-110, a trial in combination with Roche/Genentech’s investigational PD-L1 inhibitor, atezolizumab, in patients with NSCLC is ongoing.

Selected Portfolio Updates
Incyte’s PI3Kδ inhibitor clinical development program is focused on INCB50465, based on the molecule’s potential lack of hepatotoxicity and improved potency compared to approved PI3Kδ inhibitors and compared to Incyte’s PI3Kδ inhibitor INCB40093. A Phase 1/2 trial of INCB50465, both as monotherapy and in combination with INCB39110, is already underway in multiple B-cell malignancies. Clinical activities of INCB40093 are being closed.

Incyte is also pursuing a series of clinical studies to investigate the safety and efficacy of several therapeutic doublets. These include a clinical trial of Incyte’s JAK1 inhibitor, INCB39110, in combination with either its IDO1 inhibitor, epacadostat, or its PI3Kδ inhibitor, INCB50465, as well as a trial of Merck’s anti-PD-1 antibody, pembrolizumab, in combination with either Incyte’s PI3Kδ inhibitor, INCB50465, or its JAK1 inhibitor, INCB39110.

Two new compounds are expected to enter Incyte’s clinical development portfolio in the first half of 2016. INCB59872, a potent and selective LSD1 inhibitor, is expected to enter clinical trials in patients with advanced malignancies in the coming months. INCAGN1876, an anti-GITR agonist antibody that is part of the ongoing discovery alliance with Agenus, Inc, is expected to enter clinical trials for the treatment of patients with advanced cancer during the first half of 2016. Incyte’s alliance with Agenus has recently been expanded to include a total of 7 therapeutic targets, with options for additional expansion.

Corporate Update
In January 2016, Michael Morrisey joined Incyte Europe Sàrl and the Incyte Executive Management team as Corporate Senior Vice President and Head of Global Technical Operations. Michael has extensive manufacturing experience and has excelled in building manufacturing organizations, most recently as Corporate Vice President, Head of International Technical Operations at Celgene International.

Webcast Information
A presentation made by Incyte at the 34th Annual J.P. Morgan Healthcare Conference will be webcast live today at 1:30pm PT / 4:30pm ET and can be accessed within the Investors section of www.incyte.com under Events and Presentations. Investors interested in listening to the live webcast should log on before the start time in order to download any software required. The slide deck and a replay of the presentation will also be made available following the presentation.