On March 24, 2016 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that the first patient has been dosed in SEASCAPE, the Phase 1/2 clinical study designed to evaluate the safety, tolerability and preliminary efficacy of CRS-207, Aduro’s lead listeria-based immunotherapy construct (LADD), in combination with epacadostat (INCB24360), Incyte Corporation’s (Nasdaq:INCY) selective IDO1 inhibitor, in patients with ovarian cancer (Press release, Aduro BioTech, MAR 24, 2016, View Source [SID:1234509924]). Schedule your 30 min Free 1stOncology Demo! "By combining two immuno-oncology therapies which we believe have synergistic mechanisms of action, we and Incyte look forward to potentially advancing new treatment options for patients with ovarian cancer that could result in more effective therapy than either therapy alone," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Combination therapy is rapidly emerging as a new paradigm for immuno-oncology. With our three diverse technology platforms – LADD (listeria-based therapy), STING pathway activators and monoclonal antibodies – we intend to continue to identify new opportunities to improve patient care."
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SEASCAPE (Study of Epacadostat and CRS-207 in Adults with Platinum Resistant Ovarian Cancer), co-funded by Incyte and Aduro, is designed to establish a recommended dose based on safety and tumor biomarkers for CRS-207 and epacadostat in Phase 1 followed by expansion into Phase 2 which will evaluate the combination at the recommended (or identified) dose level compared to CRS-207 alone. Aduro plans to enroll up to 40 patients in Phase 1 and up to 86 patients in Phase 2 with platinum-resistant ovarian, fallopian or peritoneal cancers. For more information about the study, visit www.clinicaltrials.gov and search identifier NCT02575807.
Aduro and Incyte will collaborate on a non-exclusive basis. Aduro will be responsible for conducting the study and the results will be used to determine whether further clinical development of this combination is warranted. Costs for the trial will be shared on an equal basis.
About Epacadostat
Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity.
Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer histologies. A Phase 3 study evaluating the combination of epacadostat with pembrolizumab as first-line treatment for patients with advanced or metastatic melanoma is expected to begin in the first half of 2016.
About CRS-207
CRS-207 is one of a family of product candidates based on Aduro’s live, attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induces a potent innate and T cell-mediated adaptive immune response. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.