Clinical Trials

Date: 2016-03-24

Type of information: Treatment of the first patient

phase: 1-2

Announcement: treatment of the first patient

Company: Aduro Biotech (USA - CA) Incyte (USA - DE)

Product: epacadostat and CRS-207

Action mechanism:

enzyme inhibitor/immunotherapy product. 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 types.
CRS-207 is one of a family of product candidates based on Aduro's live-attenuated, double-deleted (LADD)Listeria monocytogenes immuno-oncology platform that are designed to induce potent innate and adaptive immune responses. 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 and gastric cancers.

Disease: platinum-resistant ovarian cancer, platinum-resistant fallopian cancer, platinum-resistant peritoneal cancer,

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

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. (NCT02575807 )

Latest news:

• On March 24, 2016, Aduro Biotech announced 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 selective IDO1 inhibitor, in patients with ovarian cancer. SEASCAPE (Study of Epacadostat and CRS-207 in Adults with Platinum Resistant Ovarian Cancer) is co-funded by Incyte and Aduro, Incyte and Aduro 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.