March 24, 2016 10:23am
In a combination clinical trial of CRS-207 and Epacadostat to treat ovarian cancer
ADRO’s first patient has been dosed in SEASCAPE, the P1/2 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 (INCY) selective IDO1 inhibitor, in patients with ovarian cancer.
The Bottom Line: By combining two immuno-oncology therapies which ADRO believes have synergistic mechanisms of action, ADRO 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. Combination therapy is rapidly emerging as a new paradigm for immuno-oncology
- … still early, the read out will define the expectation of continuation;
- 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.
ADRO closed at $12.47 and is DOWN -$0.11 or -0.88%, traders are selling into past strength pre a short trading week
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 P1 followed by expansion into P2 which will evaluate the combination at the recommended (or identified) dose level compared to CRS-207 alone.
- ADRO plans to enroll up to 40 patients in P1 and up to 86 patients in P2 with platinum-resistant ovarian, fallopian or peritoneal cancers.
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 P3 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.