Aduro Biotech and Merck expanded their clinical collaboration to include a second clinical study combining Aduro’s live, attenuated double-deleted (LADD) Listeria-based immunotherapy CRS-207 with Merck’s anti-PD-1 drug Keytruda® (pembrolizumab). The open-label Phase II efficacy and safety study is expected to include approximately 35 patients with malignant pleural mesothelioma (MPM) whose disease has progressed following one or two prior treatments.
In January Merck and Aduro signed a clinical collaboration agreement to carry out a Phase I study combining CRS-207 with Keytruda for treating gastric cancer.
An ongoing Phase I study evaluating CRS-207 combined with standard chemotherapy as frontline treatment for MPM is yielding promising data, including disease control in 94% of treated patients, according to Natalie Sacks, M.D., chief medical officer at Aduro. “Based on these clinical data, as well as data from preclinical studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase II trial to evaluate the CRS-207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment.”
Aduro is developing a pipeline of cancer immunotherapies based on its LADD, STING Pathway Activator, and B-select monoclonal antibody platforms. The LADD technology is based on strains of Listeria that are engineered to express tumor-associated antigens that induce specific, targeted immune responses. The firm is developing LADD therapies for potential indications including ovarian, lung and prostate cancers, mesothelioma and glioblastoma.
Lead LADD candidate CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which the firm says is overexpressed in cancers including mesothelioma, pancreatic, non-small cell lung, ovarian, endometrial and gastric. Aduro partnered with Incyte in September 2015 to carry out a 50/50 funded Phase I/II clinical trial evaluating CRS-207 in combination with the latter’s oral indoleamine dioxygenase 1 (IDO1) inhibitor, epacadostat, in patients with ovarian cancer.