On June 29, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported the initiation of the Phase 2 clinical study designed to evaluate the tolerability, safety and efficacy of CRS-207, Aduro’s lead listeria-based immunotherapy construct (LADD), in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada), for the treatment of patients with gastroesophageal adenocarcinoma who have failed two prior chemotherapy treatments (Press release, Aduro Biotech, JUN 29, 2017, View Source [SID1234519730]).

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Clinical trial sites have been activated and the study is open for enrollment. "Gastroesophageal adenocarcinoma is an aggressive, difficult to treat cancer for which there is currently no FDA-approved therapy for those in need of a third-line treatment option," stated Natalie Sacks, M.D., chief medical officer of Aduro Biotech. "We are pleased to be evaluating the CRS-207/KEYTRUDA combination in this Phase 2 clinical trial for late-stage gastroesophageal cancer patients and hope to see similar synergistic anti-cancer activity as observed in preclinical studies with this investigational treatment regimen." The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with KEYTRUDA in adults with gastric, gastroesophageal junction, or esophageal adenocarcinoma who have received two prior systemic chemotherapy treatment regimens for advanced disease. The trial will be conducted at up to 15 sites and will enroll approximately 70 patients. The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses. For additional information about the study, please visit www.clinicaltrials.gov (search identifier NCT03122548). About Gastroesophageal Adenocarcinoma Gastroesophageal adenocarcinoma is an aggressive form of cancer effecting the esophagus and/or stomach. In 2015, the National Cancer Institute estimated 16,980 new diagnoses of esophageal cancer and 24,590 new diagnoses of gastric cancer will occur in the United States, with an overall five-year survival rate of 20 percent and 30 percent, respectively. Approximately 50 percent of patients present with unresectable or locally advanced disease at the time of diagnosis. Up to approximately 50 percent of these cancer tumor types are known to express mesothelin, a tumor-associated antigen with limited expression on the surface of normal tissues. Currently, there is no U.S. Food and Drug Administration-approved therapy for the third-line treatment of gastroesophageal adenocarcinoma. About LADD and CRS-207 LADD is Aduro’s proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate an innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. CRS-207, the company’s lead LADD product candidate, has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including gastric cancer and esophageal adenocarcinoma, as well as mesothelioma, pancreatic, non-small cell lung, ovarian and endometrial cancers.