On September 8, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has completed enrollment in the Phase 2b ECLIPSE trial of its novel LADD and GVAX immunotherapies being developed for the treatment of metastatic pancreatic cancer. The randomized, controlled three-arm trial enrolled 303 patients in the United States and Canada (Press release, Aduro BioTech, SEP 8, 2015, View Source;p=RssLanding&cat=news&id=2085917 [SID:1234507460]). Top line results are expected in the first half of 2016.

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ECLIPSE was designed to evaluate the safety, immune response and efficacy of the combination immunotherapy of CRS-207 and GVAX Pancreas compared to chemotherapy. The trial also included a treatment arm to evaluate CRS-207 as a monotherapy. The primary endpoint of the trial is overall survival in the primary cohort of patients who have received two or more prior therapies for metastatic disease. A second cohort of patients who received one prior therapy for metastatic disease is also being evaluated.

"This is a significant clinical trial in the pancreatic cancer field which has the potential to yield important information on the role of Aduro’s immunotherapy combination in this indication," said Vincent Picozzi, M.D., director of the Pancreatic Center of Excellence at the Virginia Mason Clinic. "Very few therapeutic options exist for metastatic pancreatic cancer patients, especially after initial chemotherapy, and this field could benefit greatly from more varied and attractive therapy options."

"The fight against metastatic pancreatic cancer continues to be arduous," said Dirk G. Brockstedt, Ph.D., senior vice president of research and development at Aduro. "We are encouraged by data from long-term survivors in our Phase 2a clinical trial and look forward to results from our Phase 2b ECLIPSE trial. We would like to thank our investigators, and more importantly the patients and their families, for their participation and support in our trials and development of our technologies in this indication."

The ECLIPSE trial was initiated following a Phase 2a trial which demonstrated efficacy of the immunotherapy combination with CRS-207 and GVAX Pancreas compared to GVAX Pancreas alone in a randomized, controlled, multi-center trial in metastatic pancreatic cancer patients. Results of the Phase 2a clinical trial, published in the Journal of Clinical Oncology (JCO), indicated the median overall survival of Arm A patients receiving the combination regimen of CRS-207 and GVAX Pancreas was 6.1 months compared to 3.9 months for Arm B patients receiving GVAX monotherapy (HR=0.5930, one-sided p=0.0172).

Overall, the combination immunotherapy was well-tolerated. Of the 93 patients enrolled, the most common Grade 3 adverse events were transient lymphopenia, fevers, elevated liver enzymes and fatigue.

In 2014, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Aduro’s pancreatic cancer combination treatment consisting of CRS-207 and GVAX Pancreas based on results from the Phase 2a clinical trial of patients with metastatic pancreatic cancer. According to the FDA, Breakthrough Therapy designation is for a drug candidate that treats a serious or life-threatening condition for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.

About CRS-207

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.

About GVAX Pancreas

GVAX Pancreas is one of a family of GVAX immunotherapies derived from human cancer cell lines that are genetically modified to express granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune system-stimulating cytokine. GVAX Pancreas is derived from human pancreatic cancer cell lines and is designed to activate specific T cell immunity to pancreatic cancer antigens, including mesothelin.