BERKELEY, Calif.--(Business Wire)--Aduro Biotech, Inc. today announced that seven pancreatic cancer patients treated with its combination immuno-oncology regimen in a 93-patient Phase 2a clinical trial continue in survival follow-up, with two of those patients remaining on the company's combination therapy for more than two years with no evidence of cumulative toxicity. Furthermore, the company reported data from ongoing immune monitoring analyses of the trial that show a statistically significant correlation in the breadth and quantity of patients' antigen-specific CD8 T cell responses to treatment with overall survival. The analyses also identified a subset of cytokines that, when measured prior to treatment, correlated with longer overall survival. The data were presented at the American Society of Clinical Oncology (ASCO) 2015 Gastrointestinal Cancers Symposium in San Francisco.
"We are very encouraged and delighted to see long-term survivors in our Phase 2a clinical trial in patients with advanced pancreatic cancer, an aggressive disease with particularly high mortality rates," said Dirk Brockstedt, Ph.D., senior vice president, Research and Development at Aduro. "In addition, comprehensive immune and biomarker testing has provided useful insight into some of the characteristics of patients with more durable responses, including certain immune system characteristics that may potentially provide predicative value on how and when patients will respond to our immunotherapy."
Preliminary results of patient blood cells and serum measured at baseline and following treatment revealed candidate biomarkers associated with overall response to treatment. Baseline peripheral blood phenotype and functional status of the patients' immune systems, as measured by expression levels of predictive cellular and protein biomarkers using mass cytometry (CyTOF) and Luminex, were found to be significantly associated with overall survival. Moreover, enhanced tumor mesothelin-specific T cell responses after treatment, as evaluated by ELISpot, were associated with longer overall survival.
In this randomized controlled Phase 2a clinical trial, the combination of CRS-207 with GVAX Pancreas demonstrated a statistically significant improvement in overall survival compared to GVAX Pancreas alone in patients with metastatic pancreatic cancer who previously received or refused prior chemotherapy.
Results from the study were recently reported in the Journal of Clinical Oncology. Our lead immuno-oncology regimen of CRS-207 and GVAX Pancreas was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration based on the data from this study.
Aduro is currently conducting a 240 patient Phase 2b clinical trial, ECLIPSE, in patients with metastatic pancreatic cancer who received at least one prior chemotherapy treatment in a metastatic setting. The randomized, controlled three-arm trial will involve over 20 clinical trial sites in the United States and Canada and will evaluate the safety, immune response and efficacy of Aduro's immuno-oncology regimen of CRS-207 and GVAX Pancreas, compared to both single-agent chemotherapy and CRS-207 monotherapy. The primary endpoint of the trial is overall survival. More information about ECLIPSE can be found at www.clinicaltrials.gov identifier NCT02004262.
LADD is Aduro's proprietary platform of live, attenuated, double-deleted Listeria monocytogenes strains that have been engineered to initiate a powerful innate immune response and drive a targeted, durable adaptive immune response.
CRS-207 is Aduro's lead LADD product candidate, engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, lung, ovarian and gastric cancers.
About GVAX Pancreas
GVAX Pancreas is one of a family of GVAX vaccines derived from human cancer cell lines and is designed to activate specific T cell immunity to cancer antigens including mesothelin, enabling a broad-based immune response.
About Aduro Biotech
Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company focused on the development of its live, attenuated, double-deleted (LADD) Listeria monocytogenes and cyclic dinucleotide (CDN) technology platforms to initiate powerful innate immune responses and drive targeted, durable adaptive immune responses against cancer. Aduro has received Breakthrough Therapy designation from the FDA for its lead immuno-oncology regimen, CRS-207 and GVAX Pancreas, in pancreatic cancer. The company is evaluating CRS-207 and GVAX Pancreas in the ongoing Phase 2b ECLIPSE clinical trial and has additional ongoing clinical trials with its LADD product candidates in mesothelioma and glioblastoma. The company is also developing clinical candidates using synthetic small molecule CDNs that are designed to activate the intracellular STING receptor. For more information, please visit www.aduro.com.
Aduro Biotech, Inc.
Greg W. Schafer, 510-809-4801
Chief Operating Officer
Angela Bitting, 925-202-6211
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