February 10, 2014 08:00 AM Eastern Standard Time
BERKELEY, Calif. -- Aduro BioTech, Inc. today announced the initiation of a Phase 2b clinical trial of the company’s immunotherapies GVAX Pancreas and CRS-207. The first patient has been treated in the randomized, controlled, multicenter trial.
“We are pleased to initiate this Phase 2b study so closely on the heels of our recent successful Phase 2 trial that demonstrated a significant impact in overall survival with our combination immunotherapy,” said Stephen T. Isaacs, chairman and chief executive officer of Aduro. “This new trial will build on our experience and provide additional insights into the safety and efficacy of our therapies.”
The ECLIPSE trial (Efficacy of Combination Listeria/GVAX Immunotherapy in the Pancreatic Cancer Setting) will enroll approximately 240 adults with previously-treated metastatic pancreatic cancer and will involve over 20 clinical trial sites in the U.S. and Canada. The randomized, controlled 3-arm trial will evaluate the safety, immune response and efficacy of the combination immunotherapy of GVAX Pancreas (with low-dose cyclophosphamide (CY)) and CRS-207 compared to chemotherapy or to CRS-207 alone. The primary endpoint of the trial is overall survival.
In the recently completed, randomized, controlled, multicenter Phase 2 trial in 93 patients in the same population, a statistically significant survival benefit was demonstrated in patients receiving the combination of CY/GVAX Pancreas and CRS-207 immunotherapies (Arm A) compared to patients receiving CY/GVAX Pancreas immunotherapy alone (Arm B). The median overall survival for patients receiving the combination was 6.1 months compared to 3.9 months for those receiving GVAX monotherapy (HR=0.54, one-sided p=0.011). Moreover, the immunotherapies were well-tolerated, with no treatment-related serious adverse events or unexpected toxicities observed.
For more information about the clinical trial, please visit ClinicalTrials.gov (Identifier: NCT02004262).
About Aduro BioTech
Aduro BioTech, Inc. is a clinical-stage biotechnology company focused on immunotherapy for cancer. Aduro has ongoing clinical trials in pancreatic cancer, mesothelioma and glioblastoma, and the company’s pipeline includes programs in non-small-cell lung cancer, ovarian cancer and prostate cancer. In addition, the company is developing clinical candidates that utilize small molecules that activate STING (stimulator of interferon genes), a central mediator of the innate immune response. For more information, please visitwww.adurobiotech.com.
Aduro BioTech, Inc.
Greg Schafer, 510-809-4801
Chief Operating Officer