BERKELEY, Calif., June 29, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that an independent Data Monitoring Committee (DMC) recommended that the Phase 2b ECLIPSE trial of its novel LADD and GVAX immunotherapies continue as planned without modification based on the successful outcome of a pre-specified futility analysis. The DMC assessment included an evaluation of interim primary efficacy and safety data from over half of the anticipated patient population enrolled in the trial.
The randomized, controlled three-arm trial is expected to enroll over 300 patients at 21 clinical trial sites in the United States and Canada to evaluate the safety, immune response and efficacy of the combination immunotherapy of CRS-207 in combination with GVAX Pancreas compared to chemotherapy. The trial also has 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 have received one prior therapy for metastatic disease is also being evaluated.
"Given the very difficult-to-treat nature of metastatic pancreatic cancer, we are pleased with the DMC's recommendation to continue the ECLIPSE trial without modification following their review of interim data," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We are on track to complete enrollment in the primary cohort of the trial in the third quarter of this year and look forward to announcing top line results in the first half of 2016."
Last year, 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. 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.
Breakthrough Therapy designation was granted based on results from a Phase 2a clinical trial of patients with metastatic pancreatic cancer treated with CRS-207 and GVAX Pancreas. The multi-center trial, which enrolled 93 patients with metastatic pancreatic cancer, demonstrated a statistically significant survival benefit in patients receiving the combination immuno-oncology regimen of CRS-207 and GVAX Pancreas compared to GVAX Pancreas alone. The results were published in the January 2015 issue of the Journal of Clinical Oncology (JCO).
Results of the Phase 2a clinical trial published in 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). One-year survival probability for patients in Arm A was 24 percent compared with 12 percent for patients in Arm B. The trial enrolled advanced-stage metastatic pancreatic cancer patients who previously received or refused prior chemotherapy, with most patients having received two or more prior therapies in the metastatic setting. Patients were randomized in a 2:1 ratio to receive two doses of GVAX Pancreas vaccine followed by four doses of CRS-207 (Arm A) or to receive six doses of GVAX Pancreas vaccine alone (Arm B). Clinically stable patients were allowed to receive additional treatment courses.
Of the 93 patients enrolled, the most frequent treatment-related Grade 3 or 4 adverse event (AE) was asymptomatic, transient lymphopenia, with three patients experiencing Grade 3 lymphopenia and two patients experiencing Grade 4 lymphopenia. There were no other Grade 4 AEs, and there were no other Grade 3 AEs with frequencies higher than five percent in either arm. The most common Grade 3 AEs were transient lymphopenia, fevers, elevated liver enzymes and fatigue.
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 vaccines 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.
Aduro Biotech, Inc. is a clinical-stage immuno-oncology company focused on the development of technology platforms to stimulate an immune response against cancer. Aduro's lead platform is based on proprietary strains of live-attenuated, double-deleted (LADD) Listeria monocytogenes that induce a potent innate immune response and have been engineered to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. Aduro has received Breakthrough Therapy designation from the FDA for its lead LADD regimen, CRS-207 in combination with GVAX Pancreas in pancreatic cancer. The company is evaluating the proprietary immuno-oncology combination in the ongoing Phase 2b ECLIPSE clinical trial and has additional ongoing clinical trials with its LADD platform in mesothelioma and glioblastoma. The company is also developing clinical candidates using cyclic dinucleotide (CDN) synthetic small molecule immune modulators that are designed to activate the intracellular STING receptor, a central mediator of the innate immune response. For more information, please visit www.aduro.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for CRS-207 in combination with GVAX Pancreas, plans and timing of our ECLIPSE clinical trial and the potential for eventual regulatory approval, commercialization and launch of our product candidates. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in the most recent Form 10-Q which is on file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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