Additional Posters Presented on the Ongoing Phase 2 STELLAR Trial in Pancreatic Cancer and a Phase 1 Trial in Glioblastoma Multiforme to Evaluate Safety and Efficacy of Aduro's LADD-Based Immunotherapies
BERKELEY, Calif., June 1, 2015 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO) today announced the presentation of interim safety and efficacy data from an ongoing Phase 1b clinical trial of its novel immunotherapy CRS-207 in combination with standard chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). Of the 32 evaluable patients, disease control was observed in 94% (30/32), including 60% (19/32) with partial responses and 34% (11/32) experiencing stable disease following treatment with CRS-207 and chemotherapy. The results were presented by Raffit Hassan, M.D., co-chief of the Thoracic and GI Oncology Branch at the National Cancer Institute, in a poster presentation (abstract #7565) at the 2015 American Society of Clinical Oncology Meeting (ASCO) held in Chicago.
"The data in this trial continue to support our rationale that Aduro's novel CRS-207 immunotherapy, when combined with standard chemotherapy, may elicit strong and durable responses in a particularly difficult-to-treat mesothelioma patient population," said Dr. Hassan. "I look forward to final data from this study and the potential to offer patients a promising alternative therapy."
Dirk G. Brockstedt, Ph.D., senior vice president of Research and Development at Aduro added, "Based on these encouraging results, we are expanding this Phase 1b trial to include a second cohort of patients who will receive low-dose cyclophosphamide with CRS-207 and standard chemotherapy. The addition of this cohort was based on favorable preclinical data, which indicated this combination may further enhance immune response and tumor-specific efficacy and overall survival. As we evaluate advancing our therapy into a later stage, randomized clinical trial for the treatment of mesothelioma, this new cohort will provide valuable information toward developing the best regimen to improve outcomes for patients."
At the time of the ASCO presentation, the multi-center Phase 1b study had enrolled 36 patients who were chemotherapy-naïve, had unresectable MPM, good performance status (ECOG 0 or 1) and adequate organ function. Under the trial design, eligible patients received two prime vaccinations with CRS-207 two weeks apart, followed by up to six cycles of standard of care pemetrexed and cisplatin chemotherapy three weeks apart and two CRS-207 boost vaccinations three weeks apart. Clinically stable patients receive CRS-207 maintenance vaccinations every eight weeks and are followed every eight weeks until disease progression. Objectives of the study are safety, immunogenicity, objective tumor responses and tumor marker kinetics.
The median time of treatment was 6.9 months (range: 0.3 – 26.2 months). Median duration of response was 5.0 months (95% CI: 3.7 – 11.5 months) and median progression free survival was 7.4 months (95% CI: 6.9 – 10.8 months). No treatment-related serious adverse events or unexpected toxicities were observed. Treatment, follow-up and immune response evaluations are ongoing.
Separately, two additional posters were presented at the ASCO meeting that provide details on the ongoing trials of Aduro's immunotherapies for the treatment of pancreatic cancer and grade 3/4 gliomas, including glioblastoma multiforme.
The first poster (abstract #TPS4148) highlighted the randomized, controlled STELLAR trial (Safety and Therapeutic Efficacy of Live-attenuated Listeria/GVAX with Anti-PD1 Regimen). The investigator-sponsored STELLAR trial will enroll approximately 88 adults with metastatic pancreatic cancer who have failed one prior chemotherapy regimen for metastatic disease. Patients are randomized equally to one of two arms: Arm A with CRS-207/GVAX Pancreas vaccine and nivolumab or Arm B with CRS-207/GVAX Pancreas vaccine. The primary objective of this study is to compare the overall survival of patients in Arm A and Arm B. Secondary endpoints include evaluation of clinical and immune response and safety. For more information, please visit ClinicalTrials.gov (Identifier: NCT02243371).
The second poster (abstract #TPS3106) provided an overview of the investigator-sponsored Phase 1 trial to evaluate the safety and immunogenicity of Aduro's ADU-623 in grade 3/4 gliomas (including anaplastic astrocytomas and glioblastoma brain cancers). This is a dose-escalation trial enrolling up to 18 patients. The primary objective of the trial is to identify the maximum tolerated dose and characterize the safety profile of the ADU-623 vaccine in patients with treated and recurrent grade 3/4 astrocytomas. For more information, please visit ClinicalTrials.gov (Identifier: NCT01967758).
About Malignant Pleural Mesothelioma
Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen. Malignant pleural mesothelioma (MPM), which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease and accounts for approximately 3,000 cases a year in the United States. MPM is an aggressive disease with a poor prognosis. Most MPM patients are not candidates for surgical resection. Based on prior studies, expected median time to progression is 5.7 months and median overall survival is 12.1 months with combination pemetrexed and cisplatin chemotherapy. The tumor-associated antigen mesothelin is overexpressed on the majority of mesothelioma tumors.
CRS-207 is one of a family of product candidates based on Aduro's live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induces a potent innate and T cell-mediated adaptive immune response. 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, endometrial and gastric cancers.
About LADD and ADU-623
LADD is Aduro's proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. ADU-623 is engineered to express EGFRvIII and NY-ESO-1, which are expressed in glioblastoma and other cancers.
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 our technology, plans and timing of our clinical trials 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.
CONTACT: Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264
925 202 6211