October 02, 2012 06:00 AM Eastern Daylight Time
BERKELEY, Calif. -- Aduro BioTech, Inc. announces the enrollment of the first patient in the Phase 1B clinical trial of Aduro’s CRS-207 therapeutic cancer vaccine combined with chemotherapy in patients newly diagnosed with malignant pleural mesothelioma (ClinicalTrials.gov Identifier NCT01675765). Patients will receive two prime vaccinations with CRS-207, followed by standard-of-care chemotherapy (pemetrexed and cisplatin) and at least 2 boost vaccinations after chemotherapy. The trial is being conducted at two sites: the National Cancer Institute (NCI) in Bethesda, Maryland (under a Cooperative Research and Development Agreement) and the H. Lee Moffitt Cancer Center in Tampa, Florida.
CRS-207 is based on Aduro’s platform of attenuated Listeria monocytogenes (Listeria) strains that have been genetically modified and engineered to induce a potent immune response specific for the mesothelin tumor-associated antigen that is expressed on certain tumor types, including mesothelioma, non-small-cell lung, ovarian and pancreatic cancer. The vaccine was evaluated in a Phase 1 trial in 17 patients with end-stage cancer of these types and the results were recently published in Clinical Cancer Research (volume 18(3), pages 1-11). Despite a historical average survival time of only 3-5 months for this advanced-cancer patient population, six out of 17 patients treated with CRS-207 in this Phase 1 trial lived 15 months or longer. These promising results have led to two ongoing clinical trials with CRS-207: the Phase 2 clinical trial in patients with metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01417000) and the new Phase 1B trial in patients with malignant pleural mesothelioma.
“We are excited to be expanding our Listeria-based platform into a new indication, and extending our collaborations with leading mesothelioma translational researchers, Dr. Raffit Hassan, Senior Investigator at the NCI, and Dr. Scott Antonia, Professor and Chair of Thoracic Oncology at the Moffitt Cancer Center in Tampa,” said Dr. Dirk Brockstedt, Senior Vice President of Research and Development at Aduro. “This trial will evaluate our vaccine treatment for the first time in front-line cancer patients, and we predict a synergistic benefit to their standard chemotherapy.”
About Aduro BioTech, Inc.
Aduro is advancing multiple therapeutic and prophylactic vaccines for cancer and infectious diseases based on its proprietary attenuated Listeria monocytogenes vaccine platforms. The company is also advancing a new program towards clinical evaluation that utilizes targeted small molecule immune modulators that have broad application for vaccine design. The company's Listeria platform has been validated by 26 publications that illustrate the platform's unique combination of safety and potency, and the platform has received more than $24 million in federal and private grant and contract funding. In addition, the company has multiple patents issued in the U.S., Europe and throughout the world that broadly protect its proprietary and clinical applications. The company’s lead therapeutic, CRS-207, is currently being evaluated in a randomized, controlled Phase 2 trial in patients with metastatic pancreatic cancer and a Phase 1 clinical trial in patients with malignant pleural mesothelioma.
Aduro BioTech, Inc.
Steven Bodovitz, Ph.D., +510-809-4813