Aduro BioTech, Inc. announces the enrollment of the first patient in the Phase 1B clinical trial of Aduroâ€™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 Aduroâ€™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.
â€śWe 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,â€ť said Dr. Dirk Brockstedt, Senior Vice President of Research and Development at Aduro. â€śThis 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.â€ť
About Aduro BioTech, Inc.
Aduro is advancingÂ multiple therapeutic and prophylactic vaccines for cancer and infectiousÂ diseases based on its proprietary attenuatedÂ Listeria monocytogenes vaccineÂ platforms.Â The company is alsoÂ advancing a new program towards clinical evaluationÂ that utilizes targeted small molecule immune modulators that have broad application for vaccine design. TheÂ company'sÂ ListeriaÂ platform has beenÂ validated by 26 publications that illustrate the platform's unique combinationÂ of safety and potency, and the platform has received moreÂ than $24 million in federal and private grantÂ and contract funding. In addition, theÂ company has multiple patents issued in the U.S., Europe and throughout theÂ world that broadly protectÂ its proprietary and clinical applications. The companyâ€™s lead therapeutic, CRS-207, isÂ currently being evaluated in a randomized, controlled Phase 2 trial in patientsÂ with metastaticÂ pancreatic cancer and a Phase 1 clinical trial in patients with malignant pleural mesothelioma.Business Wire
Last updated on: 02/10/2012