Clinical Cancer Research publishes results of Aduro's ANZ-100 and CRS-207 Phase 1 studies

Aduro BioTech, Inc. is pleased to announce the publication of two therapeutic cancer vaccine Phase 1 studies in Clinical Cancer Research (volume 18(3), pages 1-11). In the article, which was featured as one of the highlights of the issue, Dr. Dung Le et al. reported that intravenous administration of ANZ-100 and CRS-207 was well tolerated in subjects with advanced, treatment-refractory cancers. Le et al. also reported evidence of immune activation, induction of tumor-specific immunity and that 37% of end-stage cancer subjects treated with CRS-207 lived 15 months or longer.

ANZ-100 is the first clinical candidate based on Aduro's live-attenuated, double-deleted (LADD) Listeria monocytogenes vaccine platform, which has been engineered to be safe for human use through deletion of two virulence determinants (actA and inlB) that attenuate the ability of the microorganism to invade non-phagocytic cells and to spread from cell to cell. CRS-207 is further engineered to express mesothelin, which has been shown in humans and animal models to be an important target for immunotherapy.

ANZ-100 was evaluated in a single-dose study in 9 subjects with liver metastases. CRS-207 was evaluated in a multiple-dose study in 17 subjects with cancers known to over-express mesothelin: mesothelioma, non-small-cell lung, ovarian and pancreatic. A dose range was identified in both clinical studies that is safe and induces a specific immune response.

Additional analysis of the CRS-207 trial revealed a mesothelin-specific T cell response and that, despite life expectancies of only 3-6 months, 37% of subjects with metastatic, treatment-refractory cancers lived 15 months or longer. Based on these promising data, Aduro is currently evaluating CRS-207 in a randomized, controlled Phase 2 clinical trial in patients with metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01417000).

"This publication shows the safety and potential potency of our LADD therapeutic vaccine platform," said Stephen Isaacs, Chairman and CEO of Aduro BioTech, Inc. "We envision multiple near-term product opportunities in oncology."