Phase 1 study results of Aduro BioTech's CRS-207 presented at AACR Conference on Tumor Immunology

Dec 7 2010

Aduro BioTech, a clinical-stage immunotherapy company, is pleased to announce the presentation of the CRS-207 Phase 1 study at the AACR Special Conference on Tumor Immunology in Miami, Florida by the Principal Investigator, Dr. Dung Le of the Johns Hopkins Kimmel Cancer Center. Dr. Le reported that CRS-207 intravenous administration was well tolerated in subjects with advanced, treatment-refractory cancers. Dr. Le also reported evidence of immune activation and that 6 out of 17 end-stage cancer patients lived 15 months or longer.

“Not only do we have promising results from Phase 1, we are working with an outstanding team of physicians, including Drs. Dung Le and Elizabeth Jaffee at the Johns Hopkins Kimmel Cancer Center in Baltimore and Dr. Ran Nir-Paz at Hadassah Hebrew-University Hospital in Jerusalem.”

CRS-207 is based on Aduro BioTech's live-attenuated, double-deleted (LADD) Listeria monocytogenes (Lm) 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 clinical samples and in animal models to be an important target for immunotherapy. CRS-207 was evaluated in a Phase 1 trial in 17 subjects with cancers known to express mesothelin: mesothelioma, non-small-cell lung, pancreatic and ovarian.

Multiple intravenous infusions of CRS-207 were well tolerated up to 1×10⁹ cfu, which was determined to be the maximum tolerated dose. The dose-limiting toxicity in the 1×10¹⁰ cfu cohort was hypotension. Importantly, no shedding of the vaccine strain was detected in any of the patients.

Analysis after the completion of the trial revealed a mesothelin-specific T cell response and that 6 out of 17 subjects with advanced, treatment-refractory cancers lived 15 months or longer.

"We feel that we are in a strong position to advance CRS-207 into Phase 2," said Stephen Isaacs, Chairman and CEO of Aduro BioTech. "Not only do we have promising results from Phase 1, we are working with an outstanding team of physicians, including Drs. Dung Le and Elizabeth Jaffee at the Johns Hopkins Kimmel Cancer Center in Baltimore and Dr. Ran Nir-Paz at Hadassah Hebrew-University Hospital in Jerusalem."

SOURCE Aduro BioTech