Date: 2015-12-21
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Janssen Research & Development, a J&J company (USA - NJ)
Product: JNJ-64041809/ADU-741
Action
mechanism: immunotherapy product/therapeutic vaccine/cell therapy. LADD immuno-oncology platform 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. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer), ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).
Disease: metastatic castration-resistant prostate cancer (mCRPC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This open-label phase 1 study aims to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC). (NCT02625857)
Latest
news: * On December 21, 2015, Aduro Biotech announced that the first patient in the Phase 1 study of ADU-741 (also known as JNJ-64041809), a LADD immunotherapy product candidate for the treatment of prostate cancer, has been dosed. The Phase 1 study will enroll approximately 40 patients with metastatic castration-resistant prostate cancer. The initial dose escalation portion of the trial, with two dose levels of ADU-741, will evaluate safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity.
