Date: 2015-12-10
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-64041757/ADU-214
Action
mechanism: immunotherapy product/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.
Disease: non small cell lung cancer
Therapeutic area:
Country: USA
Trial
details: This open-label phase 1 study evaluates the safety and mmunogenicity of JNJ-64041757, a live attenuated Listeria Monocytogenes immunotherapy, in subjects with non-small cell lung cancer. The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of JNJ-64041757 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 advanced (Stage IIIb) or metastatic (Stage IV) NSCLC (adenocarcinoma). (NCT02592967)
Latest
news: * On December 10, 2015, Aduro Biotech announced the start of the Phase 1 study of ADU-214 (also known as JNJ-64041757), a LADD immuno-oncology therapy for the treatment of lung cancer, with the dosing of the first patient in the trial. Janssen Biotech, Inc., Aduro’s license partner for ADU-214, is conducting the multi-center study. The Phase 1 study will evaluate intravenous administration of ADU-214 in patients with advanced or metastatic non-small cell lung cancer. The trial is expected to enroll up to 40 patients, approximately 12 of whom will participate in the dose escalation portion of the trial where two dose levels of ADU-214 will be evaluated for safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity in an additional 30 patients.
