Date: 2014-06-04
Type of information: Development agreement
Compound: PD-L1 (SP263) immunohistochemistry assay for MEDI4736 anti-PD-L1 immunotherapy's clinical trials
Company: Medimmune (USA - global biologics arm of AstraZeneca (UK) - Ventana Medical Systems,(USA), a member of the Roche Group (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism: monoclonal antibody/immune checkpoint inhibitor. MEDI4736 is an investigational, engineered, human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. It is believed that by targeting PD-L1, MEDI4736 may block this ligand from sending out signals to T-cells to ‘ignore’ tumor cells, thereby countering cancer’s immune-evading tactics. The PD-L1 Investigational Use Only (IUO) assay in development that is supporting MEDI4736 clinical trials is based on a SP263 (Spring Bioscience) rabbit monoclonal antibody.
Disease: non-small cell lung carcinoma
Details: * On June 4, 2014, MedImmune, the global biologics research and development arm of AstraZeneca, and Ventana Medical Systems, a member of the Roche Group, announced they are jointly developing a PD-L1 (SP263) immunohistochemistry assay to enroll patients in clinical trials for MedImmune’s MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This includes the recently commenced MEDI4736 ATLANTIC trial that will enroll only patients who express PD-L1 as determined by the VENTANA assay. The PD-L1 (SP263) assay has been validated for use on the VENTANA BenchMark series of advanced staining instruments deployed globally. Testing for MedImmune’s trials is being performed at the Ventana companion diagnostics (CDx) CAP/CLIA laboratory in Tucson, Arizona, USA and select testing sites.
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