MedImmune And Ventana Collaborate On Custom Assay For Clinical Trial
AstraZeneca global biologics R&D arm MedImmune and Roche Group member Ventana Medical Systems announced that the companies have agreed to co-develop an immunohistochemistry assay to enroll patients in MedImmune’s clinical trial investigating its MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma (NSCLC).
The PD-L1 Investigational Use Only (IUO) assay is based on the SP263 (Spring Bioscience) rabbit monoclonal antibody. The custom assay is currently under development and is supporting MEDI4736 clinical trials. The trials will include the recently completed ATLANTIC trial, which will accept only patients who express PD-L1 as verified by the Ventana assay. The assay has received validation to be used on the VENTANA BenchMark series.
“Cancer immunotherapy is a promising area that may provide long lasting benefit not achieved with other treatment approaches. This collaboration is another strong example of the importance of companion diagnostics and their role in supporting the use of novel immunotherapies to target human malignancies,” said Doug Ward, VP and lifecycle leader for the Ventana Companion Diagnostics business unit. Ward said that the company continues to work towards advancing care for cancer patients by supplying high quality reagents to support its partner’s immunotherapy development programs.
Dr. Edward Bradley, SVP of R&D and Oncology iMED head at MedImmune, said, “Personalized healthcare is an important part of our development strategy, so we are pleased to collaborate with Ventana on this companion diagnostic to help further advance our MEDI4736 development program.”
The trials are being conducted at the Ventana companion diagnostics (CDx) CAP/CLIA laboratory in Tucson, Arizona, and other testing sites. The company also launched three new companion diagnostic robust prototype assays (RPAs) last month. The assays are designed for the detection of biomarkers PSMA, MDM2, and FGFR and offer biotech and pharmaceutical companies a range of new tools to explore innovative treatment options for patients with cancer.