Ventana Medical Systems, Inc. and MedImmune Collaborate to Develop a Custom PD-L1 Assay for Immunotherapy Clinical Trials

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group and MedImmune, the global biologics research and development arm of AstraZeneca, today 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.

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.

Immunotherapy Development
"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," says Doug Ward, VP and Lifecycle Leader for the Ventana Companion Diagnostics business unit. "We're proud to provide high quality reagents like SP263 to support MedImmune's immunotherapy development efforts to advance the standard of care for cancer patients."

Companion Diagnostics
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.

"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," said Dr. Edward Bradley, Senior Vice President, R&D and Oncology iMED Head, MedImmune.

Since 2002 Ventana has worked with more than 45 biopharmaceutical partners and is currently engaged in more than 180 collaborative projects to develop and commercialize companion diagnostics globally. The company has a global install base of over 10,000 automated platforms that run advanced cancer diagnostic tests to benefit patients.