PD-L1 (SP263)

AstraZeneca’s global biologics R&D arm MedImmune and Ventana Medical Systems (Ventana), a member of the Roche Group, are jointly developing a PD-L1 (SP263) immunohistochemistry assay to enrol patients in clinical trials for MedImmune’s MEDI4736 anti-PD-L1 therapy for treating non-small cell lung carcinoma (NSCLC).

The development includes the recently started MEDI4736 ATLANTIC trial, which will enrol only patients who express PD-L1 as determined by the Ventana assay.

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According to Ventana, the investigational, engineered, human monoclonal antibody ‘MEDI4736’ is directed against programmed cell death ligand 1 (PD-L1).

Signals from PD-L1 help tumours avoid detection by the immune system and it is believed that by targeting PD-L1, MEDI4736 might block this ligand from sending out signals to T-cells to ignore tumour cells, thereby countering cancer’s immune-evading tactics.

The PD-L1 investigational use only (IUO) assay in development that is supporting MEDI4736 trials is based on a SP263 (Spring Bioscience) rabbit monoclonal antibody.

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Ventana Companion Diagnostics business unit VP and lifecycle leader Doug Ward said cancer immunotherapy is a promising area that may provide long lasting benefit not achieved with other treatment approaches.

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"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."

"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," Ward said.

"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."

The PD-L1 assay has been authorised for use on the Ventana BenchMark series of advanced staining instruments deployed globally, while testing for MedImmune’s trials is being carried out at the Ventana companion diagnostics (CDx) CAP/CLIA laboratory in Tucson, Arizona, US, and select testing sites.

MedImmune senior vice-president, R&D and oncology iMED head Edward Bradley said: "Personalised 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 programme."

The Ventana CAP/CLIA lab employs automated staining platforms and validated assays for IHC and ISH staining of retrospective and prospective clinical samples.

Image: PD-L1 (SP263) – Positive Lung tissue at 20x magnification, stained on a BenchMark ULTRA instrument. Photo: courtesy of Ventana Medical Systems.