FDAnews
www.fdanews.com/articles/165043-ventana-medical-systems-and-medimmune-to-develop-cancer-assay

Ventana Medical Systems and MedImmune to Develop Cancer Assay

June 6, 2014

Ventana Medical Systems and MedImmune are jointly developing a PD-L1 (SP263) immunohistochemistry assay for use in selecting patients for clinical trials of MedImmune's MEDI4736 anti-PD-L1 therapy for non-small cell lung cancer.

This includes the recently launched MEDI4736 Atlantic trial, which will enroll about 210 patients who express PD-L1, as determined by the Ventana assay, MedImmune spokeswoman Tracy Rossin told Device Daily Bulletin.

The investigational human monoclonal antibody MEDI4736 is intended to treat NSCLC by targeting programmed cell death ligand 1 (PD-L1), the companies said. PD-L1 emits signals that help tumors avoid detection by the immune system. MEDI4736 is believed to block PD-L1 from sending signals that tell T-cells to overlook tumor cells.

The PD-L1 assay is for investigational use only and is based on an SP263 (Spring Bioscience) rabbit monoclonal antibody, the companies said.

MedImmune has numerous studies underway with MEDI4736, both in monotherapy and in combination with other molecules, Rossin said. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.