MedImmune to collaborate with Ventana for PD-L1 assay

Companies will seek to develop an assay to enroll patients in MedImmune's MEDI4736 clinical trials for non-small cell lung carcinoma

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TUCSON, Ariz.—A new collaboration has been announced between MedImmune, the global biologics research and development arm of AstraZeneca, and Ventana Medical Systems, Inc., a member of the Roche Group. The companies will jointly develop a PD-L1 (SP263) immunohistochemistry assay for the enrollment of patients in clinical trials for MedImmune’s MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. This will include the MEDI4736 ATLANTIC trial, which began recently and will only enroll patients who express PD-L1 as determined by the VENTANA assay. No financial terms for the collaboration were disclosed.
“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,” Dr. Edward Bradley, senior vice president of R&D and Oncology iMED Head at MedImmune, commented in a statement.
MedImmune’s MEDI4736 compound is an investigational, engineered, human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from this ligand enable tumors to avoid being detected by the immune system, and it is thought that targeting PD-L1 with MEDI4736 might prevent it from broadcasting signals to T cells to ignore tumors cells.
“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,” Doug Ward, vice president and Lifecycle Leader for the Ventana Companion Diagnostics business unit, said in a press release. “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 Investigational Use Only assay currently being developed to support MEDI4736 trials is based on a SP263 (Spring Bioscience) rabbit monoclonal antibody, and the PD-L1 (SP263) assay has been validated for use on the VENTANA BenchMark series of staining instruments. The testing for MedImmune’s trials is being conducted at Ventana’s Tucson companion diagnostics CAP/CLIA laboratory and certain testing sites.
This is the second agreement MedImmune has struck regarding MEDI4736 in recent months. In May, the company announced the launch of a clinical study collaboration with Incyte Corporation for a Phase 1/2 oncology study that will evaluate MEDI4736’s safety and efficacy in combination with INCB24360, Incyte’s oral indoleamine dioxygenase-1 inhibitor. INCB24360 enhances the ability of immune cells to combat tumors, and MedImmune and Incyte will evaluate the combination of the compounds in multiple solid tumors, including metastatic melanoma, non-small cell lung cancer, pancreatic cancer and squamous cell carcinoma of the head and neck. The Phase 1 portion of the trial will seek to establish a recommended dosing regimen for MEDI4736 and INCB24360 while the Phase 2 portion will determine the safety and efficacy of combining the drug candidates. Incyte will conduct the study, which both companies will co-fund equally.
“Research collaborations that evaluate combinations of novel immunotherapies across a broad range of indications have the potential to accelerate our understanding of this rapidly evolving field, to identify new areas of opportunity for immunotherapies, and to more rapidly address the unmet needs of patients with a wide range of cancers,” Hervé Hoppenot, president and CEO of Incyte, said in a press release regarding the deal. “For these reasons, we welcome the opportunity to work with MedImmune to explore the potential of combining MEDI4736 with INCB24360.”

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