TUCSON, Ariz.—Ventana Medical Systems, Inc., a member of the Roche Group, has established an agreement with Merck KGaA, which operates as EMD Serono in the United States and Canada, to collaborate on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana’s proprietary diagnostic assays. The aim is to develop a patient-stratifying diagnostic test with utility in multiple cancer indications. Ventana will help to develop and validate the companion diagnostic and evaluate its readiness, availability and adherence to the standards of the U.S. Food and Drug Administration and other health authorities for future clinical trials. No financial details were disclosed.
“Tailoring therapies based on a patient’s specific genes, proteins or tissue environment is a key expansion area for oncology. We are very pleased to partner with Merck in Darmstadt, Germany to co-develop a CDx that will play a vital role in improving the quality of care for cancer patients,” Doug Ward, vice president of Companion Diagnostics for Ventana Medical Systems, commented in a statement. “Ventana is committed to continuing to provide the industry’s gold standard in biomarker detection using our proprietary assays as the basis for novel companion diagnostic tests.”
The agreement follows on the heels of two other cancer-focused deals announced by Ventana in the past few months. In early June, the company announced another cancer-focused deal, this one with MedImmune, AstraZeneca’s global biologics research and development arm. The two companies will jointly develop a PD-L1 (SP263) immunohistochemistry assay to aid in the enrollment of patients in clinical trials for MedImmune’s MEDI4736 anti-PD-L1 therapy for non-small cell lung carcinoma. The agreement includes the recently begun MEDI4736 ATLANTIC trial, which will enroll only patients expressing PD-L1 as determined by the Ventana assay.
MEDI4736 is an investigational engineered, human monoclonal antibody that targets programmed cell death ligand 1 (PD-L1), whose signals aid tumors in avoiding detection by the body’s immune system. The belief is that by targeting this ligand, the compound could block PD-L1’s signals to T cells to ignore tumor cells, which would remove cancer cells’ ability to avoid destruction by the immune system. The PD-L1 Investigational Use Only assay being developed to support MEDI4736 trials is based on an SP263 (Spring Bioscience) rabbit monoclonal antibody. Ventana has validated the PD-L1 (SP263) assay for use on the Ventana BenchMark series of advanced staining instruments.
Ventana signed another agreement in April, this one with Genmab A/S, to develop companion diagnostic tools for Genmab's HuMax-TF-ADC antibody drug conjugate program. Ventana will help with the development of an immunohistochemistry companion diagnostic test for detecting tissue factor in patients’ tumor samples, and the assay will be developed for possible designation as a screening test in clinical trials that involve HuMax-TF-ADC.
