Tapping CDx expertise

 

The collaboration with Merck KGaA involves working with the German company’s biopharmaceutical division on the development and commercialization of a test for an undisclosed target using Ventana’s proprietary diagnostic assays. “Our ultimate goal is to develop a patient-stratifying diagnostic test that can be used in multiple cancer indications in support of Merck’s targeted therapies and to develop and validate the test to ensure its readiness, availability and adherence to FDA standards as well as other health authority standards for future clinical trials,” Doug Ward, vice president and lifecycle leader for the Ventana Companion Diagnostics business unit, tells DDNews. “Our joint teams have worked very well together in the past, and we are both very excited about what we can accomplish for patients moving forward.”

 

The collaboration is part of Merck KGaA’s strategy to embrace a personalized treatment approach to cancer patients by pursuing methods of identifying patients who are more likely to benefit from a specific treatment in order to achieve the best possible medical outcome. Merck KGaA is actively investing in innovation in the companion diagnostic field through a number of partnerships and plans to leverage Ventana’s expertise in cancer diagnostics to achieve new levels of diagnostic clarity for the investigated target.

 

The companies point to several advantages that could result from incorporating a companion diagnostic strategy into the drug development program, including the potential for an expedited drug approval process and the likelihood of more effective treatments with improved safety profiles. The financial terms of the agreement have not been disclosed.

 

This is one of several partnerships currently underway for Ventana’s companion diagnostics team. The company has entered similar partnerships with Bayer, Pfizer, Boehringer Ingelheim, Genmab, Incyte and MedImmune, among others. “In the last decade we have worked with more than 45 biopharmaceutical companies and are currently engaged in more than 180 collaborative projects to develop and commercialize companion diagnostics,” says Ward.

 

The collaboration with Merck KGaA extends beyond the clinical trial process and will also involve working together to support the companies’ pre-launch, launch and commercialization requirements. Ventana views the partnership as part of its strategy to extend the range and quality of its diagnostic products. “The ongoing development of high-medical-value assays helps to insure our menu of more than 250 different cancer diagnostic tests remains relevant, innovative and on the cutting edge of diagnostic technology,” says Ward.

 

“Now that we’ve reached agreement with Merck KGaA, we’ve established mutual goals and objectives for product development, project management and collaboration across our teams,” says Ward. “We’re both looking forward to moving into the next phase of product development.”

 

Ventana saw another milestone this summer in the expansion of its companion diagnostic testing program with the announcement of a new partnership in China. The company signed an agreement with Quintiles, a biopharma services company, to offer College of American Pathology-standard companion diagnostic testing services in China for pharmaceutical and biotech companies conducting early-phase clinical trials. The agreement is particularly significant due to the Chinese government requirement that all patient samples be tested in China, even those used in clinical trials. China is currently the only country with such a requirement, while it also has the highest rate of new cancer cases, according to the World Health Organization’s 2012 World Cancer Report.