Leica, Merrimack ink CDx deal

NEWCASTLE UPON TYNE, England & CAMBRIDGE, Mass.—Leica Biosystems and Merrimack Pharmaceuticals have announced a strategic partnership for the development of companion diagnostic assays to help identify patients that might best respond to current and future oncology therapies developed by Merrimack. Specifically, the companies will use Advanced Cell Diagnostics' (ACD's) RNAscope technology to design the assays, which will then be processed on Leica Biosystems' BOND clinical advanced staining systems.

"We are pleased to be working with Merrimack on cancer therapies with the BOND platform," Dr. Matthias Weber, president of Leica Biosystems, commented in a statement. "The partnership utilizing RNAscope technology is an example of Leica Biosystems paving the way for in-situ RNA detection in personalized medicine. The ease of use and high quality staining delivered by BOND systems makes them ideal platforms on which to deploy these very informative tests."

Initially, Leica and Merrimack will focus on developing a companion diagnostic assay for Merrimack's investigational therapy seribantumab, also known as MM-121. Seribantumab is a fully human, monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin (HRG). Heregulin-driven ErbB3 signaling identifies a unique, more difficult to treat cancer phenotype characterized by increased tumor growth as well as increased resistance to targeted, cytotoxic and anti-endocrine therapies. The compound is currently being investigated primarily in combination settings, to block HRG activated ErbB3 signaling in order to enhance the anti-tumor effect of the combination therapy partner.

"Our increased understanding of cancer cell biology is driving the need for companion diagnostic tests to ensure the right patients get the right therapies," Jason Baum, director of Companion Diagnostics at Merrimack, said in a press release. "The use of RNAscope technology on Leica Biosystems' automated staining platforms will allow us to detect HRG with high sensitivity and specificity, helping to identify the patients most likely to benefit from seribantumab treatment. HRG is the cognate ligand of the ErbB3 receptor and a powerful driver of cell survival signaling. HRG tumor expression has been implicated in defining a distinct, difficult to treat cancer phenotype that is found across multiple solid tumors at a prevalence rate of approximately 30 to 50 percent in major indications. We are pleased to have partnered with Leica Biosystems on this project."

This is the second companion diagnostic partnership for Leica so far this year. In January, the company announced that it would be teaming up with Advanced Cell Diagnostics Inc. to develop and commercialize tissue-based diagnostic tests based on ACD's RNAscope in-situ hybridization assays on Leica Biosystems' BOND clinical advanced staining instruments.