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Leica Biosystems and Merrimack Pharmaceuticals to Collaborate on Development of a Heregulin Companion Diagnostic for Seribantumab

NEWCASTLE UPON TYNE, UK and CAMBRIDGE, MASSACHUSETTS, USA, April 14, 2016. Leica Biosystems and Merrimack Pharmaceuticals (NASDAQ: MACK) today announced a strategic partnership to develop companion diagnostic assays to aid in identification of patients who might best respond to current and future oncology therapies developed by Merrimack. The assays will be designed using Advanced Cell Diagnostics’ (ACD’s) RNAscope technology and will be processed on Leica Biosystems’ BOND clinical advanced staining systems.

The initial focus of this partnership will be the development of a companion diagnostic assay for Merrimack’s seribantumab, or MM-121, an investigational therapy. Seribantumab is a fully human, monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling identifies a unique, more difficult to treat cancer phenotype characterized by increased tumor growth and increased resistance to targeted, cytotoxic and anti-endocrine therapies. Seribantumab is 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.  

“We are pleased to be working with Merrimack on cancer therapies with the BOND platform,” added Matthias Weber MD, President of Leica Biosystems. “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.”    

“Our increased understanding of cancer cell biology is driving the need for companion diagnostic tests to ensure the right patients get the right therapies,” said Jason Baum, Director, Companion Diagnostics at Merrimack. “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 30-50% in major indications. We are pleased to have partnered with Leica Biosystems on this project.”

Leica Biosystems’ work program will be led from their Companion Diagnostics Research and Development site in Danvers, Greater Boston, Massachusetts, with kit manufacturing occurring in Newcastle.

About Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit for more information.

About Merrimack
Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE® (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at or connect on Twitter at @MerrimackPharma.

Forward-Looking Statements: Merrimack This release includes forward-looking statements concerning seribantumab, a companion diagnostic for that therapy and the related collaboration between Leica Biosystems and Merrimack, including expectations with respect to development, timing and potential impact to patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical trial results; changes in laws and regulations; issues with product quality, manufacturing or supply; patient safety issues; and other risks identified in Merrimack’s most recent filing on Form 10-K and other SEC filings.  Merrimack does not undertake to update its forward-looking statements.