AstraZeneca Buys Definiens in Bid for Ground-Up Co-Diagnostics Pipeline

By Aaron Krol

November 5, 2014 | AstraZeneca this week announced that it has acquired Definiens, a diagnostics company specializing in image analysis software, as part of a strategy to generate early clues on patient stratification and companion diagnostics for its immuno-oncology programs. The deal was executed by AZ subsidiary MedImmune, which among other oncology leads has an extensive program around the PD-L1 inhibitor MEDI4736, including a Phase III trial as a standalone drug in non small cell lung cancer, and several early stage studies in combination with other compounds. MedImmune will pay $150 million up front for Definiens, and has committed to additional milestone payments.

Companion diagnostics based on genetic and protein markers are increasingly a foundational part of cancer drug discovery, but in purchasing Definiens, AstraZeneca is laying a bet on a very different co-diagnostic strategy. Definiens’ flagship platform, the Cognition Network Technology, examines tissue slides in much the same way as a human pathologist, looking for telltale visual signs that can subtype a disease or suggest a prognosis. The difference is that the Cognition Network Technology can perform a more quantitative analysis of images to pick up signals invisible to the human eye, or retrospectively scan thousands of patient samples to discover new biomarkers.

“We create tremendous amounts of data,” Thomas Heydler, CEO of Definiens, once told Bio-IT World sister site Clinical Informatics News. “I would absolutely compare the data volume with the genomics data volume on a patient... There’s tremendous value in the tissue, which is not uncovered yet because no technology was able to unearth the powerful information that sits in tissues.”

A recent success for the approach was a successful clinical study of Metamark’s ProMark test, using Definiens software, which analyzes prostate cancer tissue samples to recommend either watchful waiting or aggressive intervention. Metamark began offering ProMark nationwide as a laboratory developed test this October.

Definiens, which has lately been stressing its interest in immunotherapies (as in this Bio-IT World guest commentary by CMO Ralf Huss), seems to be a good fit for AstraZeneca’s programs around drugs like MEDI4736. These therapies rely on boosting a sluggish immune response to cancer cells, and are more appropriate for patients whose immune systems are only weakly active in the area of their tumors — something that could plausibly be divined through image analysis. AstraZeneca is hoping that Definiens software could be used very early on to target the right patient populations, or to refocus trials that are showing a response in only a small subset of participants.

At Fierce Biotech, however, John Carroll wonders out loud whether AstraZeneca — “undergoing a massive, years-long R&D makeover” — can give the still-emerging Definiens platform the attention it deserves. Definiens has done interesting work giving the Cognition Network Technology contextual awareness of tissue images, and helping it zero in on meaningful sections of tissue, but it is unclear whether the platform is yet ready to stand on its own as a companion diagnostic, alongside more familiar gene- and protein-based markers.