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Now Part of AstraZeneca, Definiens Concentrating on CDx, Ramp up into Clinical Space

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NEW YORK (GenomeWeb) – With its acquisition by AstraZeneca's MedImmune business completed, Definiens' focus will be on developing companion diagnostics and furthering its entry into the clinical space. 

The deal for at least $150 million closed in late November, providing MedImmune access to Definiens' technology, dubbed "tissue phenomics." While MedImmune, the biologics R&D arm of AstraZeneca, has plans to use the technology to develop tools for prognostic use, Definiens CEO Thomas Heydler told GenomeWeb that the more immediate goal is to combine each firm's capabilities to develop diagnostics to help determine which patients would benefit from certain therapies in development.

Definiens' technology "can really complement what [MedImmune] is doing to better understand the cancer, better understand the tumor, [and] to accelerate the process and the [drug development] pipeline," Heydler said. The technology will "provide significantly more valuable information to stratify patients to make them targeted by the various monotherapy and combination therapies," he added, noting that the CDx market that his firm plans to address is anticipated to grow to about $1 billion in the next few years.

"As you are able to stratify patients in a much better way, you can significantly accelerate [existing] programs, and at the end of the day, you have a high impact once the therapy gets into the clinical routine," and a companion diagnostic is used with the therapy, he said.

While Heydler declined to say which drugs in AstraZeneca's and MedImmune's pipeline are being targeted with Definiens' companion diagnostics, during the pharma firm's investor day presentation last month, Mohammed Dar, VP of clinical development oncology at MedImmune, noted that as AstraZeneca and MedImmune develop strategies that target multiple immuno-oncology pathways, including the PD-L1 and CTLA-4 pathways, Definiens' technology "is core to our translational strategy … to look at the … microenvironment in these tumors."

Definiens' method is based on using a big data approach to tissue samples. The tissue phenomics approach is underpinned by the firm's Cognition Network technology to generate vast amounts of data, including data about objects found in the tissue and its morphology, "so we understand exactly the structure of the tissue," Heydler said. That information is then correlated with other data sources, such as patient outcomes, allowing Definiens to discover novel biomarkers for stratifying patients.

In immuno-oncology, he said, "it is critical to understand the tumor microenvironment, which is represented in the tissue," and which genomics is limited in its ability to elucidate.

"We think that phenomics is a very, very critical set of information which helps you bridge the gap" that exists in genomic information, Heydler said. "It's all about how this genetic information [translates] into proteins and their structures, which are part of the tissue of a patient.

"And in order to close that gap, we are very, very excited [that] tissue phenomics [is] now becoming much more part of the mainstream and people see that this is a great complement," to genomics. Together, genomics and tissue phenomics can provide a "holistic profile of a patient to make the best diagnostic and obviously the best treatment decision," he said.

The term tissue phenomics, he said, was introduced by Definiens about a year ago, but since then, the research community has come to understand that it is a "critical technology" that is creating "a huge demand for us."

While the deal provides AstraZeneca and MedImmune access to the tissue phenomics technology, it provides Definiens broader and clearer access to patients. Since its founding in 1994 by Gerd Binnig, who won the Nobel Prize in physics in 1986, Definiens has rooted itself in the research market in image analysis and now tissue phenomics. Definiens has about half of that market, Heydler estimated, and the goal is now to expand its footprint in the clinical arena.

The firm, he said, will leverage AstraZeneca and MedImmune's organization from its research to its channels "at the clinical physician point," allowing Definiens to significantly accelerate the delivery of its technology to the patient setting. As the company has no plans to change its pre-acquisition R&D plans, the increased access to clinical data will allow it to accelerate those programs, he added.

Among its planned R&D build-out is an expansion into the digital tissue diagnostics space, and during the summer, Definiens raised €15 million ($20.4 million) in support of those efforts.

He also noted that Definiens will continue to provide services to other clients, as well as to AstraZeneca and MedImmune, similar to how Ventana, part of Roche, operates.

Before the AstraZeneca deal, Definiens had been approached by other suitors about a possible acquisition, Heydler said. For its 20 years, the Munich-based firm — it also has a US subsidiary in Carlsbad, Calif.— had been a venture capital-backed business, and its investors were interested in getting back a return on their investment. He declined to disclose the amount of investments Definiens had received since its founding, but said it is in the "solid two digits" in millions.

In addition to a return on investment, Definiens wanted to make sure that its management team would stay intact as part of any acquisition and that its roadmap for the future would not be scuttled. He, along with the other managers at Definiens, have stayed with the firm post-acquisition and retained their titles, and no layoffs took place.

"At the end of the day, a lot of the value is in the people, and you want to make sure that it works for both sides — you meet the expectations of the investors and you meet the expectations of the management team," Heydler said.

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