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J&J Building Portfolio for CTC and Companion Diagnostics

By Tony Fong

NEW YORK (GenomeWeb News) – With little fanfare, Johnson & Johnson is building out its capabilities in the molecular diagnostics space with a focus on circulating tumor cells and companion diagnostics development.

In recent interviews with GenomeWeb Daily News, officials from several J&J businesses outlined a strategy focused on continuing to build out the firm's CellSearch technology as well as the development of a next-generation CTC technology in collaboration with Massachusetts General Hospital.

Meanwhile, a new center of excellence focused on companion diagnostics is leveraging technology developed internally and by outside diagnostic firms to capitalize on growing interest in such tools among drug firms.

According to Werner Verbiest, head of the Companion Diagnostics Center of Excellence for the pharma group at J&J, "we really see molecular diagnostics as critical tools and critical enablers for personalized medicine," but clinicians need greater access to the technology.

"A lot of those technologies have been made at the hands of … exotic and little labs, so we're looking at investments in companies and partnerships with companies to bring it closer to the clinic," said Verbiest, who is also the CEO of Virco, which J&J purchased in 2002. "We use different projects as drivers of those investments, so molecular diagnostics for us is fairly important."

J&J, he added, is evaluating how to approach the MDx market, and while some competitors have taken to making big-splash acquisitions, it may not be the best strategy for J&J in bringing companion diagnostics to the market.

"You go for targeted investments or targeted collaborations, and you don't need to own everything to make a difference," Verbiest said.

J&J is divided into three business segments — consumer sales, pharmaceutical, and medical devices and diagnostics. In 2010, the medical devices and diagnostics segment brought in sales of $24.6 billion, a 4 percent increase from 2009, which included a 5 percent increase year over year in revenues for Ortho-Clinical Diagnostics to $2.1 billion.

In a research report last month, Goldman Sachs analyst Isaac Ro said that in a meeting with J&J management, an official was "bullish on the potential for molecular diagnostics as a high-growth category," and the firm's strategy focused on three areas: organic growth through investments in its Veridex business and Swiss molecular diagnostics firm Biocartis; licensing opportunities; and acquisitions.

J&J's interest in the molecular diagnostics space is evidenced by partnerships and investments that the New Brunswick, NJ-based firm has done in recent months. J&J Development Corp., the venture capital subsidiary of J&J, was part of an investor group that earlier this month participated in a $13 million round in protein biomarker company Astute Medical.

Last year, J&J was a participant in a Series B round by Biocartis that raised €30 million ($42.7 million).

In January, Janssen Pharmaceutica, part of J&J's Janssen Pharmaceutical division, announced it would develop assays on the Biocartis platform. In the same month, J&J participated in a $9 million Series C round by direct-to-consumer genomics firm 23andMe.

This year also started off with Veridex, a J&J business which develops in vitro oncology diagnostics, announcing a collaboration with Mass General aimed at technology for capturing, counting, and characterizing tumor cells from patient blood samples.

The five-year deal, the financial terms of which were not disclosed, is intended to create a next-generation platform for CTC detection and characterization.

Extending CTC to Personalized Medicine

In 2004, Veridex launched the first commercially available CTC test with the CellSearch platform. The test is now cleared by the US Food and Drug Administration for metastatic breast, prostate, and colorectal cancers. In addition, the firm is about to launch a test for melanoma based on the CellSearch technology, with a test for multiple myeloma to follow, said Bob McCormack, head of technology and strategy for Veridex.

The company is now in the midst of extending CellSearch's capabilities to, for example, image the cells and characterize them at the chromosomal, DNA, and protein levels. The platform now has the ability to characterize CTCs at the protein and chromosomal level, said McCormack.

Fluorescent in situ hybridization capabilities have also been developed for the technology "and we have that in the field now as a trial," he added, and RNA and DNA characterization can be achieved on CellSearch manually but not as an automated process.

That's where its deal with Mass General comes in. The partnership is focused on developing a benchtop platform for studies of the biology of rare cells at the protein, RNA, and DNA levels. The platform would be used by oncologists as a diagnostic tool for personalized care and by researchers "to accelerate and improve the process of drug discovery and development," Veridex and Mass General said in January.

Nicholas Dracopoli, vice president of biomarkers for Ortho Biotech Oncology Research & Development, told GWDN last week that a prototype device is in development. Early stage testing of the platform has begun and the testing of clinical samples are anticipated to take place during the next two years.

The platform is being designed around the functional analysis of CTCs "to extract actionable, clinical information from the cells," Dracopoli said. While the primary application of CellSearch has been for the enumeration of tumor cells of epithelial origin circulating in the patient's blood, the Veridex-Mass General system focuses on tumor cell characterization.

"So we want to set specifications around being able to isolate tumor cells with greater sensitivity, [and] to maximize the sensitivity in terms of the number of cells we can isolate from the blood," Dracopoli said.

"The critical point that we realized is that just creating another platform that isolates the cells is insufficient," Dracopoli said. What is needed, he said, is a system "that works within the context of a regulatory approved environment, that is able to deliver actionable, clinical information in real time, that will be able to inform oncologists as they treat patients, both to select therapy initially, and then to monitor that therapy for acquired resistance during treatment."

The goal ultimately is to develop a platform that will be used in house and by other companies developing companion diagnostics along with targeted therapies.

Dracopoli added that while the platform will be an immunoassay, the collaboration includes use of next-generation sequencing technology to sequence tumor cells "as a surrogate for an invasive biopsy of the tumor cells," in order to search for activating mutations in pathways.

By doing so, a better understanding can be gained of the critical cancer pathways that may be activated by genetic factors. Such mutations can then also be monitored for changes over time, Dracopoli noted, "and then you can adjust the targeted therapies to inhibit particular tyrosine kinases."

He emphasized, however, that the work between J&J and Mass General is not directed at inventing a new sequencing methodology. The plan is to partner with sequencing companies to develop integrated ways of progressing from cells captured by J&J and Mass General to DNA sequencing analysis, and then a computational biology read-out.

Traditional Sanger sequencing will be used for the same purpose, said Dracopoli, who did not rule out the possibility that a sequencing-based test could result from the collaboration.

"It would vary according to the individual biomarker," he said. "In some cases, it would be sequencing, in other cases, it would be a protein-based test. The difficulty we have when we think about companion diagnostics is there is no one test that is going to give us all the answers."

As a result, "many, many" assays may emerge from the collaboration that in addition to being DNA or protein-based, may be epigenetics- or RNA-based, Dracopoli said.

Diagnosing Drug Safety and Effectiveness

In addition to work being conducted at its individual businesses, J&J last year created its Companion Diagnostics Center of Excellence (COE) within its pharma group in order to centralize some of the development work, forge partnerships with outside parties, and explore commercialization opportunities.

"The vision of Johnson & Johnson in pharma is to have a patient-focused mindset and to move away from a one-size-fits-all [model] to more targeted and personalized therapy," Verbiest, the center's head, told GWDN. "You see now more and more therapeutic areas requiring … a companion diagnostic. So from that perspective, we've brought together a team that supports all the therapeutic areas for companion diagnostics."

While companion diagnostics development is still in its early stages, it's a market that is anticipated to grow in the coming years. In a blog post in January, Prashant Dilwali, a senior analyst at life sciences consulting firm Scientia Advisors, wrote that companion diagnostics are appealing to pharma as a business and as partnership opportunities because they can provide potential revenue streams as well as "knowledge capital" to better match the most appropriate treatment with a patient.

"Better targeting can lead to more efficacious and safer therapies — potentially bringing back pipeline products previously thought to be ineffective," Dilwali said. "More important, diagnostics are viewed as viable businesses because they offer opportunities for portfolio diversification, thus lessening pharma's risk without radically changing their core businesses."

J&J's rationale for creating the COE, Verbiest said, was "to build a cross-enterprise integrated capability and knowledge center to support the discovery, and the development, and the commercialization of companion diagnostics."

Eventually, the COE, which operates out of Raritan, NJ, and Beerse, Belgium, may partner with other drug manufacturers, but for now, collaborators include Quest Diagnostics and Laboratory Corporation of America, Verbiest said. Other partners include Abbott, Roche, and Quintiles. It also is working with molecular diagnostic firms, though Verbiest declined to identify them.

While the center is in the midst of several development projects, it has not yet brought any tests to market, and Verbiest said it may be two years before its first product is launched. The first test is being co-developed with a partner, which he declined to identify. He also declined to say what indication the test targets or to provide details about other tests in development

Though the center is a shared resource for all of J&J's businesses, each business may also conduct their own companion diagnostic development. Depending on the success of its development work and how the market evolves, "time will tell whether some of those companion diagnostics can be some interesting business opportunities in themselves," Verbiest said.

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