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Axela Partners with OvaGene to Commercialize Ovarian Cancer PGx Test

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Axela and OvaGene Oncology this week announced a partnership that will see OvaGene's gene signatures related to ovarian cancer treatment become available on Axela's Ziplex array platform.

Paul Smith, chief operating officer at Axela, told BioArray News that the firms intend to make the test available as a service via OvaGene's Irvine, Calif.-based CLIA-compliant laboratory. He said that OvaGene's test will evaluate genes associated with drug response to commonly used chemotherapy and that OvaGene is currently validating the assay. Once that study is complete the firms will have a "more definitive timeline" of when the test will be available clinically, Smith said.

Toronto-based Axela also has the option to "pursue other regulatory approvals and commercialize the assay," according to Smith, meaning that the firm could submit the test to the US Food and Drug Administration and sell it as a kit for use on the Ziplex system. He declined to provide additional details on such plans, though.

Ovarian cancer is one of OvaGene's indications of interest. The company is developing gene-based signatures and assays to personalize the treatment of uterine and cervical cancers as well.

Smith said that Axela and OvaGene will evaluate these other signatures in the future to "identify additional assays that might make sense from both a technology and market perspective."

In addition to those signatures, OvaGene offers a number of research assays focused on endometrial cancers. It relies on a number of technology platforms for its research, including gene expression arrays, comparative genomic hybridization arrays, and quantitative PCR.

Axela's Ziplex is a low-density microarray platform that is designed for customized applications in RNA and protein research. The company's TipChip consumables consist of 6.5 mm2 chips mounted on a plastic tube, each of which is made of porous silicon with more than 200,000 microchannels.

Within each microchannel is a three-dimensional matrix where molecular interactions occur as target solutions are repeatedly passed back and forth through the channels. The company claims this approach facilitates the interaction between target molecules and immobilized probes.

OvaGene chairman Frank Kiesner said in a statement that the firm's use of Axela's technology could "yield significant benefits" for patients and physicians.

Kiesner claimed that more than 20 different drugs are currently used to treat ovarian cancer in the US, and that each shows a "low" response rate of between 12 percent and 15 percent. He said that the availability of OvaGene's test will provide physicians with an "opportunity to improve these response rates by personalizing drug selection," though he didn't elaborate on the extent to which those rates could be improved.

Smith credited his company's automated assay and the "flexibility to include additional pathway information and controls" for the deal, and said the Ziplex is "particularly well-suited for the application."

According to Smith, the two parties were connected by a "mutual interest in seeing these types of tests made available to a wider segment of the population." He said that Axela and OvaGene also have a number of academic collaborators in common.

Smith said that a publication describing OvaGene's ovarian cancer assay is being prepared, but he declined to further discuss the gene signature. He noted that the signature has not been implemented on another platform to date.

A number of other firms are developing array-based tests for ovarian cancer. Craigavon, UK-based Almac Diagnostics has a test in development that could be used to select treatments for ovarian cancer patients, while Sunnyvale, Calif.-based Arrayit is working on an early-stage ovarian cancer detection assay called OvaDx (BAN 6/7/2011, BAN 12/20/2011).

Complementary Assays

Michael Treble, executive chairman of Axela, in a statement this week called the deal with OvaGene "another important addition to Axela's pipeline of diagnostic content." He said that OvaGene's signature "complements [Axela's] other development programs," including its Breast Cancer Risk of Recurrence Assay.

That assay has been years in the making. Axela gained the Ziplex platform through its acquisition of Wellesley, Mass.-based Xceed Molecular in 2010 (BAN 7/27/2010). At the time of the buy, Xceed Molecular was developing a gene expression assay on the Ziplex for predicting breast cancer recurrence, with the hope of submitting the test to the FDA in 2011.

While the integration of the firms cost Axela time, the company said last month that it was working with two hospitals, Mount Sinai Services in Toronto and Brigham and Women's Hospital in Boston, to validate the Risk of Recurrence Assay. Axela said that as part of the collaboration, the two hospitals will conduct a blinded trial of breast cancer patients to assess the ability of the assay to predict the five-year risk of distant metastasis and the ability of cancer center laboratories to use the test locally.

The study will provide information on the risk of recurrence, ER/PR/HER2 status, and molecular subtype, as well as information about the activation levels of the proliferation and immune response pathways on formalin-fixed, paraffin-embedded tumor samples analyzed with Axela's Ziplex platform. The firm said at the time that the results of the breast cancer study should be available this fall and will be used to characterize the assay's performance in the context of other clinical factors being used to manage the treatment of breast cancer patients.

Smith said this week that sample sourcing for the breast cancer study is complete and that tissue analysis has begun at the two partner sites. "It is expected that this stage of the trial and preliminary data analysis will be completed by the end of October," he said.

Smith added that Axela is currently in "partnering discussions" that will "determine the choice of regulatory path and timing of submission" of the Risk of Recurrence Assay.

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