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Nuvera, J&J's Veridex Ink Deal to Develop, Market Breast Cancer Drug Response Dx

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Nuvera Biosciences has penned a licensing agreement with Veridex to develop and commercialize assays to gauge treatment response to tamoxifen and taxane-containing chemotherapies, the companies said this week.

Nuvera announced the deal nearly a year after it presented data at a scientific conference describing multiple gene indexes that could be used to help predict response to breast cancer treatments.

Under the terms of the agreement, Nuvera will run clinical trials to validate the assays, which "are in the same market" as Genomic Health's OncotypeDX, according to Nuvera CEO Nandan Padukone. In turn, Veridex, a cancer diagnostics company owned by Johnson & Johnson, will clinically validate, launch, and market the tests.

Padukone told Pharmacogenomics Reporter following the American Society of Clinical Oncology's annual meeting last June that the company was developing NuvoSelect eRx, a 200-gene index for breast cancer patients who experienced a positive clinical outcome from endocrine therapy, and NuvoSelect cRx, a 207-gene predictor of taxane-based chemotherapy response [see PGx Reporter 06-11-2008].

The assays, which Nuvera now intends to commercialize, are being developed out of research the company conducted with the University of Texas MD Anderson Cancer Center. The tests will run on Affymetrix's microarray platform. The company has not yet published the specific genes the tests will interrogate.

Nuvera's tamoxifen response assay is designed to detect genes co-expressed with the estrogen receptor gene. According to the company, an independent validation study showed that patients the test determined to be responders to tamoxifen had higher distant relapse-free survival compared to non-responders.

Meantime, the company has published clinical data on the predictor for response to taxane-based chemotherapies has shown that patients predicted to be responders had improved relapse-free survival.

Particularly, in a subset of patients with triple-negative breast tumors, researchers concluded that approximately half of the patients would have an excellent outcome with less than 10 percent relapse five years following taxane-therapy. By comparison, the other half would be resistant to taxane therapy and have a 60 percent probability of relapse.

The companies did not reveal certain details about the impending diagnostics, such as whether they will fall into the in vitro diagnostic multivariate index assay-category, if the companies plan to submit the tests to the US Food and Drug Administration, or how the tests would be marketed.

"We fully expect our focus this coming year to be on completing clinical validation of the tests," Padukone told Pharmacogenomics Reporter. He added that the partners had not yet worked out more detailed timelines for developing and marketing the assays.

The deal could eventually merge both tests with other Veridex diagnostics into a single assay, according to Padukone.

Currently Veridex markets the GeneSearch Breast Lymph Node Assay, which helps inform treatment decisions by detecting cancer metastases, and the CellSearch Circulating Tumor Cell Test, a blood test that captures and assesses CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer.

"We believe the uniqueness of our tests is not just their therapy-directed focus but that they can potentially be combined with Veridex tests into a single test platform that could enable important, effective decisions from a single tumor sample," Padukone said.

Under the license agreement, Nuvera will receive an undisclosed upfront payment as well as additional payments for performance milestones over the next several years from Veridex as the tests enter the marketplace. Nuvera will also receive undisclosed royalty payments for worldwide product sales.

Competitive Space

When the assays are launched, they will enter a breast cancer testing market that already includes products made by Genomic Health and Agendia. These companies are seeing adoption of their products after multiple years of conducting validation studies, pursuing inclusion of their products in clinical guidelines, and educating payors.

Still, in an effort to differentiate Nuvera's products from those tests, Padukone noted that Nuvera's "assays have been developed with patients who received a specific standard-of-care therapy such as tamoxifen and taxane chemotherapy, and have been shown to have the ability to predict response to those therapies," unlike OncotypeDX, which provides "a broad risk of recurrence [and] a general therapy benefit."

OncotypeDX is marketed as a test that gauges the likelihood of disease recurrence for women previously diagnosed with and treated for breast cancer. The test has also shown to effectively predict which patients will likely benefit from tamoxifen.

At the San Antonio Breast Cancer Symposium last year, Agendia presented new clinical trial data for its MammaPrint breast cancer recurrence test, which it said supports expanding the assay’s indication to include predicting chemotherapy response.

In a note to investors last month, investment bank Thomas Weisel Partners noted that due to Genomic Health's IP protection around its 21-gene panel assay and its strong reimbursement position due to payor and patient education efforts, competitors will be chasing the company's dominance in the market (see related article, in this issue).

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