Nuvera Biosciences announces that it has entered into a licensing agreement with Veridex LLC to commercialize its assays for predicting patient response to tamoxifen therapy and taxane-containing chemotherapy in breast cancer.

The assays, presented at several international conferences in 2008, have been developed by Nuvera and the University of Texas M.D . Anderson Cancer Center.

Predictive biomarkers that help determine response to therapy have advanced scientifically, but the decision on which specific therapy is best for each individual patient continues to pose a challenge. Nuvera Biosciences and M.D. Anderson have addressed this critical issue with the development of two multi-gene assays that could help determine the outcome of tamoxifen as hormonal therapy and of taxane-based chemotherapy.

“We are excited to be working closely with the Veridex team to create significant momentum in regulatory development and market introduction of these important cancer tests,” said Dr. Nandan Padukone, President and CEO of Nuvera. “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,” he added. The Nuvera test portfolio will also be capable of reporting status of standard tumor markers such as ER and Her2.

As part of the license agreement, Nuvera will receive an upfront payment and will earn payments for performance milestones over the next several years from Veridex as the products move through commercialization and revenue-based milestones. Nuvera will continue to support test validation by using its expertise in diagnostics and bioinformatics, and by leveraging its partnership with M.D. Anderson and other leading cancer centers. Veridex will complete clinical studies and market development for the test, and commercialize the test through its marketing and sales operations. Nuvera will also receive royalty payments for product sales generated by Veridex worldwide.

Assays for tamoxifen and taxane sensitivity

Nuvera’s assay for predicting response to tamoxifen was developed from genes that are co-expressed with the estrogen receptor (ER) gene. This assay was evaluated for predicting relapse-free survival in patients with ER-positive tumors treated with tamoxifen as the only adjuvant therapy (ASCO BCS, 2007).

Independent validation study showed that high assay scorers (therapy responders) had significantly higher distant relapse-free survival (DRFS) compared to low scorers (non-responders). On the other hand, a separate evaluation of a cohort of patients who did not receive any therapy after surgery showed no benefit in DRFS between high and low scorers demonstrating that the assay is specific of therapy outcome rather than of a prognostic effect.

Nuvera has developed a predictor for taxane-containing chemotherapy response based on prospective neoadjuvant trials at M.D. Anderson (Hess et al, JCO, 2006; Hatzis et al, ASCO, 2008). The improved assay, presented at ASCO 2008, was developed with needle biopsies of HER2-normal, stage I-III breast cancer patients who received taxane-chemotherapy. Predictor cross-validation showed that patients with excellent response had significantly better relapse-free survival. More significantly, the predictor showed that, in a subset of patients with triple-negative breast tumors (n=94), which are difficult to treat, about half of the patients would have an excellent outcome with less than 10% relapse 5 years after taxane-therapy, whereas the other half would be resistant to taxane-therapy and have a 60% probability of relapse.

“With these assays now focused firmly on market development, we will accelerate the development of our pipeline products for other cancer therapies,” said Dr. Padukone. Nuvera continues to actively collaborate with an established clinical network to study tumor response to standard and targeted drug therapy regimens in order to develop a diagnostic portfolio across a range of cancers.