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GeneCentric Licenses UNC IP for Lung Cancer Subtyping Dx, Signature Linked to anti-VEGF Rx Response

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Originally published August 31.

Newly launched molecular diagnostics firm GeneCentric this week secured exclusive licenses for a lung cancer subtyping platform and a 13-gene VEGF signature from the University of North Carolina, Chapel Hill, that will enable the company to advance its first cancer diagnostic and ink partnerships with pharma.

In 2011, Charles Perou and David Neil Hayes, UNC cancer researchers who discovered molecular signatures associated with subtypes of lung cancer, founded GeneCentric with $250,000 in Series 1 funding.

The Lung Subtyping Platform, which will likely be GeneCentric's first commercial clinical test, differentiates squamous and non-squamous subtypes of non-small cell lung cancer. Squamous cell carcinoma affects the cells in the lining of the lungs, while other subtypes of NSCLC impact large cells or cells in the tiny air sacs in the lung.

GeneCentric's subtyping test has the potential to help oncologists better characterize their patients' disease and prescribe the targeted treatment they are more likely to benefit from and less likely to experience adverse events with. According to Myla Lai-Goldman, CEO of GeneCentric, the company plans to eventually update the Lung Subtyping Platform so it can further discern whether patients have small cell lung cancer, carcinoid disease, or different types of adenocarcinoma.

GeneCentric plans to market the test as tool that oncologists and pathologists can use in addition to histopathological data to diagnose lung cancer. "All clinicians and pathologists who care for lung cancer patients will be interested in the assay," Lai-Goldman said. She noted that GeneCentric hasn't established a price for the subtyping test.

The company is launching the Lung Subtyping Platform as a lab-developed test based on a number of published studies that show the test's ability to gauge NSCLC subtypes. For example, in a paper published in 2006 in the Journal of Clinical Oncology, researchers led by UNC's Hayes described how they selected a subset of prognostic genes by analyzing lung cancer tissue samples from three different cohorts with DNA microarray assays.

"Tumor subtypes were distinguishable by many hundreds of genes, and lists generated in one cohort were predictive of tumor subtypes in the two other cohorts," the researchers reported in the paper. "Tumor subtypes correlated with clinically relevant covariates, including stage-specific survival and metastatic pattern."

The other exclusive license that GeneCentric has garnered from UNC is for a 13-gene VEGF signature, dubbed the "Hypoxia Signature," which in previous studies has been shown to characterize poor outcomes and distant metastases in breast, lung, and brain cancer patients. Additionally, exploratory analyses by researchers led by Scripps Research Institute's Scooter Willis has shown that the signature may predict which breast cancer patients could live longer after treatment with Genentech's anti-angiogenic drug Avastin (bevacizumab).

"We envision the 13-gene assay to have significant value as a companion diagnostic for pharma. So, for now, we do not have plans to offer it as a clinical diagnostic," Lai-Goldman told PGx Reporter. "As we complete additional validation studies … our commercialization plans may change."

In the Scripps exploratory study, presented at the American Society of Clinical Oncology's annual meeting this year, Willis and colleagues analyzed 122 formalin-fixed, paraffin-embedded tissue samples from breast cancer patients enrolled in the E2100 trial comparing treatment with Avastin plus paclitaxel to paclitaxel alone. The researchers found that progression-free survival was the same in both treatment arms, despite whether patients had low or high VEGF signatures. However, patients with the high VEGF signature in both treatments arms experienced an overall survival benefit compared to those with a low VEGF signature.

"This signature, which suggests that the response to hypoxia includes the ability to promote new blood and lymphatic vessel formation, shows great potential as a predictive biomarker of those patients to whom bevacizumab would convey an OS advantage benefit," Willis et al. concluded in the abstract presented at the ASCO meeting. "We note with great caution that this exploratory analysis of trial subset is underpowered, hence, this compact VEGF signature is being pursued in other bevacizumab trial sets."

Last year, the US Food and Drug Administration revoked Avastin's breast cancer indication "after concluding that the drug has not been shown to be safe and effective for that use." The agency has encouraged Roche subsidiary Genentech to continue to explore biomarkers that might identify which breast cancer patients respond to the drug (PGx Reporter 11/30/2011).

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