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Picture of pre- and post-therapy tumor cells that are being treated with NovaRx
Figure 1 and 2. Pre-therapy (top) and post-therapy (bottom) show how patented NovaRx vaccine technology reduces tumor cells in lung cancer. Nemunaitis, John, Dillman, Robert O., Schwarzenberger, Paul O., Senzer, Neil, Cunningham, Casey, Cutler, Jodi, Tong, Alex, Kumar, Padmasini, Pappen, Beena, Hamilton, Cody, DeVol, Edward, Maples, Phillip B., Liu, Lily, Chamberlin, Terry, Shawler, Daniel L., Fakhrai, Habib. Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in Non-Small-Cell Lung Cancer. J Clin Oncol. 2006 24: 4721-4730. Image posted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.

Using SBIR funding from 2002 to the present, San Diego-based NovaRx Corp. was able to successfully transition its vaccine platform technology from years of early research to clinical trials that have shown promising results. NovaRx is developing several vaccines using this platform technology, including Lucanix™, a vaccine for non-small-cell lung cancer that will soon begin recruiting for phase III clinical trials. Lucanix™ has received fast-track status from the FDA to accelerate the speed by which this promising vaccine reaches patients. Most recently, NovaRx received a three-year SBIR grant in 2007 to extend its cancer vaccine therapy research to glioma, a type of tumor in the brain. This funding will allow NovaRx to move glioma vaccine research forward to phase III clinical trials.

“We would not have been able to start our research on other tumor sites without SBIR funding and the credibility that SBIR involvement brings to venture capital investors,” explains Habib Fakhrai, Ph.D., NovaRx co-founder and president.

Early research focused on increasing the immunogenicity (ability to produce an immune response) of the vaccine itself and did not address the tumor cell’s protective mechanism of using TGF-β (Transforming Growth Factor) to impair the immune system and ensure its survival. NovaRx researchers were the first to recognize the value of blocking TGF-β, the primary molecule that many tumors secrete to avoid detection by the immune system in order to proliferate. To block the TGF-β secreted by the tumor, NovaRx modified the antisense gene of the tumor cells used in the vaccine and patented this innovative platform for vaccine therapy. With the company’s innovation, tumor cell vaccines became more effective in penetrating the tumor and allowing the immune system’s effector cells (T-cells, B-cells, antigen-presenting cells) to destroy the tumor.

Advancing Cancer Research

Phase II clinical trial results for advanced stage (stage IIIB and stage IV) non-small-cell lung cancer showed a dramatic increase in two-year survival rates and median survival time for those receiving a high-dose of the vaccine (47 percent; 581 days, respectively), compared to current approved therapies (less than 20 percent; 240 days). These promising results also have broad implications for other tumor types because many different tumors produce TGF-β as the primary molecule to suppress the immune system. NovaRx plans to explore this platform technology with additional tumor sites.

“The National Cancer Institute was very supportive throughout the funding process,” said Fakhrai. “This funding from the National Cancer Institute required a peer review process for our application, which gives credibility to the research results. Because of this credibility, we are able to continue to secure matching funds from outside investors and further our research at a faster rate.”

See the NovaRx website for more information about NovaRx.

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Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Cancer Institute (NCI), the NCI's Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs, or any other portion of the U.S. Government.