NCI awards 20/20 GeneSystems $3 million to develop tests for targeted cancer therapies

20/20 GeneSystems, Inc. ("20/20" ) announced today at the AdvaMed MedTech Conference in Washington, D.C. that the company has been awarded nearly $3 million in grants from the National Cancer Institute's (NCI) Small Business Innovative Research (SBIR) Program to develop tests to help oncologists predict the effectiveness of targeted cancer therapies. Over 20 targeted therapies have been approved over the last 10 years but they typically benefit only a subset of patients to whom they are administered. This creates missed opportunities for individual patients who might otherwise have been helped with more effective drugs while wasting hundreds of millions of dollars in unnecessary spending.

“Heretofore, the complex web of signaling pathways within cancer cells made predicting drug efficacy an arduous task. Now, with technologies like L-IHC that can simultaneously assess several signaling pathways at once, that task has become more manageable”

The larger of the two awards is a $2.75 million SBIR Phase IIB "Bridge Award" directed at developing a companion diagnostic--called PredicTOR™--that predicts tumor response to drugs that target, or are impacted by activation of the mTOR pathway. This includes the drugs TORISEL® (Pfizer) and AFINITOR® (Novartis) which have been approved for the treatment of kidney cancer. The SBIR Bridge program requires matching funds from outside investors and non-federal organizations. These matching funds are being provided by several private investors as well as $200,000 from the Maryland Biotechnology Center (MBC). "We congratulate 20/20 on winning the Bridge Award for their groundbreaking proposal in breast and kidney cancer diagnostics. The MBC is proud to participate in the match for this award since it demonstrates the power of leveraging funds from both public and private sources. We look forward to the outcome of these studies which can potentially impact so many affected by cancer," said MBC director Judy Britz, Ph.D., herself a veteran of several leading diagnostics companies.

In addition to the Bridge Award, the company also won a $200,000 Phase I SBIR contract directed at the development of a test to predict kidney tumor response to drugs that target the VEGF pathway such as SUTENT® (Pfizer).

Both tests will utilize 20/20's patented technology--known as "Layered- Immunohistochemistry (L-IHC)" -- which allows for the simultaneous detection of multiple biomarkers in a single tissue section while preserving its morphology and eliminating several limitations associated with the few current multiplex histology techniques. "Heretofore, the complex web of signaling pathways within cancer cells made predicting drug efficacy an arduous task. Now, with technologies like L-IHC that can simultaneously assess several signaling pathways at once, that task has become more manageable," said Michael Lebowitz, Ph.D., 20/20's R&D Director. "We greatly appreciate the support from the NCI SBIR program," he added. Last month 20/20 began offering the technology to industry and academic researchers under service contracts.

The technology was developed in collaboration with teams from the Laboratory of Pathology of the U.S. National Cancer Institute (NCI) including the laboratories of Stephen Hewitt and Michael Buck. The NIH Small Business Innovative Research (SBIR) and NIST Advanced Technology Program programs have supported development of and improvements to L-IHC.