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SBIR Phase IIB Bridge Award

The National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) Phase IIB Bridge Award is designed to support the next stage of development for promising NIH-supported SBIR Phase II projects in the areas of cancer therapies, diagnostics, and cancer imaging technologies.

Continue reading to learn about all current Bridge Awardees and the cancer technologies they are developing:

FY2010 Awardees:

NCI announced four new Phase IIB Bridge Awardees in FY2010.

  • 20/20 GeneSystems, a Maryland-based company focused on the development and commercialization of innovative, proprietary diagnostics tests that aid in the fight against cancer. This company has developed, with the support of the NCI's SBIR program, an improved approach to immunohistochemistry ("Layered-IHC", also referred to as Layered Expression Scanning) that permits 10 or more biomarkers to be measured simultaneously from a single section of biopsied tissue while maintaining morphology. 20/20 GeneSystems will utilize the bridge funding to develop an mTOR companion diagnostic, PredicTOR™, based on this proprietary IHC technology. The bridge funding will also be used to clinically validate the test in kidney, breast, and lung cancer.
  • Advanced Cell Diagnostics, Inc., a California-based company focused on technology to assess molecular profiles at the single-cell level. Advanced Cell Diagnostics will utilize the funding for the development of an automated system (CTCscope) for the detection, enumeration, and molecular analysis of circulating tumor cells (CTC) in cancer patients. The unique detection methodology (RNAscope) is based on in situ RNA detection, which also provides molecular phenotyping. This approach has distinct advantages over current methods for detection of CTC that use protein markers such as human epithelial cell adhesion molecule. Like all CTC products, this product has the potential to reduce or avoid invasive, risky biopsies.
  • AmberGen, Inc., a Massachusetts-based company focused on developing a new generation of diagnostic tests. AmberGen will utilize the Bridge funding for the further refinement and clinical evaluation of a gene expression-based prognostic assay that monitors the recurrence and response to treatment of colorectal cancer (CRC), a significant public health issue. The assay, initially developed and evaluated during AmberGen’s SBIR Phase II award, requires only 4 genes to predict CRC recurrence with over 95% accuracy and only 4 genes to predict response to 5-fluorouracil therapy with over 91% accuracy. The commercialization potential for this assay is substantial, and could follow a similar path as other gene expression-based assays for breast cancer. This project includes participation by the Ontario Institute of Cancer Research (OICR), Dana Farber Cancer Institute and the UCSD Morris Cancer Center.
  • Praevium Research, Inc., a California-based company focused on the development and commercialization of high functionality, radically miniaturized opto-electronic devices. Praevium will utilize the funding from the Bridge award for the development of an ultra-broad tuning range, ultrahigh scan rate, swept laser source imaging engine that will enable the next generation of Optical Coherence Tomography/ Optical Coherence Microscopy (OCT/OCM) systems. OCT and OCM have powerful advantages as a cancer imaging modality because they provide information on tissue pathology in real time, without the need to excise and process specimens as in conventional excisional biopsy and histopathology. This work involves collaboration between Praevium Research, their commercial partner, Thorlabs, and the OCT group at the Massachusetts Institute of Technology.

Previous Bridge Awardees:

The inaugural companies to receive the Phase IIB Bridge Awards are:

  • Altor BioScience Corporation, a Florida-based company focused on the discovery and development of high-value, targeted immunotherapeutic agents for the treatment of cancer, viral infection and inflammatory diseases. Altor BioScience will utilize the funding from the award for the development of a bifunctional T cell receptor-based immunotherapeutic directed against multiple types of cancer. These innovative molecules promise to enhance the efficacy and reduce the toxicity of existing drugs by targeting a wide range of tumor and viral antigens.
  • Gamma Medica-Ideas, Inc., a California-based business focused on designing, building, selling and servicing pre-clinical and clinical imaging systems. Gamma Medica-Ideas will utilize the funding for the development of a novel Molecular Breast Imaging (MBI) technique to guide clinical management of breast cancer. The MBI-based system hopes to revolutionize the way breast cancer is diagnosed and treated.
  • Guided Therapeutics, Inc., a Georgia-based company focused on a rapid and painless test for early detection of disease that leads to cervical cancer. Guided Therapeutics will utilize the funding from the award for the development of the LightTouch™, a class III device and will require PreMarket Approval (PMA) by the FDA. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. The technology is designed to quickly eliminate false positive Pap and HPV results and discover cervical disease missed by existing tests.
  • Koning Corporation, a New York-based medical imaging company focused on the development of advanced imaging systems that combine the advantages of Digital X-ray and Computed Tomography called Cone Beam CT (CBCT). Koning will utilize the funding from the award for the development of a CBCT scanner. CBCT scanners can be tailored to specific rather than general applications and have the potential to be faster, smaller and less expensive to own and operate compared to current technology. There is hope that CBCT may offer improved detection and diagnosis of breast cancer.
  • Lpath Therapeutics, Inc., a San Diego-based company focused on lipidomics-based therapeutics. Lpath will utilize the funding from the award, along with matching third-party partner funds, to advance its lead product candidate ASONEP™, a potentially first-in-class anti-cancer agent which binds to and inhibits the bioactive lipid Sphingosine-1-Phosphate (S1P), a multifunctional mediator that can become dysfunctional and contribute directly to the pathophysiology of cancer.
  • OptoSonics, a North Carolina-based company focused on developing molecular imaging instrumentation used in the fields of molecular biology, oncology, drug discovery, diagnostics, and therapeutic medicine. OptoSonics will utilize this funding, along with matching third-party partner funds, to advance a photoacoustic computed-tomography (PCT) scanner for conducting preclinical molecular imaging. By utilizing high throughput and excellent image resolution, the PCT scanner has the potential to accelerate the development of preclinical cancer drug development while lowering associated costs.

Click here to learn more about the SBIR Phase IIB Bridge Awards