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:
Project Number: 2 R44 CA153636 04
NCI SBIR Program Director: Todd Haim
Corvida Medical, an Iowa-based device company, provides innovative technologies that optimize the safe handling of hazardous medications. The Occupational Safety and Health Administration and the National Institute of Occupational Safety and Health confirm that more than 5.5 million workers are exposed annually to chemotherapy and other hazardous pharmaceuticals during drug preparation and delivery, which studies have shown causes cancers, organ failures, reproductive toxicity, and genetic mutations. Corvida is developing a disposable, Closed-System Drug Transfer Device (CSTD) that provides greater safety and significantly improves usability, enabling health care providers to safely deliver the highest quality care to patients. Corvida will use the Bridge funding to expand testing requirements necessary to secure FDA 510(k) clearance of the CSTD product; benchmark studies against a commercial competitor; and productize the new compounding device through development of a beta prototype that meets preliminary specifications, functions with the Corvida CSTD, and completes validation testing for process reliability, accuracy, containment, sterility, and system throughput.
Hyper Tech Research, Inc.
Project Number: 2 R44 CA 144415 05
NCI SBIR Program Director: Deepa Narayanan
Hyper Tech Research, an Ohio-based company, is developing a conduction cooled, liquid helium-free, MRI background magnet for commercial image-guided radiation treatment (IGRT). The cancer treatment system makes available IGRT that delivers gamma radiation in real time to malignant tumors with pinpoint accuracy in spite of organ movement. This system removes the historical dependence on liquid helium, which may suffer worldwide shortages in the next few years. Hyper Tech Research will use the Bridge funding to finalize the modeling and design, complete detailed drawings, and to fabricate the magnet components and superconductor wire. The company will also test all of the system’s coils and will assemble and test the magnet system with their customer base.
Arbor Vita Corporation
Project Number: 9 R44 CA182927 05
NCI SBIR Program Director: Jian Lou
Arbor Vita, a California-based company, is focused on developing products using the proprietary PDZ proteomics platform to improve health care worldwide, with an emphasis on cervical cancer in developing countries. Cervical cancer can be treated if detected early, however due to limited access to screening technologies, this disease remains the second highest cause of cancer-related deaths in young women globally. Arbor Vita will use the Bridge funding to initiate commercialization of its OncoE6TM Cervical Test, which detects levels of E6, a viral protein of the human papillomavirus (HPV). When an HPV infection turns cancerous, E6 levels are elevated. The E6 oncoprotein is the signifier of the most prevalent HPV types found in cervical cancer. This test promises to be simple and specific, and can positively impact countries in need of urgent medical care.
Bexion Pharmaceuticals, Inc.
Project Number: 2 R44 CA136017 04
NCI SBIR Program Director: Todd Haim
Glioblastoma Multiforme is a fast-growing type of malignant brain tumor and the most common brain tumor found in adults. People with this invasive disease have a poor prognosis and generally survive less than a year. Currently, there are no effective treatments for this cancer. Bexion Pharmaceuticals, Inc., a Kentucky-based company, aims to change that. Bexion is using Bridge funding to complete a Phase I clinical trial evaluating BXQ-350, a promising developmental drug that has been shown to effectively target and destroy tumor cells without killing the surrounding healthy cells.
Project Number: 9 R44 CA182927 05
NCI SBIR Program Director: Jian Lou
Diagnostic tools to measure biomarkers can be very expensive, slow, and difficult to use. MagArray, Inc., a California-based company, is using the Bridge funding to optimize its magneto-nanosensor device, which detects multiple biomarkers at ultra-low concentrations. MagArray hopes to advance this highly sensitive, easy-to-use device toward clinical use to aid in the early diagnosis of lung cancer patients, potentially allowing for earlier treatment, which can dramatically improve long-term survival rates.
Project Number: 2 R44 CA138006 05
NCI SBIR Program Director: Andrew Kurtz
Cells with insufficient levels of oxygen—also known as hypoxia—function abnormally, causing underlying diseases like cancer or cardiovascular conditions. Cancer patients with hypoxic tumors have a reduced chance for survival because hypoxia contributes to poor treatment responses and promotes metastasis or the spread of disease. Radiation therapy patients diagnosed with glioblastoma tumors who also suffer from hypoxia will survive for only months. Omniox, Inc., a California-based company, is using the Bridge funding to attract investor-support and advance its research in finding ways to provide oxygen to tumors with an oxygen-carrying protein, OMX-4.80. This protein has the potential to vastly improve radiotherapy treatment responses for patients with hypoxic glioblastoma.
Project Number: 2 R44 CA128163 05
NCI SBIR Program Director: Gregory Evans
Current methods for biopsies of the esophagus are limited and do not always detect early-stage esophageal cancer lesions. Oncoscope, Inc., a North Carolina-based company, created the Panocyte system to use on patients with Barrett’s esophagus, a condition that increases a patient’s risk of developing esophageal adenocarcinoma. Oncoscope is using Bridge funding to develop the system, which provides a highly sensitive tool that delivers quantitative measurements of cellular characteristics correlated to cancer progression. The system will also allow clinicians to examine a large portion of at-risk tissue and detect esophageal cancer in its pre-cancer stages, allowing for a much more treatable diagnosis.
Wilson Wolf Manufacturing Corporation
Project Number: 9 R44 CA165607 04
NCI SBIR Program Director: Patricia Weber
Wilson Wolf Manufacturing Corporation, a Minnesota-based company, is using Bridge funding to create an effective treatment for metastatic melanoma. Currently, adoptive immunotherapy is a complicated and limiting process, requiring the growth of immune system cells in vitro and infusing them into the patient for treatment. Wilson Wolf has simplified the process using the “G-Rex” approach to Tumor Infiltrating Lymphocyte (TIL) therapy, by allowing the cells to live in an environment in which they have access to oxygen and nutrients without the need of extra equipment. The cells will produce faster, there will be a lessened need for labor and certain devices, and the treatment will be much more cost effective than current adoptive immunotherapy devices.
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.
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.
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
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.
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.
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.
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 that 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