Small Business Programs: Recovery Act Investment Report
Public Health Burden of Cancer
Cancer is the second leading cause of death in the United States after heart disease. In 2009, it is estimated that nearly 1.5 million new cases of invasive cancer will be diagnosed in this country and more than 560,000 people will die of the disease.
SBIR and STTR are government set-aside programs for domestic small businesses to engage in research and development (R&D) projects that have the potential for commercialization and public benefit. They foster R&D in a variety of cancer-related areas, including anticancer agents, biomarkers, informatics, medical devices, nanotechnology, proteomics, pharmacodynamics, and many other technologies and programs designed to help diagnose, treat, and prevent cancer.
R&D projects under SBIR and STTR are structured in three phases:
- Phase I, in which the technical merit and feasibility of proposed R&D projects are established and the quality of performance is determined before providing further support in Phase II. Phase I funding is normally $100,000 provided over a period of 6 months for SBIR and 1 year for STTR.
- Phase II, in which R&D projects initiated in Phase I are continued. Phase II awards normally may not exceed a total of $750,000. With proper justification, however, applicants may propose longer periods of time and larger amounts of funding necessary to establish the technical merit and feasibility of the proposed projects.
- Phase III, in which small businesses pursue, where appropriate and without SBIR/STTR funding, the commercialization objectives resulting from Phase I/II R&D projects.
SBIR/STTR and ARRA
NCI has used ARRA funding for two types of supplements to existing Phase II SBIR/STTR grants:
- Administrative supplements, which were designed to allow the hiring or retention of scientific personnel to address the job-creation goals of ARRA and to enhance the rate of commercialization of new cancer-related products and services. No expansion of work scope was permitted.
- Competitive revision supplements, which were designed to allow grantees to expand their scope of work (specific aims) and also allow the hiring or retention of scientific personnel and enhanced progress toward commercialization. Funds could be requested in any cost category (personnel, equipment, supplies, etc.).
SBIR/STTR grantees were allowed to apply for either an administrative supplement or a competitive revision supplement, but not both.
ARRA Supported SBIR/STTR ProjectsARRA funds in support of SBIR/STTR are addressing unmet needs in the areas of cancer diagnosis and treatment. For example:
- Development of new therapies: Senex Biotechnology, Inc. is developing drugs that inhibit tumor-promoting and other pathogenic activities of senescent cells. Drugs that effectively inhibit cell senescence will potentially be used in the treatment of both cancer and Alzheimer's disease. With the supplemental funds, the grantee will add a second round of optimization and in vivo testing for optimized lead compounds and hire two new full-time scientists, accelerating the program and speeding effective compound development.(1)
- Development of new therapies: Optimum Therapeutics, LLC is developing a paclitaxel nanoparticle (PNP) for bladder cancer that is easy to administer and requires only monthly treatment, with the goal of increasing patient compliance (current therapies require frequent treatments, and patient compliance is poor). The supplemental funding will support toxicology studies in a second animal species (rat), which is required by the FDA for approval of an Investigational New Drug (IND) Application, and will allow Optimum Therapeutics to hire a full-time research scientist and a subcontractor to sustain the equivalent of two full-time positions, thereby accelerating the program.(2)
- Imaging technologies and devices: Morphormics, Inc. is developing software for automatic segmentation of pelvic structures in CT images for use in prostate cancer radiation treatment planning and subsequent adaptive treatment modification. ARRA funding will support a full-time software engineer to accelerate development of the software and to allow for the inclusion of two additional structures, seminal vesicles and femurs, which will make the software more valuable to potential radiation oncology customers.(3)
- Imaging technologies and devices: Transpire, Inc. is developing software to support broad-beam, illumination-based fluorescence optical tomography for rapid whole-body imaging of cancer metastases in small animal models. Two postdoctoral researchers will be hired at Baylor College of Medicine and a software development engineer will be hired at Transpire to extend accurate photon transport computational algorithms to a number of commercially available planar small-animal imaging systems. In planar imaging, the detector array is stationary over object being imaged (animal or patient) and data are acquired only from this one angle. The image created with this planar imaging is similar to an X-ray. The accommodation of existing planar systems will increase the potential market for the software.(4)
- Diagnostics: Immunotope, Inc. is developing a diagnostic test for the early detection of hepatocellular carcinoma (HCC) that is more specific and sensitive than existing, approved diagnostic tests. ARRA funding will be used to hire PhD-level scientist and a research associate to expedite assay development. This company has received venture capital funding and is discussing a potential partnership with a large diagnostic company.(5)
- 3R44CA139991-03S1 — Inhibitors of disease-promoting activities of senescence — Senex Biotechnology, Inc. (NY)
- 3R44CA107743-04S1 — Rapid release paclitaxel nanoparticles for bladder cancer intravesicle therapy — Optimum Therapeutics, LLC (OH)
- 3R44CA119571-03S1 — System for automatic segmentation of male pelvis structures from CT images — Morphormics, Inc. (NC)
- 3R42CA115028-03S1 — RTE/FDPM for optical imaging of cancer in small animal models — Transpire, Inc. (WA)
- 3R42CA121506-03S1— HCC Diagnostics defined by fucosylated serum biomarkers — Immunotope, Inc. (PA)