Description:
Fast track proposals will be accepted. Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 2-3 Budget (total costs, per award): Phase I: up to $400,000 for up to 9 months; Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
Determining the best treatment for each individual cancer patient can be a difficult task. To make that decision, clinicians rely on information such as the tumor type and stage, the presence of certain prognostic markers, and specific genetic characteristics of the tumor. Nevertheless, it is not always possible to determine whether a patient will respond to a specific therapeutic agent; and in some cases, several rounds of varied treatments are required to find one that is effective in a given patient. An emerging possibility identified by the Cancer Moonshot Blue Ribbon Panel (BRP) is to use the patient’s own tumor to safely and simultaneously test sub-therapeutic doses of multiple candidate drugs to more efficiently determine the most effective therapeutic agent(s). A major advantage of this strategy is that it can be personalized to each individual patient, thus allowing clinicians to more rapidly determine whether a patient will respond to a specific agent or drug combination. This capability would allow clinicians to optimize treatment decisions not only at the early stages of treatment, but also during later stages of treatment to address acquired resistance to initial therapies. In the future, such technologies might be used to generate pharmacotyping data that would accompany genotyping data in databases from large numbers of patients, which could be further mined to predict sensitivity to certain drugs and drug combinations. The BRP identified several
emerging technologies that might contribute to such a “pharmaco-typing” capability; however, further development and validation of these technologies is needed before they are ready to be deployed in a clinical setting.
Project Goals
The primary goal of this topic is to expand the capabilities that can enable these emerging pharmaco-typing approaches by developing intra-tumoral sensing technologies. Proposals under this topic must involve the in vivo measurement of specific intra-tumoral markers of anti-cancer activity that are triggered in response to the delivery of sub-therapeutic doses of candidate therapeutic agents. Responsive proposals must offer approaches that can eventually report on patient-specific efficacy from a variety of potential treatment options while maintaining patient safety. To demonstrate the sensing capabilities of their technologies, offerors may utilize any route of administration to deliver candidate therapeutic agents (e.g., intratumoral administration, multiple/sequential rounds of systemic dosing, or other delivery strategies). However, the proposed sensing technology and/or process must enable sufficient throughput to evaluate an appropriate number of therapeutic agents that would be needed to inform clinical decision-making within a relevant timeframe.
For Phase I projects, offerors must demonstrate intra-tumoral sensing capabilities using at least one solid tumor animal model; however, technologies that are capable of intra-tumoral sensing in multiple solid tumors are preferred. In all cases, offerors must provide a scientific justification for the methods, assays, and metrics that will be used to identify the optimal therapeutic agent or combinations that will be tested in their chosen tumor model(s). For Phase II projects, offerors will be expected to further develop the technology and/or process for use in human patients. Small businesses developing more mature technologies may advance far enough during Phase I to propose clinical trials during their Phase II projects; therefore, clinical trials will be allowed for Phase II SBIR contracts but will not be required.
Phase I Activities and Deliverables
• Demonstrate intra-tumoral sensing capabilities using at least one solid tumor animal model
• Conduct proof-of-concept experiments using an appropriate number of anti-cancer agents, combinations, and/or doses (at least four) to demonstrate throughput capability that would eventually support clinical decision-making for the chosen tumor(s)
• Conduct preliminary safety studies in the chosen animal model (animal safety studies may be limited in scope, but they should provide early evidence that the technology is likely to support human testing without compromising patient safety or interfering with standard of care)
Phase II Activities and Deliverables
• Perform testing in multiple solid tumor models and/or PDX models to advance the technology for clinical testing in specific solid tumors
• Conduct preclinical studies as required for regulatory approval of the device and/or a specific clinical test
• Conduct clinical trials in animals (as appropriate)
• Conduct human clinical trials (as appropriate)
• Complete other activities required for regulatory approval and/or marketing of the technology or test
