Fast-Track proposals will be accepted.
Number of anticipated awards: 3-4
Budget (total costs, per award): Phase I: up to $300,000 for up to 9 months Phase II: up to $2,200,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Immunotherapies have emerged as one of the promising approaches for cancer treatment by exploiting patients’ own immune
systems to specifically target tumor cells. However, it has been recognized that responses often occur in only a subset of patients in any given immunotherapy. This treatment is also associated with drug toxicity (e.g., cytokine storm) and high cost. As this treatment modality continues to evolve, a significant clinical question that needs to be addressed is to determine which patients would benefit from immunotherapies. In addition, there is increasing need for newer methods to evaluate the efficacy and potential toxicities of the treatment, and monitor cancer patients’ prognosis.
Diagnostic imaging is routinely used to: 1) stratify patients for cancer treatment; and, 2) monitor and provide reliable predictive and/or prognostic information for a specific treatment. With the rapid advancement of imaging technologies, particularly molecular imaging technology development, this technique provides detailed visualizations and measurements of biologic processes taking place inside the body at molecular, cellular, and genetic levels. It offers capability to assess not only
changes in a patient’s tumor size, but also changes in molecular expression and cellular activity. Diagnostic imaging
provides nearly real-time information about tumor target expression levels, potentially allowing physicians to predict which patients may respond to therapies. In addition to patient stratification, diagnostic imaging of therapeutic targets may provide insight into the efficacy and toxicity of the cancer treatment and overall disease progression.
The purpose of this initiative is to provide much needed support for the development of diagnostic imaging technologies to identify patients who are likely to respond to cancer immunotherapies, evaluate the efficacy and potential toxicities of the treatment, and/or monitor cancer patients’ prognosis. The cancer immunotherapies for this topic will include the ones that either have been approved by the FDA, or are still under clinical development. This topic is intended specifically to address cancer immunotherapies that depend upon eliciting an immune response. Projects that do not meet this requirement will not be funded. For example, a monoclonal antibody based therapy that exerts a direct antitumoral effect either by neutralizing the antigen or by activating signaling pathways within the target tumor cells, but does not elicit an immune response for its clinical application, is not considered an immunotherapy and would not be funded. It should be noted that technologies that map the tumor and/or its microenvironment to predict response to immunotherapy should submit the proposal to the topic, “Imaging-Based Tools for Longitudinal and Multi-Dimensional Mapping of the Tumor and its Microenvironment.” The “Diagnostic Imaging for Cancer Immunotherapies” topic is in line with the Cancer Moonshot Blue Ribbon Panel’s Recommendation to support Development of New Enabling Cancer Technologies.
The goals of the project are to develop a diagnostic imaging technology to identify patients who are likely to respond to cancer immunotherapies, evaluate the efficacy and potential toxicities of the treatment, and/or monitor cancer patients’ prognosis. The imaging modality could be one of the following, but is not limited to: optical imaging, PET, SPECT, or MRI. Molecular markers of interest could include but are not limited to: cell surface receptors, immune cells, cellular infiltrates, enzymes, DNAs, or RNAs. The technology development should be platform driven. For example, the procedure for the diagnostic imaging that targets immunotherapy for breast cancer or its subtype should be easily applied for other cancer types/subtypes, such as colon cancer or prostate cancer. To apply for this topic, offerors need to outline and indicate the clinical question and unmet clinical need that their diagnostic imaging will address. Offerors are also required to use validated imaging targets. This solicitation will not support efforts for imaging biomarker discovery.
The long-term goal of this contract topic is to enable small businesses to bring novel modalities of fully developed diagnostic imaging for cancer immunotherapies to the clinic and the market.
Phase I Activities and Deliverables
Phase I activities should generate scientific data confirming the clinical potential of the proposed molecular diagnostic imaging for cancer immunotherapies. The Phase I research plan must contain specific, quantifiable, and testable feasibility milestones.
Expected activities may include:
Demonstrate proof-of-concept for the development of a diagnostic imaging technology to identify patients who are likely to respond to immunotherapies, and/or evaluate efficacy and toxicities of immunotherapy, and/or monitor tumor prognosis under immunotherapy using the imaging technology.
Quantify sensitivity and specificity of the imaging technology.
Conduct preliminary biosafety study for the imaging technology.
Present Phase I results and future development plan to NCI staff.
Phase II Activities and Deliverables
Phase II should follow the development plan laid out in the Phase I, and should further support commercialization of proposed diagnostic imaging for cancer immunotherapies. The Phase II research plan must contain specific, quantifiable, and testable milestones.
Expected activities may include:
Complete all pre-clinical and/or clinical experiments according to the development plan.
Demonstrate capability of diagnostic imaging to: 1) identify whether cancer animal models and/or human patients respond to cancer immunotherapies; and/or, 2) evaluate efficacy and toxicities of cancer immunotherapies in animal models and/or human patients; and/or, 3) monitor tumor prognosis in animal models and/or human patients under cancer immunotherapies.
Demonstrate high sensitivity and specificity of the imaging technology in animal models and/or human patients.
Demonstrate high reproducibility and accuracy of the imaging technology in animal models and/or human patients.
Determine biosafety of the imaging technology with animal or human toxicology studies.
If warranted, initiate FDA approval process for the candidate imaging technology.