Description:
- Imaging for Cancer Immunotherapies
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 $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Summary
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), potential development of autoimmune diseases, in addition to the 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, monitor cancer patients’ prognosis, and implement early interventional steps to minimize adverse effects upon completion of immunotherapies.
Cancer 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, this technique provides detailed visualizations and measurements of biologic processes taking place inside the body at molecular, cellular, anatomical, and functional levels. As such, imaging capability offers capability to assess early changes in molecular expression, cellular activity, and functional perturbation in response to therapies. Furthermore, cancer 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, cancer imaging of therapeutic targets may provide insight into predicting efficacy and reducing toxicity of the cancer treatment and overall disease progression.
The purpose of this initiative is to provide much needed support for the development of cancer imaging technologies or approaches 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’ treatment prognosis. This solicitation 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.
Project Goals
The goals of the solicitation are to develop a cancer 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: ultrasound imaging, optical imaging, photoacoustic imaging, PET, SPECT, MRI or combination of multiple modalities. Molecular markers of interest could include but are not limited to: cell surface receptors, immune or associated non-immune cells, cellular infiltrates, enzymes, metabolites or metabolic states, DNAs, RNAs, or epigenetic modifications. The technology development should be platform driven. For example, the procedure for the cancer 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 cancer imaging will address. Offerors are also required to use novel or validated imaging targets. This solicitation will not support efforts for imaging biomarker discovery
The long-term goal of this solicitation is to enable small businesses to bring novel or improved imaging modalities of fully developed imaging technologies for cancer immunotherapies to the clinic and the market.
Phase I Activities and Deliverables:
Expected activities may include:
- Demonstrate proof-of-concept for the development of a novel, modification of an existing imaging technology or approach 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 such imaging technology or approach.
- Conduct preliminary biosafety study for the imaging technology or approach.
- Benchmark experiments against current state-of-the-art methodologies.
- 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 imaging technology for cancer immunotherapies. The Phase II research plan must contain specific, quantifiable, and testable milestones.
Expected activities may include:
- Complete all experiments according to the development plan.
- Demonstrate capability of imaging technology 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.
National Heart, Lung, and Blood Institute (NHLBI)
The NHLBI plans, conducts and supports research, clinical trials and demonstration and education projects related to the causes, prevention, diagnosis, and treatment of heart, lung, and blood (including blood vessel), and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on all product and service development related to the mission of the NHLBI.
For more information on the NHLBI SBIR/STTR programs, visit our website at: https://sbir.nih.gov/nhlbi
Limited Amount of Award
For budgetary, administrative, or programmatic reasons, the NHLBI may not fund a proposal and does not intend to fund proposals for more than the budget listed for each topic.
NHLBI Topics
This solicitation invites proposals in the following areas:
