NOT-CA-21-079 - Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54 Clinical Trial Not Allowed)
National Cancer Institute (NCI)
The purpose of this Notice is to announce the NCI's intention to issue a Funding Opportunity Announcement (FOA) that invites applications for Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Data and Resource Coordination Center (DRCC) (U24).
In this FOA, cancer prevention means primary prevention of cancer before oncogenic process begins, while cancer interception is defined as disruption of oncogenic process during precancer stage. Precision cancer prevention-interception refers to an approach employing cancer preventive-interceptive interventions individually tailored for different populations with an increased risk of cancer (high-risk populations), such as those with hereditary cancer syndromes (HCS) and individuals diagnosed with high-grade precancerous lesions (precancer).
The CAP-IT program aims to functionally validate the critical roles of lead oncogenic targets (oncotargets) selected from previous or ongoing research studies and/or from existing databases of genomic and molecular profiles of precancer and cancer, and to discover innovative oncotarget-directed agents through in vitro and in vivo efficacy evaluation for precision cancer prevention-interception applications. The ultimate goals of the CAP-IT program are to advance newly discovered efficacious cancer preventive or interceptive agents to the existing preclinical development pipeline, PREVENT Program, for further development towards IND and early phase clinical trials conducted by Cancer Prevention Clinical Trials Network (CP-CTNet) and thereby establish a scientific roadmap and a more streamlined foundational infrastructure for fast-tracking agent discovery and development for cancer prevention and interception from bench to bedside.
The responsibilities of the CAP-IT DRCC will be to (1) establish a central CAP-IT database for network projects’ all relevant data for in-network data archiving and data sharing in accordance with the NCI-guidelines on Genomic Data Sharing Policy; (2) facilitate in-network sharing of new resources, including novel assay technologies, tools, preclinical biospecimens, and agents, which may be developed from the research conducted by the CAP-IT U54 Centers; (3) provide program management support, logistical and administrative assistance on in-network communications and cross-network collaborative activities; and (4) coordinate network-wide meetings, ad hoc workshops, seminars, steering committee meetings, and CAP-IT advisory panel meetings.
This Notice is being provided to allow potential applicants sufficient time to develop a responsive CAP-IT DRCC application. The companion notice for the Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Centers (U54) is NOT-CA-21-079.
The FOA is expected to be published in Summer 2021 with an anticipated application due date in Fall 2021. Details of the planned pre-application webinar will be announced in the Guide after publication of the FOA.
The FOA will utilize the U24 (Resource Related Research Projects Cooperative Agreements) activity code.
Details of the planned FOA are provided below.
Reduction in cancer mortality can be significantly improved if the full potential of effective cancer prevention-interception is realized through mitigation of cancer risk and better management of precancer, especially in individuals with HCS and those diagnosed with high-grade precancer, by harnessing the increasing knowledge of early drivers of oncogenic process. Because high-risk cohorts represent a diverse group of individuals with different genetic susceptibilities, varying histories of exposure to carcinogens, different lifestyles, age, gender, and the presence of other comorbidities, it is virtually impossible to find and deliver universally efficacious cancer preventive interventions in this heterogenous population. A more rational approach to cancer prevention and interception in the high-risk cohorts is to employ preventive measures specifically tailored for individual risk factors, an approach referred to as precision cancer prevention-interception in this FOA. Success of precision cancer prevention-interception clearly depends on two complementary steps. First, high-risk individuals need to be identified, e.g. through screening and early detection of precancer, some of which may progress to cancer, and testing for genetic susceptibility. Second, rather than (or in addition to) surgical resection or ablation, innovative, safe, and efficacious measures designed to reduce cancer risk or molecularly/immunologically intercept, arrest, and possibly eliminate precancer in these high-risk individuals are needed. However, current cancer interception strategies are predominantly centered on surgical interventions, as very few target-specific agents are available for these high-risk individuals. It is this gap in discovering and bringing molecular and immunological agents closer to the high-risk populations for cancer prevention and interception that the CAP-IT program will address.
The CAP-IT program’s overall research objectives are as follows:
1) To collaborate with NCI and other programs that have research focus on molecular profiling of precancer, early cancer, and/or oncogenic signaling pathways with emphasis on high-risk populations, and prioritize high-value oncotargets that can be potentially exploited for intervention
2) To functionally validate the critical roles of the high-value oncotargets in tumor initiation and/or progression to invasive cancer and select oncotargets suitable for targeted intervention strategies
3) To discover innovative intervention agents (molecular and immunological) through in vitro and in vivo efficacy evaluation and select promising efficacious agents for further preclinical development.
The CAP-IT program network structure: The CAP-IT program network will be formed by up to three U54 Specialized Centers (NOT-CA-21-079) and one U24 Data and Resource Coordination Center. The CAP-IT DRCC will function as the network data and resources hub for the entire CAP-IT program and support the overall network coordination by establishing a central CAP-IT database with network projects’ all relevant data, including experimental data from oncotarget validation studies, druggability and targetability assessment, feasibility assessment of immune-targeting approaches, and in vitro and in vivo activity evaluations of test agents; facilitating in-network sharing of new resources, including novel assay technologies, tools, preclinical biospecimens, and agents, which may be developed from the research conducted by the CAP-IT U54 Centers; providing program management support, logistical and administrative assistance on in-network communications and cross-network collaborative activities; and by coordinating network-wide meetings, ad hoc workshops, seminars, steering committee meetings, and CAP-IT advisory panel meetings. It is essential that the CAP-IT DRCC applicants familiarize themselves with the companion FOA for the CAP-IT U54 Centers, as the CAP-IT DRCC will be required to work closely with them. The CAP-IT DRCC may leverage, where possible, technology tools from NCI-sponsored informatics initiatives, including NCI Informatics Technology for Cancer Research (ITCR). CAP-IT investigators will be able to start collaborating with these programs upon inception of the program.
More details will be outlined in the forthcoming FOA.
$400,000 per year for five years.
$400,000 total cost per year.
Applications are not being solicited at this time.
Please direct all inquiries to:
Shizuko Sei, M.D.
Division of Cancer Prevention
National Cancer Institute (NCI)