Notice of Intent to Publish: Funding Opportunity Announcement for Human Immune-Representing Oncology Models for Immuno-Oncology Research (R33 Clinical Trial Optional)

Notice Number: NOT-CA-19-047

Key Dates

Release Date:January 12, 2018
Estimated Publication Date of Funding Opportunity Announcement: June 01, 2019
First Estimated Application Due Date: November 01, 2019
Earliest Estimated Award Date: June 01, 2020
Earliest Estimated Start Date: July 01, 2020

Related Announcements

Issued by
National Cancer Institute (NCI)


In support of the Cancer MoonshotSMInitiative to accelerate cancer research and the NIH priority for advancing human tissue models that do not rely on human fetal tissue (NOT-OD-19-042), this funding opportunity seeks new cancer model development research projects with a focus on recapitulating innate and adaptive components of the human immune system, in a manner that addresses the needs of immuno-oncology research. Progress for cancer research is highly dependent on the model systems being employed. While substantial progress has been made to establish models of increasing complexity to recapitulate aspects of human disease, a critical shortcoming persists for representation of the human immune system in those models. For example, various models can recapitulate key aspects of human T cell immunity but are less able to recapitulate human innate immunity and antibody responses, regardless of the human tissue source. In addition, few direct comparisons have been conducted of mice with humanized immune systems (HIS) derived using fetal vs. non-fetal human tissue sources ( HIS mice are used extensively in immuno-oncology research, which is a high priority field of research with support through the Cancer Moonshot Initiative, and models that use human fetal tissue (HFT) remain the most advanced for mimicking human immune functions. More accessible model systems that account for human immune function are critically important for advancing this area of research.

This Notice is being provided to allow potential applicants sufficient time to develop responsive projects. The FOA is expected to be published in June 2019 with an expected application due date in November 2019.

The FOA will utilize the R33 Exploratory/Developmental Grants Phase II research activity code. Details of the planned FOA are provided below.

Research Initiative Details

The goal of this FOA is to advance cancer model systems that recapitulate human immunity in the tumor microenvironment to improve the predictivity of immuno-oncology studies. Proposed research projects must focus on recapitulation of the human immune system in their proposed cancer model using human cells or tissues to regenerate and/or recapitulate the human immune system in in vivo or in vitro immuno-oncology models in a manner that matches or exceeds representation of the human immune system achieved with murine models developed using HFT. Models derived from genetically manipulated immune systems without introduction of human immune lineage cells will not be considered responsive.

Applicants must explain which aspects of the human immune system their proposed model intends to reproduce and justify why their model would be a reliable or improved alternative for immuno-oncology research compared to existing HFT-based models and approaches. Applicants must propose appropriate performance measures that must be met to objectively substantiate that the proposed model will be ready for adoption by targeted end-users and will offer genuine potential for transformative impact in immuno-oncology research. Supported projects will be incorporated into ongoing Cancer Moonshot initiatives, as appropriate. Applicants are encouraged to collaborate with immuno-oncology investigators to develop applications and participate in the proposed research. All awardees must adhere to the policies of the Cancer Moonshot Initiative (e.g., public access and data sharing policy).

Funding Information

Estimated Total Funding $4.0 M
Expected Number of Awards 2-3
Estimated Award Ceiling Application budgets are limited to $250,000 in direct costs per year, for up to 4 years.
Primary CFDA Numbers 93.393

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.



Please direct all inquiries to:

Tony Dickherber, Ph.D.
National Cancer Institute (NCI)