Notice Number: NOT-CA-19-028

Key Dates
Release Date: March 5, 2019

PA-18-591
NOT-OD-19-042
NOT-CA-19-040

Issued by
National Cancer Institute (NCI)

Purpose

Through funds available from the Cancer Moonshot Initiative^SM, and pursuant to the NIH interest in advancing human tissue models that do not rely on human fetal tissue (NOT-OD-19-042), the National Cancer Institute (NCI) is inviting applications for administrative supplements to improve representation of the human immune system in ongoing cancer modeling development projects that can be utilized in immuno-oncology research. Progress for cancer research is highly dependent on the model systems 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 (https://www.niaid.nih.gov/research/humanized-mouse-model-workshop). HIS mice are used extensively in immuno-oncology research, which is a high priority field of research with support through the Cancer Moonshot Initiative.

NCI supports a number of oncology model development efforts through a variety of mechanisms spanning both in vitro and in vivo model systems. Through funds available from the Cancer Moonshot Initiative, NCI is announcing the opportunity for investigators with relevant active research project grants and cooperative agreements to submit administrative supplement requests according toPA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements(Parent Admin Supp Clinical Trial Optional), to advance either an in vivo or in vitro model system to more closely recapitulate aspects of the human immune system in the context of the tumor microenvironment, in a manner that directly supports immuno-oncology research. Specifically, the NCI seeks to support projects that replace the use of human fetal tissue to model the tumor microenvironment with a more faithful representation of the human immune system.

Proposed research projects must be within the scope of the ongoing parent award and based on a model system that is beyond early stages of development to model cancer biology and the proposed research efforts must address recapitulating the tumor microenvironment with appropriate elements of the human immune system. Applicants for these supplements 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 human fetal tissue-based models and approaches. Applicants must propose appropriate performance measures that must be met to provide sufficient and objective proof 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 (but not required) to collaborate with immuno-oncology investigators to develop applications and to participate in proposed research. All awardees must adhere to the policies of the Cancer Moonshot Initiative (e.g., data sharing policy).

In advance of preparation and submission of an administrative supplement request (i.e., application), inquiries from eligible awardee-applicants in response to this Notice (through PA-18-591), the related funding opportunity through PA-18-591, and any potential requests to appropriate NCI staff persons are encouraged.

Budget

To be eligible, the parent award must be able to receive funds in FY19 (October 1, 2018 - September 30, 2019) and must not be in an extension period.

Supplement budget requests cannot exceed $125,000 in direct costs exclusive of Facilities and Administrative costs on sub-awards, and they cannot exceed the direct costs of the current parent award. Requests must reflect the actual needs of the proposed project. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as the research objectives are within the original scope of the peer reviewed and approved project, or the cost increases are for unanticipated expenses within the original scope of the project. Requests are permitted for 1 year of support only. Modular and categorical budgets are permitted.

The earliest anticipated start date is August 12, 2019.

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active grant or cooperative agreement from the NCI. For supplements to parent awards that include multiple program directors/principal investigators (PDs/PIs), the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Submitting Applications

Supplements to Grants/Cooperative Agreements:

For administrative supplement to grants and cooperative agreements, supplement requests must be submitted in accordance with the parent program announcement PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional).

Applicantsshouldbegin the supplement application abstract by stating This application is being submitted in response to NOT-CA-19-028.

Supplement requests should be submitted electronically if allowed by the parent mechanism. Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Page Limits:

The Research Strategy should not exceed 5 pages, not including the abstract.

Due Date:

All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on June 3, 2019, for funding in FY 2019.

Scientific Review Process:

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds.

Critical Considerations:

1. Is the work proposed within the scope of the active award?
2. Does the work proposed introduce new aspects of the human immune system into the relevant model system in a manner that can serve immuno-oncology research?
3. Does the work proposed have scientific merit?

Inquiries

Please direct all inquiries to:

Tony Dickherber, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-547-9980
Email:[email protected]