Pediatric Immunotherapy Discovery and Development Network (PI-DDN)(U01 - No Clinical Trial Allowed) | RFA CA 19 004

Opportunity Information: Apply for RFA CA 19 004

The Pediatric Immunotherapy Discovery and Development Network (PI-DDN) funding opportunity (RFA-CA-19-004) is an NIH cooperative agreement (U01) designed to speed up progress in pediatric cancer immunotherapy as part of the Beau Biden Cancer Moonshot Initiative. Its core purpose is to build a coordinated, collaborative network of investigators who can move promising immunotherapy ideas for children and adolescents with cancer closer to clinical use. The emphasis is on translation-focused science that helps bridge the gap between basic discovery and future clinical applications, while staying within the limits of a U01 mechanism and the specific restriction that clinical trials are not allowed under this announcement.

Scientifically, the FOA is tied to the Cancer Moonshot Blue Ribbon Panel (BRP) Recommendation B, which called for a pediatric immunotherapy translation science network. In practical terms, NIH is looking for research that identifies and validates new immunotherapy targets relevant to pediatric tumors, develops pediatric-appropriate immunotherapy strategies (including but not limited to cancer vaccines, cellular therapies, and rational combinations of immunotherapy agents), and explains the underlying biology of how pediatric cancers avoid or suppress immune responses. The announcement highlights project themes such as mechanisms of immune evasion, development of models that better reflect pediatric disease and immune context, and validation work around a single target or approach that could later be advanced toward the clinic through separate clinical mechanisms.

This FOA specifically solicits discrete, standalone research projects through the U01 activity. The U01 is a cooperative agreement, meaning awardees should expect substantial NIH programmatic involvement compared with a standard research grant. Successful U01 awardees become members of the broader PI-DDN and are expected to function as part of an organized network, sharing insights and aligning efforts to implement the BRP vision. The FOA is paired with companion announcements that support other pieces of the network: a companion U54 center-style funding opportunity supports multi-component center applications, while this U01 opportunity supports focused projects that plug into the larger network strategy.

From an applicant eligibility standpoint, the opportunity is open to a wide range of domestic organization types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly notes inclusion of various institution types and community-based entities such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions, as well as faith-based or community-based organizations and eligible federal agencies.

There are important restrictions regarding foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed. This typically means a U.S. applicant organization can include certain types of scientifically justified foreign involvement as components, but the applicant itself must be domestic and must comply with NIH rules on foreign components.

Administratively, this opportunity is categorized under health (CFDA 93.353) and uses the cooperative agreement funding instrument. The original closing date listed for the FOA was December 17, 2018, and the ceiling shown in the source information is $499,999. Overall, the announcement is best read as NIH building infrastructure and momentum for pediatric immunotherapy translation by funding individual, well-scoped research projects that are expected to integrate into a national network, generate shareable knowledge and tools (such as models and validated targets), and set the stage for future clinical development without conducting clinical trials under this specific award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pediatric Immunotherapy Discovery and Development Network (PI-DDN)(U01 - No Clinical Trial Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.353.
• This funding opportunity was created on 2018-08-13.
• Applicants must submit their applications by 2018-12-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $499,999.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA CA 19 004

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