Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 Clinical Trial Not Allowed) | PAR 22 061

Opportunity Information: Apply for PAR 22 061

The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 Clinical Trial Not Allowed)" (PAR-22-061). The goal of this funding announcement is to support basic, mechanistic research that explains how the human microbiome can either strengthen or weaken anti-tumor immune responses, and how those microbiome-driven effects might be leveraged to identify new molecular targets for cancer prevention. The emphasis is on understanding cause-and-effect biology rather than running human intervention trials, since clinical trials are explicitly not allowed under this announcement.

Proposed projects are expected to drill into the mechanisms linking specific microbes (individual species or defined microbial consortia) and/or their metabolites to immune pathways that influence tumor development. A central theme is host-microbe interaction: how the immune system senses and responds to particular microbes, how microbial products shape immune cell function, and how these interactions either promote protective anti-tumor immunity or contribute to immune states that enable cancer. The announcement specifically calls out research relevant to both inflammation-associated cancers and sporadic tumor formation, meaning it can support work on cancer arising from chronic inflammatory environments as well as cancers that develop without an obvious inflammatory precursor, as long as microbiome-immune mechanisms are clearly central.

A notable point in the scientific scope is the expectation that applicants will rigorously address parameters that often determine whether a beneficial microbe (or microbiome-based approach) actually works. The FOA highlights concentration (dose), timing (when exposure or administration occurs), and duration (how long it is given or persists) as variables that can change the effect of administered beneficial microbes. Applications that involve introducing or modulating beneficial microbes should therefore treat these variables as core experimental factors rather than afterthoughts, with careful design to test how each parameter impacts immune outcomes relevant to tumor prevention or control.

From an administrative standpoint, this is a discretionary NIH grant using the R01 funding instrument, and it falls under CFDA numbers 93.393 and 93.396. The opportunity was created on November 3, 2021, and lists an original closing date of January 7, 2025. While an award ceiling and expected number of awards are not specified in the provided source data, the R01 mechanism typically supports substantial, multi-year research programs where applicants are expected to propose a strong rationale, solid preliminary or supporting evidence when appropriate, and a clear plan for mechanistic discovery.

Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (both with and without 501(c)(3) status, excluding higher education institutions when applicable); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities/foreign organizations, Indian/Native American Tribal Governments other than federally recognized, and U.S. territories or possessions. This wide eligibility reflects an intent to draw in multidisciplinary microbiome, immunology, and cancer biology expertise from diverse institutional settings.

Overall, the opportunity is designed for researchers who can connect the dots between microbiome composition or function and immune mechanisms that influence cancer risk or early tumor development, with an eye toward identifying actionable molecular targets for prevention strategies. Competitive applications will typically be those that move beyond correlation, carefully define microbial players or metabolites of interest, map the immune pathways they affect, and demonstrate a thoughtful approach to variables like dose, timing, and duration when manipulating microbes or their products in experimental systems, all while staying within the bounds of non-clinical-trial research.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Modulating Human Microbiome Function to Enhance Immune Responses Against Cancer (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.396.
• This funding opportunity was created on 2021-11-03.
• Applicants must submit their applications by 2025-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 PAR 22 061

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: