Microbial-based Cancer Imaging and Therapy - Bugs as Drugs (R01 Clinical Trial Not Allowed) | PAR 22 085

Opportunity Information: Apply for PAR 22 085

The NIH, through the National Cancer Institute, is inviting R01 grant applications under PAR-22-085 titled "Microbial-based Cancer Imaging and Therapy - Bugs as Drugs (R01 Clinical Trial Not Allowed)." The central goal is to support research that uses microbes and microbe-derived products as tools to better understand, detect, image, and potentially treat cancer. The FOA is built around the idea that microorganisms can interact with tumors and the immune system in surprisingly specific ways, and that those interactions can be harnessed for practical cancer applications. This opportunity sits within a broader NCI effort focused on microbial-based cancer therapy, often described as "bugs as drugs," and it emphasizes learning the underlying biology while moving concepts toward translational readiness in preclinical settings.

Scientifically, the FOA is looking for projects that leverage bacteria, archaebacteria, bacteriophages, or other non-oncolytic viruses, as well as their natural products. A key point is that the announcement is not limited to using whole organisms; it also explicitly includes microbial components and products that can drive immune activation, tumor targeting, imaging signals, or therapeutic payload delivery. Applicants are encouraged to study the complex three-way relationship among microorganisms, tumors, and the immune system, including how microbes localize to tumors, how tumors shape microbial behavior, and how immune responses are altered by microbial presence or microbial molecules. The expectation is that funded work will clarify mechanisms rather than only showing an effect, meaning proposals should aim to explain why and how microbial approaches work in the tumor context.

On the application side, projects may take several directions as long as they align with cancer imaging, therapeutics, or diagnostics. One category includes using microorganisms directly as anti-tumor agents, for example by exploiting microbial tumor tropism, metabolic activity, or local replication patterns that can influence tumor viability. Another category involves using microbes as activators or modulators of anti-tumor immunity, such as stimulating innate immune sensing pathways, reshaping immune infiltration within the tumor microenvironment, or supporting systemic anti-tumor immune responses that can complement existing immunotherapies. A third category focuses on microbes as delivery vehicles, where engineered or naturally tumor-targeting microbes could carry drugs, immune stimulants, reporters, or imaging agents into tumors. The FOA also highlights complementarity and synergy with existing tools, so proposals that thoughtfully combine microbial strategies with established cancer treatments, imaging platforms, or diagnostic approaches are within scope, provided the work remains preclinical and mechanistic.

The research stage supported here is basic mechanistic and preclinical, specifically in cell culture and animal models. The title and instructions indicate "Clinical Trial Not Allowed," meaning the FOA is not intended to fund interventional studies in humans. Instead, it supports the types of studies that make a microbial approach credible and testable for future translation, such as defining microbial-tumor-immune interaction pathways, optimizing targeting or payload release, determining safety signals and biodistribution in animals, and developing imaging or detection readouts that are robust and reproducible. The announcement also explicitly notes relevance to microbial-based cancer therapy broadly, including therapies for oral cancer, and it encourages applicants to address both microbial and tumor biology rather than treating one side as a black box.

Eligibility is broad and includes many common U.S. applicant types: state, county, city, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. In practical terms, this wide eligibility signals NCI interest in drawing from diverse institutional settings and interdisciplinary teams, which fits the cross-cutting nature of microbial engineering, immunology, oncology, imaging, and diagnostic development.

Administratively, this is a discretionary grant mechanism using the R01 funding instrument, administered by NIH. The opportunity is associated with CFDA numbers 93.121, 93.395, and 93.396, and the original closing date listed is 2025-05-07. While the source text does not specify an award ceiling or expected number of awards, the R01 format generally implies investigator-initiated projects with substantial scope and multi-year plans, and applicants should use the FOA details to shape budgets and timelines consistent with R01 expectations and NIH policies.

In plain terms, this FOA is a fit for teams that want to turn microorganisms or their products into cancer-relevant tools, while also doing the hard work of explaining mechanisms and testing performance in rigorous preclinical models. Competitive projects will typically make a clear case for why a specific microbe or microbial product is well-matched to a specific tumor biology problem, how the immune system is expected to respond, what the measurable imaging/diagnostic/therapeutic endpoints are in model systems, and what milestones will move the approach closer to eventual clinical translation without crossing into human clinical trial work under this particular announcement.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Microbial-based Cancer Imaging and Therapy - Bugs as Drugs (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): 93.121, 93.395, 93.396.
• This funding opportunity was created on 2022-02-18.
• Applicants must submit their applications by 2025-05-07. (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 22 085

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