Microbial-based Cancer Therapy -Bugs as Drugs (R01 Clinical Trial Not Allowed) | PAR 19 193

Opportunity Information: Apply for PAR 19 193

Microbial-based Cancer Therapy - Bugs as Drugs (R01 Clinical Trial Not Allowed) is an NIH research grant opportunity (PAR 19-193) designed to push forward new ways of treating cancer using microbes as therapeutic tools. The central idea is to support innovative, state-of-the-art preclinical research that explores how non-viral microorganisms such as bacteria, archaebacteria, and bacteriophages can be used either as direct anti-cancer agents or as engineered platforms that deliver cancer treatments more precisely. A major emphasis is placed on cancers where standard treatments often fall short, including poorly vascularized and hypoxic solid tumors, tumors with dormant or slowly dividing cells that resist chemotherapy and radiation, and difficult-to-treat settings like brain tumors.

This FOA focuses on understanding and harnessing the complex three-way relationship between the microorganism, the tumor, and the immune system. Projects are expected to dig into mechanisms, meaning investigators should aim to explain how microbial therapies localize to tumors, survive or function in hostile tumor microenvironments, stimulate or reshape anti-tumor immunity, and interact with tumor biology in ways that can be exploited therapeutically. The opportunity also encourages work where microbes act as delivery vehicles, for example by carrying immune-stimulating molecules, tumor-targeted toxins, enzymes that activate prodrugs within the tumor, or other payloads meant to improve effectiveness while limiting systemic toxicity. Another key theme is combining microbial approaches with existing cancer treatments, with the goal of complementing or creating synergy with modalities like immunotherapy, chemotherapy, radiation, or targeted therapy.

Only basic mechanistic and preclinical studies are supported under this announcement, specifically in cell culture systems and animal models, consistent with current scientific capabilities. As the title states, clinical trials are not allowed, so applications need to remain firmly on the pre-human side of development. At the same time, the work should be translationally relevant: proposals should aim to advance the preclinical development pipeline for microbial-based anticancer agents or substantially deepen scientific understanding of microbe-tumor-immune interplay in ways that clearly inform therapeutic design. The FOA is flexible in the types of scientific approaches it welcomes, allowing design-directed engineering efforts, developmental and discovery-driven studies, and hypothesis-driven research, as long as the overall strategy is integrative and clearly connected to microbial-based cancer therapy.

A defining requirement is that applications must address both the microbial aspect and the tumor aspect of the problem. In other words, it is not enough to study a microbe in isolation, or to study a tumor response without meaningfully incorporating the microbial system. Because these interactions are inherently complex, the FOA strongly encourages multidisciplinary collaborations. Competitive teams are expected to draw on expertise across areas such as microbiology, oncology, immunology, and cellular and molecular cancer biology, reflecting the reality that progress in this space often depends on combining microbial engineering and characterization with rigorous tumor biology and immune profiling.

From an eligibility standpoint, the applicant pool is broad. In addition to typical academic and nonprofit research organizations, eligible applicants include various levels of government entities, public and private institutions of higher education, and for-profit organizations (other than small businesses), along with small businesses. The FOA explicitly notes inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), among others. The sponsoring agency is the National Institutes of Health, the funding mechanism is an R01 research project grant, and the relevant CFDA numbers listed are 93.395 and 93.396.

Overall, this opportunity is aimed at expanding the scientific and preclinical foundation needed to make microbial-based cancer therapies real and reliable, particularly for tumor types and microenvironments that remain stubbornly resistant to conventional options. The strongest applications under this FOA would typically present a clear microbial strategy, a clear cancer biology rationale, and a well-integrated plan to measure mechanistic outcomes in tumors and immune responses using rigorous preclinical models, with a realistic path toward eventual therapeutic development even though human trials are outside the scope of this announcement.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Microbial-based Cancer 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): 93.395, 93.396.
• This funding opportunity was created on 2019-02-22.
• Applicants must submit their applications by 2022-02-18. (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 19 193

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