Microbial-based Cancer Therapy - Bugs as Drugs (R21 Clinical Trial Not Allowed)

LOI due 30 days prior to the application due date
Brief Description


The purpose of this funding opportunity announcement (FOA) is to encourage submissions of applications that propose early stage studies of novel microbial-based cancer therapies to treat cancers that are inadequately addressed by conventional cancer therapies, or their use as delivery vehicles for cancer treatment to complement or synergize with current therapies.

Examples include, but are not limited to poorly vascularized, hypoxic, solid tumors, dormant or slowly dividing cells resistant to current interventions, and brain tumors. Solutions may utilize bacteria, archaebacteria, bacteriophages and other non-virus microorganisms, Oncolytic virus-based cancer therapies are not supported by this FOA.

This initiative will support research projects on the underlying mechanisms of the complex interactions between microorganisms, tumor, and immune system, and their use as delivery vehicles for cancer treatment to complement or synergize with current therapies. This FOA will accept basic, mechanistic and/or preclinical studies in cell culture and animal models in accordance with the state of the science. Applicants responding to this FOA are encouraged to address both the microbial and the tumor aspects of microbial-based cancer therapy.

Applicants are encouraged to propose basic or applied research that require both microbiology and cancer research expertise. The proposed projects may involve considerable risk and should be aimed at producing breakthrough pre-clinical development of novel microbial-based anticancer therapeutic agents, or study the biology involved in the interplay of microbe-tumor-immune system. An application may propose design-directed, developmental, discovery-driven, or hypothesis-driven research, and should apply an integrative approach to increase our understanding of biological, or translational aspects of microbial-based anticancer therapeutic agents.

This FOA utilizes the R21 award mechanism for exploratory/developmental projects. The R21 mechanism is suitable for projects that are at their inception, conceptual, or idea-based phase where proof-of-principle of the proposed methodology has not been established with the aim to demonstrate core functional capabilities of the proposed approach. In this phase, technical feasibility of the proposed technology or methodology should not yet have been established. Preliminary data are not required but are accepted if available. If preliminary data are sufficient to suggest the feasibility of the approach is established, then consideration should be given to submitting to the companion R01 FOA PAR-19-193.

Exploratory/Developmental Research Grant applications should be distinct from those supported through the traditional R01 activity, which are generally more advanced, longer-term systematic investigations supported by extensive preliminary data and designed to increase knowledge in an established area. Studies submitted to this R21 FOA should break new ground or take previous discoveries in new directions. R21 applications should have well-defined goals with potential for future development.

This FOA runs in parallel with a companion FOA of similar scientific scope that invites projects ready for more advanced development, optimization, and validation work, PAR-19-193 which uses the Research Project (Grant R01) activity. It is the appropriate FOA for more mature applications that include preliminary data that demonstrate the feasibility of the specific aims.