Help NIAID fight invasive fungal infections that remain a clinical challenge by applying to the Discovery and Development of Novel Therapeutics for Select Fungal Pathogens (R21/R33, Clinical Trial Not Allowed) notice of funding opportunity (NOFO). This NOFO seeks milestone-driven, early-stage translational research focused on drug discovery and development of novel therapeutics against select fungal pathogens including Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales.
Phased Innovation Awards
Due to the high-risk, high-impact nature of the research, this NOFO will use the R21/R33 Exploratory/Developmental Phased Award activity code. In this biphasic award mechanism, specific milestones during the R21 phase must be successfully completed in order to transition to the R33 phase.
During the R21 phase, funding will support up to 2 years of milestone-driven research that enables proof-of-concept for novel therapeutic targets and/or candidate therapeutics specific to select fungal pathogens and describes how the therapeutic concept/candidate will be further developed in the R33 phase. During the R33 phase, funding will support an additional 3 years to engage in additional activities as appropriate, such as expanded development of the candidate therapeutics developed during the R21 phase. We expect that candidate therapeutics will be at the preclinical development stage by the end of the R33 phase. Proposed transition milestones will be reviewed and negotiated prior to award.
Before the end of the R21 phase, recipients will submit the R33 transition package, which includes a detailed progress report describing advancement toward the transition milestones and a description of how the completed work justifies continuation with the originally proposed R33 studies. NIH program staff will evaluate these materials. Awards selected for continued funding will transition to an R33 award without the need to submit a new application. Transition to the R33 is neither automatic nor guaranteed. R33 funding decisions will be based on the original R21/R33 peer review recommendations, successful completion of transition milestones, program priorities, and availability of funds. We expect approximately 50 percent of awards funded in the R21 phase to transition to the R33 phase. For more information, refer to the Phased Award SOP.
Scope of Research
This initiative will support research projects focused on discovery and development of novel therapeutics against select fungal pathogens of clinical concern. Examples of potential approaches to be supported include, but are not limited to:
- Discovery and validation of novel fungal pathogen-specific or host-specific therapeutic targets using synthetic disease models or animal models. Exploitation of targets common to yeasts, dimorphic fungi, and molds is strongly encouraged.
- Identification and/or development of novel compounds that circumvent resistance mechanisms.
- Identification and/or development of novel compounds with broad-spectrum activity against select fungal pathogens.
- Characterization/down-selection of novel compounds and/or preclinical development of lead candidates.
Refer to the NOFO for information about review criteria.
Applications proposing the following will be considered nonresponsive and will not be reviewed:
- Projects not targeting at least one of the following priority fungal pathogens: Candida species, specifically Candida auris; Aspergillus fumigatus; Coccidioides; and Mucorales.
- Projects proposing to develop vaccine agents or adjuvants.
- Projects proposing to conduct investigational new drug-enabling studies.
- Projects proposing to conduct Good Manufacturing Practices manufacturing.
- Applications without a section with proposed transition milestones.
- Projects that propose clinical trials. However, clinical development strategies may be included within an overall project.
Be sure to review the Specific Aims and Research Strategy sections of the NOFO to appropriately describe the planned research approach, address strategies, and provide proposed milestones.
Application Budgets
Application budgets are limited to $275,000 in direct costs over the 2-year R21 project period, with a maximum of $200,000 in direct costs allowed in any single year. For the R33 award phase, application budgets are not expected to exceed $300,000 in direct costs per year and should reflect the actual needs of the project. The maximum project period for an application submitted in response to this NOFO cannot exceed 5 years total.
Submission Information
Applications are due by January 28, 2025, at 5 p.m. local time of the applicant organization. Take note, this due date means you will need to use FORMS-I for your application. Likewise, that receipt date means reviewers will use NIH’s new Simplified Peer Review Framework to review your application.
Direct any scientific/research questions to Dr. Baoying Liu at baoying.liu@nih.gov or 301-627-3697. For questions about peer review, contact Dr. Annie Walker-Abbey at aabbey@niaid.nih.gov or 240-627-3390.