Partnerships for the Development of Novel Therapeutics to Combat Select Antibiotic Resistant Bacteria and Fungi (R01 Clinical Trial Not Allowed) | RFA AI 22 028

Opportunity Information: Apply for RFA AI 22 028

The grant opportunity "Partnerships for the Development of Novel Therapeutics to Combat Select Antibiotic Resistant Bacteria and Fungi (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-AI-22-028) is a National Institutes of Health (NIH) discretionary grant program aimed at pushing promising anti-infective products closer to real-world use by funding milestone-driven, preclinical development work. The central goal is to support projects that already have a credible lead therapeutic (or closely related countermeasure) and now need focused development to strengthen the case for eventual clinical advancement. Clinical trials are not permitted under this announcement, so the work is intended to stay in the preclinical stage, such as optimization, characterization, and other development steps that reduce risk before first-in-human studies.

The scientific focus is narrow and targeted to urgent public health threats: antibiotic-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacteriaceae, and the fungal pathogen Candida auris. These organisms are well known for causing difficult-to-treat healthcare-associated infections and for developing resistance to multiple drug classes. Applications are expected to be aligned with the practical challenges of developing effective therapeutics against these pathogens, meaning applicants should be prepared to show that their lead candidate has a defensible rationale, plausible activity against relevant resistant strains, and a development plan that addresses common preclinical hurdles like efficacy models, pharmacology, formulation considerations, safety signals, and manufacturing or quality issues as appropriate for the modality.

A defining feature of the program is that it is milestone-driven. Rather than funding open-ended discovery research, the FOA is structured around concrete, measurable development objectives that allow progress to be tracked and decisions to be made based on data. This typically implies a development-style project plan with clear go/no-go criteria, timelines, and deliverables, similar to how translational programs or industry development teams manage risk and progression. Applicants must also include a Product Development Strategy attachment, which signals that NIH expects a coherent plan describing how the product will move from its current state through preclinical readiness and toward later-stage development. In practice, that kind of strategy usually covers the target product profile, the key studies needed to justify advancement, how the team will manage regulatory and development requirements, and how manufacturing, formulation, and scale-up considerations will be handled if relevant.

The FOA strongly encourages substantive investment by industrial participants. While not necessarily mandatory in every case, the emphasis indicates NIH wants genuine partnership and tangible buy-in from industry, such as co-funding, in-kind contributions, access to proprietary platforms, manufacturing capabilities, specialized assays, regulatory expertise, or other resources that materially accelerate development. The underlying idea is that therapeutics development against resistant pathogens benefits from the rigor, infrastructure, and product-focused mindset that industry partners often bring, and that shared investment can increase the likelihood that a candidate actually progresses beyond the academic preclinical stage.

In terms of who can apply, eligibility is broad and spans many organization types. Eligible applicants include various levels of government (state, county, city or township, and special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized tribal governments, tribal organizations that are not federally recognized governments, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations (including those other than small businesses), and small businesses. The FOA also explicitly highlights additional eligible applicant categories 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 (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This breadth suggests NIH is open to proposals from academic groups, biotech and pharma partners, nonprofit research organizations, and cross-sector consortia, including international contributors, as long as the work fits the program scope.

Administratively, this is an NIH R01 grant mechanism in the health area (Funding Activity Category: Health; CFDA Number: 93.855). The original closing date listed for the opportunity was July 29, 2022, and the FOA was created on April 5, 2022. The award ceiling is listed as $650,000, indicating an upper bound on funding per award under the terms presented in the source data. The announcement also lists "Expected Awards:" without a number, which implies the exact number of awards may not have been specified in the excerpted data or may depend on available funds and application quality.

Overall, the program is best understood as a translational, product-oriented funding opportunity designed to move credible lead therapeutics for a short list of high-priority resistant bacterial and fungal threats through key preclinical development milestones. It favors applicants who can present a disciplined development plan, define measurable milestones, and demonstrate that the project is positioned to produce a development-ready package rather than simply exploratory research results, with added emphasis on meaningful industry participation to help bridge the gap between laboratory findings and deployable countermeasures.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for the Development of Novel Therapeutics to Combat Select Antibiotic Resistant Bacteria and Fungi (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): 93.855.
• This funding opportunity was created on 2022-04-05.
• Applicants must submit their applications by 2022-07-29. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $650,000.00 in funding.
• 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.

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