Engineering and Preclinical Development of Biological Products that Eliminate HIV-infected Cells (UG3/UH3 Clinical Trial Not Allowed) | RFA AI 23 060

Opportunity Information: Apply for RFA AI 23 060

This NIH funding opportunity (RFA-AI-23-060) is a discretionary, cooperative-agreement program aimed at pushing promising anti-HIV biological products through late-stage engineering and rigorous preclinical development, with the specific goal of creating agents that can safely and selectively eliminate HIV-infected cells. The scientific focus is not on general HIV suppression or prevention, but on designing or refining biologics that directly target infected cells for killing, a key need for cure-oriented strategies. The NOFO explicitly excludes clinical trials, meaning the work supported should remain in the engineering, optimization, and preclinical testing phases rather than enrolling human participants.

The types of products NIH is looking to advance include broadly neutralizing antibodies (bNAbs) and related derivatives, as well as other soluble, antibody-like molecules. In practical terms, this can encompass engineered antibodies and next-generation constructs built from antibody principles (for example, modified Fc regions, multispecific formats, antibody-drug conjugate-like concepts, or other engineered binding proteins) as long as the end product is intended to recognize HIV-infected cells with high specificity and induce their elimination while maintaining an acceptable safety profile. The emphasis on “late-stage engineering” signals that applicants are expected to have a credible starting candidate or platform and to propose work that meaningfully de-risks the product for eventual clinical translation, such as improving specificity, potency, manufacturability, stability, and preclinical safety.

The award mechanism is a UG3/UH3 cooperative agreement, which generally supports a phased approach: an initial stage focused on milestone-driven optimization and feasibility work, followed by a subsequent stage that expands into more advanced preclinical development once predefined milestones are met. Because this is a cooperative agreement, NIH staff typically have substantial scientific and programmatic involvement compared with a standard grant, often including active coordination around milestones, deliverables, and translational expectations. The overall activity category is health, and the associated CFDA number is 93.855.

Eligibility is broad and includes many standard U.S.-based applicant categories such as state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (outside of higher education institutions); for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are important limitations related to foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the prime applicant, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant may include certain foreign collaborators or elements when well-justified and consistent with NIH policy, even though the main applicant organization must be domestic.

Administratively, the sponsoring agency is the National Institutes of Health, and the original closing date listed for applications is March 13, 2024. The opportunity lists an award ceiling of $500,000. The posting date shown is October 25, 2023. The number of expected awards is not specified in the provided information, suggesting applicants should not assume a particular funding volume and should focus instead on strong alignment with the program’s translational, preclinical-development priorities and milestone-driven progression.

Overall, this NOFO is best suited for teams that already have a compelling biologic concept for eliminating HIV-infected cells and now need support to engineer it into a more developable candidate and to complete the key preclinical work that would set the stage for a future clinical program, while keeping all proposed activities strictly outside of human clinical trial execution under this funding announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Engineering and Preclinical Development of Biological Products that Eliminate HIV-infected Cells (UG3/UH3 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 2023-10-25.
• Applicants must submit their applications by 2024-03-13. (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 $500,000.00 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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