Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed) | RFA AI 24 076

Opportunity Information: Apply for RFA AI 24 076

The Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) funding opportunity (RFA-AI-24-076) is a National Institutes of Health (NIH) discretionary grant program designed to move promising long-acting and sustained-release (LA/SR) drug or delivery approaches closer to real-world clinical development. The central goal is to fund preclinical work that strengthens the safety, performance, and translational readiness of LA/SR technologies aimed at preventing or treating HIV and key HIV-associated co-infections: tuberculosis (TB), hepatitis B (HBV), and hepatitis C (HCV). The emphasis is not on running human studies, but on generating the kinds of nonclinical evidence packages that position a product for an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA).

Projects are expected to focus on LA/SR products with a strong scientific rationale and a clear competitive advantage over existing options, such as improvements in dosing frequency, adherence, durability of drug exposure, tolerability, or practicality of delivery. The NOFO is aimed at candidates that have already shown effectiveness in relevant nonclinical or animal models and that can plausibly demonstrate meaningful benefit when dosed intermittently (for example, via a single injection, topical application, or oral administration given at extended intervals) or through continuous delivery platforms (such as implants or transdermal patches). In other words, applicants should be prepared to show they are beyond early concept work and are building toward a credible translational path that culminates in IND-enabling readiness.

Because this opportunity is framed around translation to IND, the supported activities are expected to be the kinds of preclinical steps that reduce risk and answer regulator-relevant questions. While the notice text provided does not enumerate specific required experiments, the intent typically aligns with work such as formulation optimization for long-duration release, dose and exposure justification, pharmacokinetics and pharmacodynamics appropriate to extended dosing intervals, biodistribution considerations for delivery systems, and nonclinical safety and tolerability packages that support advancement toward FDA filing. The NOFO also makes clear that clinical trials are not allowed under this mechanism, so the funded scope should remain in the preclinical and preparatory translational space rather than human efficacy or safety testing.

The mechanism listed in the title is R61/R33, which commonly signals a phased approach used by NIH to support milestone-driven development: an initial phase that helps establish feasibility and complete key early translational tasks, followed by a subsequent phase that supports more advanced development once predefined milestones are met. Applicants should read that structure as a signal that funders will be looking for a tightly planned progression with measurable go/no-go criteria, rather than open-ended exploratory research.

Eligibility is broad and includes a wide range of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special district governments; 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; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights additional eligible applicant types, including 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, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-domestic (non-U.S.) entities.

Administratively, this is a grant (funding instrument type: Grant) in the health category, associated with CFDA number 93.855. The original closing date listed is March 13, 2025, and the opportunity was created on November 22, 2024. The award ceiling and expected number of awards are not specified in the provided source text, so applicants would need to consult the full NOFO for budget limits, project period expectations, review criteria, and any required milestones or product development plan elements.

In practical terms, this opportunity is best suited for teams with a credible LA/SR candidate or platform already supported by persuasive nonclinical data, who can articulate why their approach is meaningfully better than standard dosing and who can map a clear preclinical development plan toward IND submission for HIV and/or HIV-linked co-infections. The program is explicitly aimed at shortening the distance between strong preclinical proof-of-concept and regulator-ready development, while keeping all funded work in the nonclinical domain.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 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 2024-11-22.
• Applicants must submit their applications by 2025-03-13. (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.

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