Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed) | RFA AI 24 013

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The NIH funding opportunity "Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed)" (RFA-AI-24-013) is designed to build coordinated, multi-project research programs that push gene- and cell-based HIV cure strategies forward from discovery into robust preclinical readiness. The central focus is on developing, characterizing, and advancing interventions intended to achieve long-term HIV remission or complete elimination of the virus. While the work supported under this announcement is not allowed to include clinical trials, the expectation is that the proposed approaches are being developed with a clear line of sight to eventual clinical evaluation, including practical considerations around scalability, manufacturing, and real-world deliverability.

This opportunity uses the NIH P01 mechanism, which is meant for larger, integrated programs made up of multiple related projects that share an overall scientific theme and are structured to achieve goals that would be difficult to accomplish through separate, independent grants. In practical terms, an application would typically combine complementary projects that may span foundational biology (for example, understanding viral persistence or immune mechanisms relevant to cure), technology development (such as engineering gene-editing tools, vectors, or cellular products), and translational preclinical testing. The NOFO explicitly anticipates a mix of basic science discovery and preclinical research, including test-of-concept studies in animal models. The emphasis on a "pipeline" signals that reviewers will likely look for a coherent progression: ideas and tools emerging from discovery work should feed into optimization, safety and performance characterization, and then into rigorous preclinical proof-of-concept packages that position the program for later clinical entry under future funding or partnerships.

A defining requirement is the inclusion of one or more private sector partners as active participants in the overall program. This requirement aligns with the NOFO's emphasis on eventual clinical translation and scalability, since industry partners often bring expertise in manufacturability, platform development, quality systems, regulatory planning, and commercialization pathways. Applicants should therefore expect to describe how the private sector partner(s) will contribute in a substantive way, not merely through letters of support, and how the partnership will accelerate translation, standardization, and readiness for later-stage development. This also implies that the program should pay attention to practical issues that often slow cell and gene therapy translation, such as reproducible product characterization, dose and potency metrics, delivery approaches, and feasibility of scaling processes.

The eligible applicant pool is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city or township 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; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education where relevant); for-profit organizations other than small businesses; and small businesses, along with other categories NIH may allow. The NOFO also highlights eligibility for organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and U.S. territories or possessions.

On the foreign eligibility side, the announcement draws an important distinction. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible to be included, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed. In other words, the lead applicant must be a domestic eligible organization, but the proposed research program may incorporate international elements when appropriately justified and structured under NIH rules.

Administratively, this is a discretionary NIH grant opportunity in the health category, associated with CFDA numbers 93.233, 93.242, 93.837, 93.838, 93.839, 93.840, and 93.855. The original closing date listed is July 30, 2024, and the NOFO was created on April 8, 2024. While the provided excerpt does not specify an award ceiling or the expected number of awards, applicants would normally look to the full NOFO text for budget limits, project period expectations, required program structure (for example, cores and administrative components typical of P01s), and any special review criteria tied to HIV cure gene and cell therapy development.

Overall, the opportunity is aimed at teams that can integrate multiple disciplines into a single programmatic plan: mechanistic HIV cure science, engineering and product development for gene and cell therapies, and rigorous preclinical evaluation that meaningfully de-risks the approach for future clinical testing. The requirement for private sector participation and the repeated emphasis on scalability and deliverability make it clear that NIH is looking not only for scientific novelty, but also for well-planned translational execution that can realistically feed a longer-term clinical pipeline.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 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): 93.233, 93.242, 93.837, 93.838, 93.839, 93.840, 93.855.
• This funding opportunity was created on 2024-04-08.
• Applicants must submit their applications by 2024-07-30. (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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