Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional) | RFA DA 25 022

Opportunity Information: Apply for RFA DA 25 022

Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity focused on creating or significantly improving delivery technologies that can move therapeutic or research cargo to the right place in the body, at the right time, and at effective levels. The central theme is delivery: the funding is aimed at work that makes it more feasible to use pharmacological agents, gene editing tools, or other biological or chemical payloads in studies related to HIV and substance use disorders (SUD), either to uncover mechanisms (mechanistic research) or to advance treatment strategies (therapeutic research). The grant uses the NIH R01 mechanism, which typically supports substantial, multi-year research projects, and it is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component if it is appropriate for the technology and aims, but they are not required to do so.

The scientific intent is to address common bottlenecks that slow down progress in HIV and SUD research: many promising drugs, biologics, nucleic acids, vectors, gene editors, or other payloads fail or underperform because they cannot be delivered efficiently, safely, or specifically to relevant tissues and cell types. This opportunity targets technology development that can overcome those barriers, such as improving targeting, crossing biological barriers, enhancing uptake into difficult-to-reach cells, controlling where and when the cargo is released, and reducing off-target distribution or toxicity. While the notice does not list specific platforms, the scope naturally includes a wide range of delivery approaches, including but not limited to engineered nanoparticles, viral and non-viral vectors, cell-based delivery, depot and long-acting formulations, tissue-targeting ligands, responsive or triggerable release systems, and methods to improve delivery to challenging anatomical compartments that matter for HIV or SUD research.

The opportunity is identified as Funding Opportunity Number RFA-DA-25-022, administered by NIH, with an activity category spanning education and health and a CFDA listing of 93.279. It is a grant (not a contract), and it falls under the "Discretionary" opportunity category. The stated original closing date is 2024-11-15, and the opportunity record was created on 2023-11-01. The listing does not provide an award ceiling or expected number of awards in the excerpt provided, so applicants would typically confirm budget limits, project period expectations, and review considerations in the full announcement text on NIH/Grants.gov.

Eligibility is broad and includes many types of U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. In addition, the opportunity explicitly highlights other eligible applicant categories 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); Indian/Native American tribal governments other than federally recognized entities; eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; regional organizations; and non-domestic (non-U.S.) entities, meaning foreign organizations can apply if permitted under NIH rules and the specific FOA.

In practical terms, a competitive application under this program would be expected to make a clear case that the proposed delivery technology solves a meaningful problem in HIV and/or SUD research and that it can be demonstrated through rigorous experiments, performance metrics, and validation plans. Projects generally need to define what cargo is being delivered (for example, a small molecule, biologic, nucleic acid, or gene editor), where it needs to go (specific tissues, organs, or cell types relevant to HIV or SUD), what delivery barriers are being addressed (stability, targeting, penetration, immune clearance, endosomal escape, long-acting exposure, and so on), and how success will be measured (delivery efficiency, functional activity of the cargo, durability, safety, specificity, manufacturability, or translational feasibility). Because the FOA allows clinical trials but does not require them, the work could range from early-stage technology development and preclinical validation to, where justified, clinical evaluation tied directly to the delivery innovation.

Overall, this R01 opportunity is designed to accelerate the development of enabling delivery technologies that can unlock new HIV and SUD mechanistic studies and therapeutic approaches, with broad organizational eligibility and flexibility in whether clinical trials are included.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2023-11-01.
• Applicants must submit their applications by 2024-11-15. (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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