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

The National Institute of Allergy and Infectious Diseases (NIAID) seeks applications under the Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) funding opportunity, designed to support preclinical research for developing long-acting/sustained release (LA/SR) technologies. These innovations target prevention and treatment of HIV and associated co-infections, including tuberculosis (TB), hepatitis B (HBV), and hepatitis C (HCV). The program aims to facilitate investigational new drug (IND) applications and clinical trial readiness by advancing LA/SR products that demonstrate safety, efficacy, and competitive advantages in intermittent dosing regimens. This funding opportunity emphasizes technologies that reduce treatment frequency, improve adherence, and enhance treatment outcomes for PLWH and co-infections. Supported projects will focus on LA/SR systems delivering effective drug concentrations at minimum dosing intervals of three months for HIV and one month for TB, HBV, or HCV. Eligible approaches include small molecules, peptides, proteins, oligonucleotides, polymers, or gene therapies with strong preclinical evidence of feasibility and effectiveness. Examples include implantable devices, transdermal patches, and injectables, as well as multipurpose prevention technologies (MPTs) for combined health benefits. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government agencies, and foreign entities. Collaboration with industry partners or translational advisors is required to ensure successful product development. Additional mandatory elements include a Target Product Profile (TPP), a detailed IND-directed product development strategy, intellectual property documentation, defined milestones for the R61 phase, and plans for an Expert Advisory Board. Applications proposing vaccines, antibodies, or agents with insufficient dosing intervals, or lacking these required components, will not be reviewed. The R61/R33 Exploratory/Developmental Phased Award mechanism will fund milestone-driven projects, providing up to $700,000 in direct costs annually during the R61 phase (up to two years) and $1,000,000 annually during the R33 phase (up to three years). NIAID expects to fund 3-5 awards with a total FY 2026 budget of $4 million. Transition to the R33 phase depends on achieving R61 milestones, programmatic priorities, and fund availability. Applications must be submitted electronically through NIH's ASSIST system or Grants.gov by March 13, 2025. Letters of intent are encouraged but not required. Key requirements include a Gantt chart for project timelines, a plan for pre-IND meetings with the FDA, and collaborations with Contract Research Organizations (CROs) or other experts. The proposal will be evaluated on scientific rigor, feasibility, innovation, investigator expertise, and alignment with program priorities. This funding opportunity supports the development of innovative LA/SR strategies with the potential to transform HIV and co-infection management globally. By emphasizing preclinical advancement toward IND applications, the program aims to bridge critical gaps between research and clinical implementation, fostering next-generation solutions for improved global health outcomes.