Through the notice of funding opportunity (NOFO) Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed), NIAID will support the development of safe and effective long-acting/sustained release (LA/SR) technologies to help prevent and treat HIV and related co-infections such as tuberculosis (TB), hepatitis B (HBV), and hepatitis C (HCV). LA/SR technologies not only maintain consistent and effective drug levels for extended periods of time but also provide effective drug concentrations at reduced drug dosing intervals—thereby simplifying dosing requirements and helping reduce the life-long burden that HIV prevention and treatment approaches can have on patients.
Research Objectives and Research Plan Requirements
In your application, you should show a strong rationale, competitive advantage, and effectiveness in appropriate nonclinical or animal models at intermittent dosing from either a single administration (such as injection, topical, oral administration) or continuous dosing regimen (such as an implant or transdermal patch) with a minimum dosing interval of once every 3 months for HIV treatment or prevention or a minimum of once-a-month treatment for TB, HBV, or HCV.
Proposed LA/SR technologies may include small molecules, peptides, proteins, oligonucleotides, gene therapies, polymers, and contain a single or a combination of Active Pharmaceutical Ingredients or be used in combination with other agents, such as transporters, enzyme inhibitors, or immunomodulators, to improve their efficacy and prolong therapeutic effect.
Applicants must include (1) a Target Product Profile to summarize long-acting drug product critical properties and targets for development, (2) a defined investigational new drug (IND)-directed product development strategy in concordance with FDA guidance that addresses all IND components, (3) description of ownership and intellectual property (IP) rights for the proposed product to ensure freedom to operate, (4) a plan for a pre-IND meeting with the FDA by the end of the fourth year of funding, and (5) a timeline. Applicants must also define critical points within the timeline and establish a set of benchmarks throughout the entire program to monitor progress and to stay focused on program objectives towards filing the IND application.
In addition, applicants are required to identify an industry partner or translational advisor with an established record in product development as well as potential collaborators or consultants with specialized expertise.
If you propose the following research in your application, NIAID will consider it nonresponsive and not review it:
- Discovery and early product development work.
- LA/SR technologies for HIV and HIV-associated co-infections that do not meet the minimum dosing interval requirements as defined in the NOFO.
- Development of broadly neutralizing antibodies (bnAbs), non-neutralizing antibodies, bispecific or trispecific antibodies, or other engineered antibody-based approaches (e.g., molecules combining antibody domains with other non-antibody domains, such as CD4) as long-acting agents.
- Single agent prevention modalities that include advancement of Tenofovir or cabotegravir, including pro-drugs.
- Strategies for HIV, TB, HBV, or HCV vaccines for treatment or prevention, or PrEP strategies coupled to a vaccine.
- Clinical trials are not allowed, but use of samples from clinical trials supported elsewhere is allowed.
- Applications lacking the following components:
- Target Product Profile (TPP)
- Defined IND-directed product development strategy
- Description of ownership and IP rights for the proposed product
- Timeline and/or Gantt Chart
- Inclusion of an industry partner or translational advisor
- Plans for an External Advisory Board
- Milestones for the R61 Phase
- Clearly articulated plans for a pre-IND meeting
Due to the high-risk, high-impact nature of the research and the milestone-driven preclinical development activities, this funding opportunity will use the R61/R33 Exploratory/Developmental Phased award with investigator-provided milestones. Proposed milestones will be reviewed and negotiated prior to award.
Note that applications without milestones will not be reviewed.
Application Deadlines and Budget
Application budgets are not expected to exceed $700,000 in direct costs less consortium indirect (facilities & administrative) costs per year during the R61 Phase and $1,000,000 in direct costs less consortium indirect costs per year during the R33 Phase. Applicants may request up to 2 years of support for the R61 phase, and up to 3 years of support for the R33 Phase. It is expected that approximately half of the projects supported during the R61 Phase will continue into the R33 Phase.
The maximum project period for an application submitted in response to this NOFO cannot exceed 5 years total.
NIAID intends to fund three to five awards in fiscal year 2026.
Applications are due March 13, 2025, at 5 p.m. local time of the applicant organization. Send an optional letter of intent 30 days prior to the due date.
Contacts
For application questions please contact the following: HIV prevention contact Dr. Kristen A. Porter at kristen.porter@nih.gov or 301-761-7022 and for treatment of HIV, TB, HBV, HCV contact Dr. Marina Protopopova at marina.protopopova@nih.gov or 301-761-7653. Reach out to Dr. Shiv A. Prasad with peer review questions at shiv.prasad@nih.gov or 240-627-3219.