Key Dates

Related Announcements

• June 2, 2022 - PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed).  See NOFO PA-22-178
• June 2, 2022 - PHS 2022-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed).  See NOFO PA-22-176
• May 5, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed).  See NOFO PA-20-195

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice of Special Interest (NOSI) invites applications focused on the preclinical discovery, evaluation and development of oral direct-acting small molecule therapeutics targeting selected viruses of pandemic potential. The ultimate goal of this NOSI is to build a more robust pipeline of candidate antiviral drugs suitable for widespread use in the community in future outbreaks and/or pandemics.

Background

Typical drug discovery programs require several years to progress through initial lead series identification and optimization to selection of a candidate drug for clinical trials. Availability of a broader range of antiviral compounds may help shorten the time needed to identify promising lead drug candidates when unexpected outbreaks arise. This NOSI builds on the  Antiviral Program for Pandemics , which was launched in 2021 with funding from the American Rescue Plan.

Research Objectives

The objective of this NOSI is to support the discovery and development of small molecule compounds (MW < 2 kDa) with activity against viral targets that can be administered orally as monotherapy or in combination with other drugs to treat infections caused by viruses of pandemic potential. Activities are anticipated to range from early discovery and optimization of lead series with activity against a specific pathogen or viral family, to late-stage preclinical development and IND-enabling profiling of specific drug candidates. Collaboration with pharma to access chemical starting points and critical medicinal chemistry, regulatory and drug development expertise is strongly encouraged. Applications should include multidisciplinary activities appropriate to the project’s stage of discovery and development. Areas of interest include but are not limited to:

• structure-based design and medicinal chemistry
• biochemical screening
• in vitro efficacy
• in vivo efficacy
• mechanism of action studies
• pharmacology and toxicology

Applications focused on antiviral research on viruses from one or more viral pathogens from the following RNA virus families of pandemic potential are in scope of the NOSI:

• Coronaviruses (activity against multiple coronaviruses, ‘pan-CoV’, required)
• Paramyxoviruses
• Bunyaviruses (Bunyavirales order)
• Togaviruses
• Filoviruses
• Picornaviruses
• Flaviviruses
• Orthomyxoviruses

Applications proposing any of the following will NOT be supported under this NOSI:

• Approaches that target the host and not the virus.
• Therapeutics that will require intravenous, intranasal or other non-oral delivery routes.
• Antibody or other non-small molecule approaches in which the candidate’s MW exceeds 2 kDa,
• Efforts to repurpose or reformulate marketed drugs.
• Products that target viruses other than Coronaviruses, Paramyxoviruses, Bunyaviruses (Bunyavirales order), Togaviruses, Filoviruses, Picornaviruses, Flaviviruses, or Orthomyxoviruses or that only have narrow-spectrum anti-coronavirus (e.g., SARS-CoV-2 only) activity.

Application and Submission Information

This notice applies to application receipt dates on or after October 5, 2024, and subsequent receipt dates through July 16, 2027.

Submit applications for this initiative using one of the following funding opportunity announcements (NOFOs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-185 – NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-195 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-22-178 – PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-22-176 – PHS 2022-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AI-24-053” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Mindy Davis, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Microbiology and Infectious Diseases
Virology Branch
Telephone: 301-761-6689
Email: mindy.davis@nih.gov

Dipanwita Basu, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Division of Microbiology and Infectious Diseases
Respiratory Diseases Branch
Telephone: 240-627-3469
Email: dipanwita.basu@nih.gov

Financial/Grants Management Contact(s)

Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: khuranav@niaid.nih.gov