Key Dates

Related Announcements

• April 08, 2024 - Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed). See NOFO RFA-AI-24-013.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to inform potential applicants of an update to the Research Objective and Scope, a correction to the NIMH budget information and a clarification to the Non-Responsive applications in the Notice of Funding Opportunity (NOFO) RFA-AI-24-013,  Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed).

The following sections of RFA-AI-24-013 are being updated:

Currently Reads:

Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Research Objective and Scope

The goal of this notice of funding opportunity (NOFO) is to support integrated multi-project research programs to apply emerging and improved technologies, alone or in combination, to the development of innovative gene- and/or cell-based HIV cure approaches, defined as either sustained viral remission in the absence of antiretroviral treatment or elimination of HIV infection from the body. Applicants should leverage recent insights into virus-host interactions, genotype and phenotype of HIV latent cells, and reservoir cell survival and proliferation. Private sector partnerships are required to facilitate development of strategies appropriate for clinical studies and ultimately commercialization, if proven to be safe and effective.

Additionally, applications that do not include the following will be considered non-responsive and will not be reviewed.

• A private sector partner
• A Milestone Plan
• A plan for an INTERACT meeting with the FDA in the Milestone Plan
• The required number of projects

Section II. Award Information
Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2025:

NIAID, $6.5 million; NHLBI, $6.5 million; NIMH, $0.25 million; for a total of 3-4 awards

Modified to Read (changes shown in bold italics) :

Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Research Objective and Scope

The goal of this notice of funding opportunity (NOFO) is to support integrated multi-project research programs to apply emerging and improved technologies, alone or in combination, to the development of innovative gene- and/or cell-based HIV cure approaches, defined as either sustained viral remission in the absence of antiretroviral treatment or elimination of HIV infection from the body. Applicants should leverage recent insights into virus-host interactions, genotype and phenotype of HIV latent cells, and reservoir cell survival and proliferation. Private sector partnerships are required to facilitate development of strategies appropriate for future clinical studies and ultimately commercialization, if proven to be safe and effective.

Additionally, applications that do not include the following will be considered non-responsive and will not be reviewed.

• A private sector partner
• A Milestone Plan
• The required number of projects.

Section II. Award Information
Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2025:

NIAID, $6.5 million; NHLBI, $6.5 million; NIMH, $0.50 million; for a total of 3-4 awards

All other aspects of the NOFO remain unchanged.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Betty Poon, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID) 
Telephone: 240-669-5024
Email: poonb@mail.nih.gov

Lisbeth A Welniak, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI) 
Telephone: 301-827-8297
E-mail: welniakla@nhlbi.nih.gov

Jeymohan Joseph, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3869
Email: jjeymoha@mail.nih.gov