Notice of Intent to Publish a Notice of Funding Opportunity for Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01 Clinical Trial Not Allowed)

Key Dates

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National Institute of Allergy and Infectious Diseases (NIAID)

This Notice is to inform potential applicants of the National Institute of Allergy and Infectious Diseases (NIAID) intent to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the development, characterization, and advancement of gene- and cell-based approaches to achieve long-term remission or elimination of HIV.

This Notice is being provided to allow potential applicants additional time to develop meaningful collaborations, interdisciplinary teams, and responsive applications.

The NOFO is expected to be published in April 2024 with an expected application due date in July 2024.

This NOFO will utilize the P01 (Research Program Projects) activity code. Details of the planned NOFO are provided below.

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. Recent advances in genome editing technologies, cell therapies, novel delivery approaches, and new strategies for product manufacturing can be applied to effectively target the underlying HIV-associated viral and immune pathologies, reconstitute protective, antiviral immunity, and achieve viral suppression or elimination of persistent HIV reservoirs.

Among the areas of research encouraged in this initiative are: 

• Strategies to apply advanced novel genome engineering technologies to target HIV provirus DNA or RNA.
• Cell- or tissue-targeting methods to enable in vivo delivery of gene therapies.
• Development of allogeneic or universal “off the shelf” cell and gene therapeutics.
• Approaches to modulate immune responses that impact therapeutic efficacy and dosing.
• Ex vivo or in vivo gene modification to render cells resistant to infection and/or enhance the immune system's ability to suppress viral expression or to eliminate HIV- infected cells.
• Novel methods to enhance transplantation and engraftment, or minimize rejection, of modified cells as part of an HIV-targeted transplantation strategy. 

Applications are expected to include basic science discovery as well as preclinical research activities such as test-of-concept studies in animal models. Each application will include at least one private sector partner that contributes materially and intellectually to facilitate development of strategies appropriate for future clinical studies and ultimately commercialization, if proven to be safe and effective. Each application will also provide a Milestone Plan and identify significant research outcomes, with timelines. The milestones should include plans for an INTERACT meeting with the FDA early in product development.

Further details will be included in the forthcoming NOFO.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

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