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Engineering and Preclinical Development of Biological Products that Eliminate HIV-infected Cells (UG3/UH3 Clinical Trial Not Allowed)

HHS-NIH11

Status:

Active

October 25, 2023

Posted:

Deadline: 

March 13, 2024

Funding

Program:

Award Floor:

Ceiling:

500000

Match Required?

No

Eligibility

All

States:

Entity Types:

State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed

Contact

Email:

Phone:

Source Type:

Federal

The purpose of this Notice of Funding Opportunity (NOFO) is to support the late-stage engineering and preclinical development of innovative biological products that safely and specifically kill HIV-infected cells. Products of interest include but are not limited to broadly neutralizing antibodies (bNAbs), their derivatives, and other soluble, antibody-like molecules. Broadly neutralizing antibodies (bNAbs) were initially selected for their potency and breadth of neutralization against a representative panel of pseudoviruses. Since then, bNAbs have been engineered to enhance their potency, breadth of neutralization, pharmacokinetics (PK), and manufacturability. Clinical trials have established that bNAb administrations are safe, and they can prevent infection and maintain viral suppression in individuals with bNAb sensitive viruses. However, they have not demonstrated sufficient killing of HIV-infected cells to significantly reduce the HIV reservoir or increase the proportion of individuals able to maintain viral suppression off antiretroviral therapy once bNAb levels have waned. The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) and other funding organizations have supported research to identify biologics that more effectively kill HIV- and other virus-infected cells, including molecules with Fc modifications and engineered antibodies and antibody-like molecules. However, few of these enhanced biologics have been tested in people with HIV. Two DAIDS/NIH sponsored workshops in 2022 identified the lack of funding for late-stage development and investigational new drug (IND)-enabling studies as a significant impediment to advancing these agents to the clinic.

Research Objectives and Scope
The purpose of this Notice of Funding Opportunity (NOFO) announcement is to support the late-stage engineering and preclinical development of innovative biological products that safely and specifically engage the immune system to kill HIV-infected cells. Products of interest include but are not limited to bNAbs, their derivatives, and other soluble, antibody-like molecules that tag HIV-infected cells and recruit immune cells to specifically kill HIV-infected cells.

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