NIAID will fund research on late-stage engineering and preclinical development of innovative biological products that safely and specifically engage the immune system to kill HIV-infected cells through the notice of funding opportunity (NOFO) Engineering and Preclinical Development of Biological Products that Eliminate HIV-Infected Cells (UG3/UH3, Clinical Trial Not Allowed).
Consider applying if you work on products like broadly neutralizing antibodies, their derivatives, and other soluble, antibody-like molecules that bind to HIV-infected cells and recruit immune cells to specifically kill HIV-infected cells.
Phased Research Award
This NOFO uses the phased exploratory/development cooperative agreement (UG3/UH3) award mechanism because of the high-risk, high-impact nature of the research. The UG3 phase is meant for hypothesis- and milestone-driven basic technology research, assay development, generation of a pre-investigational new drug (IND) development plan, and completion of a meeting with FDA appropriate for the stage of product development. The UH3 phase is for pre-IND studies and additional activities, such as expanded assay development, optimization, proof-of-concept validation with human samples, and usability testing.
Study Requirements
Your application must propose the following:
- Preclinical work to advance late-stage development of biologics engineered to kill HIV-infected cells.
- IND-enabling, preclinical studies according to Good Laboratory Practice using product from the engineering run of product scale-up following FDA-defined current Good Manufacturing Practice (cGMP).
- Tissue cross reactivity studies and possibly a binding study against an array of human membrane bound and secreted proteins to identify the appropriate species for the toxicology studies.
- Toxicology studies to evaluate animal PK and to identify the no observed adverse effect level and potential safety concerns.
- Confirmatory proof-of-concept studies with human samples or in an appropriate animal model.
- Continued assay development to comply with FDA guidance.
- Milestones for transitioning from the UG3 phase to the UH3 phase.
This initiative aims to advance laboratory-scale product candidates to cGMP material ready for human clinical trials. As such, your application must include at least one private sector entity with commitment to contribute materially and intellectually to the overall goals and objectives of the project.
The NOFO also lists application elements that you must or must not include for NIAID to assess your application as responsive. For example, you must not propose a clinical trial, and your application must include a milestone section. Refer to the NOFO linked above for complete lists of required and disallowed elements.
Also, find details in the NOFO describing how each awarded investigator will participate in a steering committee and form a scientific advisory board.
Administrative Requirements
Your application budget should not exceed $500,000 in annual direct costs for the UG3 phase. Similarly, it should not exceed $750,000 in annual direct costs for the UH3 phase. Keep in mind, your requested budget needs to reflect the actual needs of the proposed project.
As for your project period, the UG3 phase may last from 1 to 3 years. The UH3 phase may last from 2 to 4 years. The total project period, inclusive of both the UG3 and UH3 phases, cannot exceed 5 years.
The deadline to apply is March 13, 2024, at 5 p.m. local time of the applicant organization.
Direct questions about this NOFO to Dr. Stephen Smiley at stephen.smiley@nih.gov or 240-267-3071 and Dr. Yan Zhou at zhouy16@niaid.nih.gov or 240-485-9785. For inquiries specific to peer review, instead contact Dr. J. Bruce Sundstrom at sundstromj@niaid.nih.gov or 240-669-5054.