Simpler Grants.gov #RFA-NS-28-012

NIH funding for translational genomic and biologic therapies for ADRD

The National Institutes of Health is funding translational research to advance genome-editing and other biologic therapies for Alzheimer’s disease-related dementias (ADRD). - Government buyer: U.S. Department of Health and Human Services, National Institutes of Health (NIH), led by the National Institute of Neurological Disorders and Stroke (NINDS), with participation from the National Institute on Aging (NIA). - Opportunity: RFA-NS-28-012, “Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional).” - Requested work: Milestone-driven development of genome-editing and other biologic therapies, potentially including therapeutic and delivery-system optimization; in vitro and in vivo efficacy studies; dose-ranging, pharmacokinetics/pharmacodynamics, target engagement, biodistribution, and durability assessments; assay development; scalable manufacturing and formulation; regulatory preparation and IND-enabling work; and justified early-phase human studies. - Funding: NIH anticipates up to three awards per funding year and plans $6 million in total funding annually, subject to appropriations and meritorious applications. Annual direct-cost budgets are generally capped at $1.3 million; applications that include a Phase 1 first-in-human clinical trial may request up to $2.5 million per year. - Notable requirements: Applicants are expected to propose annual quantitative milestones and explicit Go/No-Go criteria. Projects may include a clinical trial when justified. - OEMs and vendors: No commercial manufacturers, OEMs, or vendors are identified.

Description

This Notice of Funding Opportunity supports translation of genome editing and other biologic therapies for Alzheimer's Disease-Related Dementias. The scope spans therapeutic lead optimization and drug product development through IND-enabling studies and early clinical evaluation, including optimization of editing constructs and delivery systems, efficacy and safety studies, and scalable manufacturing development. The opportunity is issued as a cooperative agreement, with up to three awards anticipated each year. The maximum award budget is $2,500,000 in direct costs per year for applications including clinical trials; otherwise, the stated annual budget limit is $1,300,000 in direct costs.

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