Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required)
ID: 357306Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357306

Additional Information

http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-24-008.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for competitive revisions to support clinical trials in somatic cell genome editing, specifically under the funding opportunity RFA-RM-24-008. This initiative aims to expand the existing Somatic Cell Genome Editing program by soliciting applications from awardees with active U19 awards funded under RFA-RM-22-015, which previously did not allow clinical trials. The funding will facilitate first-in-human genome editing clinical trials, including essential preparatory activities such as patient recruitment, regulatory approvals, and the development of clinical trial designs. Interested applicants must submit their proposals by February 13, 2026, and can find additional information and submission guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    RFA-RM-24-008.html
    The Department of Health and Human Services, through the NIH, has issued a Notice of Funding Opportunity (NOFO) aimed at expanding the existing Somatic Cell Genome Editing (SCGE) program. This initiative seeks applications for competitive revisions under funding opportunity RFA-RM-24-008, focusing on clinical trials for therapeutics developed under prior awards (RFA-RM-22-015) that did not initially permit clinical trials. The current funding will support first-in-human genome editing clinical trials, including necessary preparatory activities like patient recruitment and regulatory approvals. Key activities encompass developing clinical trial designs, manufacturing materials, and preparing IND applications, with a focus on health disparities and community engagement. The program emphasizes collaboration among awardees, NIH staff, and community partners to optimize and demonstrate efficacious genome editing therapeutics. With an anticipated budget contingent on existing awards and an emphasis on rigorous scientific merit, the NOFO establishes clear eligibility criteria, review processes, and milestones for assessing progress. Applications are due by specific dates and must adhere to detailed submission guidelines and regulations. This effort aims to drive forward the therapeutic application of genome editing, addressing critical barriers to treatment for genetic diseases.
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