Non-Viral Technologies for in vivo Delivery of Genome Editors (R41/R42 Clinical Trial Not Allowed) | PAR 20 109

Opportunity Information: Apply for PAR 20 109

The National Institutes of Health (NIH) funding opportunity PAR-20-109, titled "Non-Viral Technologies for in vivo Delivery of Genome Editors (R41/R42 Clinical Trial Not Allowed)," is a Small Business Innovation Research (SBIR) grant program designed to move genome editing therapies closer to real-world medical use by improving how genome editors are delivered inside the body. The central focus is on non-viral delivery approaches, meaning the solicitation is aimed at technologies that can transport genome editing tools to target cells and tissues without relying on viral vectors. The program emphasizes delivery to disease-relevant somatic tissues in vivo, so the work is expected to address practical barriers to getting genome editors into the right organs or cell types with sufficient efficiency, acceptable biodistribution, and an appropriate safety profile. Although the immediate funding mechanism is for research and development, the long-term intent is clearly translational: the NIH is looking for delivery platforms that can ultimately support human clinical testing of genome editing as a treatment for disease.

This opportunity uses the SBIR phased grant structure, specifically the R41 (Phase I) and R42 (Phase II) mechanisms. In practical terms, Phase I typically supports early proof-of-concept work such as validating feasibility, demonstrating preliminary delivery performance, and generating foundational data that reduces technical risk. Phase II generally supports more advanced development, optimization, and expanded evaluation to strengthen the case that the technology is ready for later-stage translational work. Even though the end goal is eventual clinical translation, this particular announcement explicitly states "Clinical Trial Not Allowed," which means applicants should not propose human clinical trials under this solicitation. Instead, the work should stay within preclinical research and development, such as platform engineering, formulation work, in vivo animal studies, tissue targeting, dose-response testing, and other non-clinical evaluations that build a credible path toward a future investigational program.

Eligibility is restricted to U.S. small businesses, consistent with the SBIR program. Non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to be part of the application in the way that would constitute a non-domestic component. However, the announcement notes that "foreign components" (as defined in the NIH Grants Policy Statement) may be allowable in some cases, which typically refers to limited, well-justified elements of the project that take place outside the U.S. under specific NIH rules and approvals. In general, though, the applicant organization itself must be a U.S.-based small business, and the core of the work is expected to be performed domestically.

Administratively, the opportunity is categorized as a discretionary NIH grant in the health funding activity area (CFDA 93.350). The listing indicates it was created on February 6, 2020, with an original closing date of January 5, 2022. The publicly provided source data does not specify an award ceiling or the expected number of awards, which usually means prospective applicants would need to consult the full NIH notice and related SBIR budget guidelines to understand typical funding levels, project period limits, and other standard constraints. Overall, this program is aimed at helping small businesses develop practical, scalable, non-viral delivery technologies for genome editors that can reach clinically relevant tissues in living organisms, generate strong preclinical performance and safety-relevant data, and position those technologies for eventual entry into clinical testing through future, appropriate regulatory pathways and funding mechanisms.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Non-Viral Technologies for in vivo Delivery of Genome Editors (R41/R42 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
• This funding opportunity was created on 2020-02-06.
• Applicants must submit their applications by 2022-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 20 109

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