Funding Opportunity Number: PA-27-101
Application deadline: Tuesday, September 8, 2026 by 5:00pm local time of applicant organization
Overview
The National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award is a first-of-its-kind funding mechanism designed to accelerate late-stage clinical development of therapeutic and medical device technologies addressing pediatric and rare cancers. The program supports Phase II efficacy, registrational, and pivotal studies that can generate the clinical evidence needed to advance technologies toward regulatory approval, partnership, acquisition, or commercialization. A key feature of this award is its matching requirement. Applicants must secure third-party funding equal to 100% of the NIH funds requested, demonstrating meaningful commercial interest from outside investors or strategic partners.
Program Focus
Strategic Breakthrough Awards can support clinically promising therapeutic and medical device technologies that:
- Address pediatric and/or rare cancer indications (Applicants proposing rare cancer indications should align with the FDA Orphan Drug criteria of fewer than 200,000 affected individuals in the United States)
- Have demonstrated early clinical promise
- Are ready for Phase II efficacy, registrational, or pivotal studies
- Have potential to improve treatment outcomes where standard of care has seen limited progress
- Can leverage private-sector matching capital to accelerate clinical translation
Why Strategic Breakthrough?
Pediatric and rare cancers continue to represent areas of significant unmet medical need where standard of care has seen limited advancement. While many technologies demonstrate promising early clinical results, advancing programs through late-stage clinical development often requires resources beyond those available through traditional funding mechanisms. This is especially true for technologies targeting pediatric and rare cancer. Strategic Breakthrough Awards are intended to accelerate development of clinically promising technologies that have the potential to improve patient outcomes in these high-need populations.
Budget
Strategic Breakthrough Awards may provide up to $15 million in total funding over a four-year project period. Applicants should propose a four-year project and budget that appropriately distribute requested funds across the project period.
Eligibility
- U.S. small business concerns (SBCs), as defined by the Small Business Administration, are the only eligible applicants. Foreign organizations are not eligible.
- Applicants must have received a qualifying NIH SBIR or STTR Phase II award and should submit a Phase IIB Strategic Breakthrough application within the first six due dates following the expiration of the Phase II budget period. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project.
- Applicants must provide a commercialization plan demonstrating how the proposed work advances the project toward a marketable product or service.
- Applicants must demonstrate new third-party matching funds totaling at least 100% of the NIH funds requested over the full project period.
For more information on eligibility, please refer to Section III of the solicitation.
Third-Party Funding Requirement
The required matching funds are intended to encourage meaningful participation from investors, strategic partners, and other stakeholders who can help accelerate clinical translation and commercialization. Matching funds may include new private capital (e.g. another company, venture capital firm, or other private investor), new funding awarded by a government agency (other than a Phase I of II SBIR/STTR award), or a combination of these sources. Applicants must provide a commercialization plan that describes the long-term commercialization strategy and any independent third-party investor funding that has been secured or committed to support the proposed project.
Third-party funding can provide evidence of commercial interest and external validation; however, its significance depends on both the amount and the source of support. Reviewers will assess the extent to which the funding reflects meaningful market validation and advances the technology toward clinical development and commercialization.