SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional) | RFA CA 22 025

Opportunity Information: Apply for RFA CA 22 025

The SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional), funding opportunity number RFA-CA-22-025, is a National Institutes of Health program (through the National Cancer Institute) designed to help small businesses push promising cancer-related technologies past the SBIR/STTR Phase II stage and into real-world commercialization. It specifically targets projects that already received a Phase II SBIR or STTR award from any federal agency and now need additional resources to complete the next, often more expensive, development steps that stand between an advanced prototype or validated approach and a market-ready product or service. In practice, this FOA is meant to bridge the so-called "valley of death" where technologies can stall due to the high cost of late-stage development, scaling, regulatory work, clinical evaluation, manufacturing readiness, or market preparation.

A central theme of this opportunity is leveraging outside capital and partnerships. The program is structured to encourage (and effectively require) meaningful engagement from independent third-party investors and/or strategic partners, such as venture investors, corporate partners, foundations, or other non-federal sources that can help carry the technology forward. Applicants must submit a Commercialization Plan that lays out a credible path to market and clearly explains the status of third-party support. This includes detailing investor or partner funding that has already been secured or that is realistically expected during the Phase IIB project period. The FOA sets a strong expectation that the amount of independent third-party funding will be equal to or greater than the amount of NCI funding requested over the entire Phase IIB Bridge Award period, reinforcing the idea that NCI funds are intended to catalyze and de-risk a product on a trajectory that the private or non-federal sector is also willing to back.

The scope of work can span both preclinical and clinical development, depending on what is appropriate for the technology and its maturity. That means projects may focus on advanced preclinical milestones (for example, optimization, validation in relevant models, manufacturing process development, analytical validation, quality systems, or regulatory preparation) and/or clinical-stage work. Clinical trials are explicitly allowed under this announcement but are not mandatory, making the program flexible for technologies that are not yet ready for a trial or that require additional preclinical evidence, design finalization, or regulatory groundwork before entering human studies. The mechanism is R44 (SBIR), and it is labeled "Clinical Trial Optional," signaling that proposed clinical evaluation is acceptable when justified but not a requirement for competitiveness on its own.

Eligibility is limited to small business concerns, consistent with SBIR rules. Foreign institutions (non-U.S. entities) cannot apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components may be permitted in certain circumstances as defined under the NIH Grants Policy Statement, meaning a U.S.-based small business could potentially include some foreign work as a component if it meets NIH policy requirements and is justified, but the applicant organization itself must be eligible and U.S.-based.

From the funding details provided, the opportunity falls under discretionary grant funding, with activity categories listed under education and health and CFDA numbers 93.394 and 93.395. The award ceiling is listed as $2,000,000, indicating the maximum amount that can be requested under the FOA (subject to the full FOA terms, budget structure, and project period expectations). The original closing date shown is 2022-08-05, and the creation date is 2022-04-05. Overall, the program is best understood as a commercialization-focused extension for strong Phase II projects: it is not meant for early feasibility concepts, but for technologies that have already demonstrated enough progress to attract non-federal backing and that need a final, well-planned push to reach commercialization-ready milestones in the cancer space.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
• This funding opportunity was created on 2022-04-05.
• Applicants must submit their applications by 2022-08-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,000,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA CA 22 025

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