Toward Translation of Nanotechnology Cancer Interventions (TTNCI; R01 Clinical Trial Not Allowed)

The National Cancer Institute (NCI) has announced the funding opportunity PAR-25-336, titled *“Toward Translation of Nanotechnology Cancer Interventions (TTNCI; R01 Clinical Trial Not Allowed).”* This initiative seeks to support advanced preclinical research to enable the translation of nanotechnology-based cancer diagnostics and therapeutics. The goal is to mature nanotechnology-based interventions, such as nanoparticle formulations or nano-devices, designed for clinically relevant cancer objectives with the potential to improve cancer diagnosis and treatment outcomes. The TTNCI program emphasizes translational readiness, requiring projects to align with clinical objectives rather than focusing solely on nanotechnology innovation. Successful outcomes are expected to prepare projects for entry into programs such as the NCI Experimental Therapeutics (NExT) initiative. Research supported under this opportunity should focus on one or more of three priority areas: combination therapy, immunotherapy, or imaging and diagnostics. Examples of relevant research include the delivery of synergistic active pharmaceutical ingredients (APIs) via nanoparticles, immune response modulation, or development of theranostic agents combining diagnostic and therapeutic functions. Projects must demonstrate strong preclinical evidence of effectiveness and include detailed milestones to track progress. Research should incorporate multidisciplinary collaboration, with leadership that includes clinical expertise. Proposals involving nanoparticles or nano-devices already in clinical trials must present a novel cancer indication or approach. Eligible applicants include higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations, small businesses, state and local governments, tribal organizations, and public housing authorities. Non-domestic (non-U.S.) entities are not eligible, although foreign components of U.S. organizations are permitted. All applicants must meet registration requirements with SAM.gov, eRA Commons, and Grants.gov. Each project’s budget is limited to $475,000 in direct costs per year, with a maximum project period of four years. Applications must include a research strategy addressing significance, innovation, and approach, along with defined milestones to measure annual progress. Projects must focus on one or two specific tumor types, supported by evidence from preclinical models or human samples. Collaborations with NCI’s Nanotechnology Characterization Laboratory (NCL) are encouraged, and data sharing through the Cancer Nanotechnology Laboratory data portal (caNanoLab) is required. Applications will be evaluated based on their significance, innovation, rigor, feasibility, and expertise of investigators. Additional considerations include protections for human subjects, animal welfare, and biohazard safety. Milestones will be carefully reviewed to ensure measurable progress toward clinical translation. Awards will be determined based on scientific merit, program priorities, and availability of funds. The first application due date is May 19, 2025, with subsequent dates semi-annually until November 15, 2027. Applicants are encouraged to apply early to resolve potential submission issues. Technical support for submission is available through NIH’s eRA Service Desk, Grants.gov, and NCI program staff.