Data / Federal grants / FOR-FD-26-004
Novel approaches to support therapeutic development in ultra-rare cancers
Food and Drug Administration (Department of Health and Human Services) expects to post this opportunity. It lists 2 awards expected.
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Key facts
- Opportunity number
- FOR-FD-26-004
- Status
- Forecast
- Posted
- August 4, 2025
- Expected awards
- 2
- Cost sharing
- Not required
- Funding instrument
- Cooperative Agreement
- Category
- Agriculture, Consumer Protection, Food and Nutrition
- Assistance listing
- 93.103 Food and Drug Administration Research
- Contact
- Patrick Johnson Grants Management Specialist · [email protected] · 301-796-0154
Who can apply
- County governments
- Independent school districts
- City or township governments
- Private institutions of higher education
- State governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- Public and State controlled institutions of higher education
- Public housing authorities/Indian housing authorities
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- Small businesses
- Special district governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
What the agency says
The purpose of this program is to support new approaches that can be applied to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers.
Specific areas of interest include, but are not limited to, the following examples: • Development of infrastructure for a coordination network and data repository for patient-level data across institutions and internationally to support drug development and regulatory decision-making for one or more ultra-rare cancers. • Investigations to explore opportunities to develop and validate early clinical endpoints and other novel efficacy endpoints for evaluation of treatments for ultra-rare cancers. • Development and implementation of a collaborative multi-stakeholder effort to support generation and use of real-world data leveraging a registry framework for use in development of new therapies for pediatric patients with diffuse midline glioma (DMG) (including diffuse intrinsic pontine glioma, DIPG). • Innovative approaches to identify new biologically-driven opportunities for clinical development of previously approved drugs or biologics (hereafter referred to as drugs), including drugs for which development has been discontinued, in ultra-rare cancers. • Research to develop novel approaches to preserve the availability of drugs for which commercial developers have discontinued adult development that have strong potential in ultra-rare cancers but lack financial incentives for commercial development • Development of methods to incorporate use of telemedicine and/or pragmatic trial design elements (e.g., collecting laboratory and/or imaging data from local facilities) for patient assessments to facilitate enrollment of patients with ultra-rare cancers • Development of nanoparticle-based delivery approaches for therapeutic nucleic acids targeting onco-fusion transcription factors in metastatic tumor animal models using targeted bioPROTAC degradation or genomic editing strategies. Successful efforts should demonstrate effective delivery and expression in-vivo to tumor cells, and downregulation of the target transcription factor protein while minimizing off-target effects and limiting sequestration of the nanoparticle by the liver, spleen, and lungs. • Research to exhaustively characterize the plasma-membrane protein expression (surfaceome) of an ultra-rare cancer and the presumed healthy tissue of origin, as well as the resident-tissue stem cells, by single-cell transcriptomics and proteomics. These studies, and available correlative database analyses, should be designed to identify possible combinatorial signatures of plasma membrane proteins unique to the ultra-rare tumor. Tumors of interest include Sclerosing epithelioid fibrosarcoma and atypical teratoid rhabdoid tumors (ATRT).
Other open grants from the Department of Health and Human Services
| Opportunity | Status | Closes | Award ceiling | Total funding | Record |
|---|---|---|---|---|---|
| Long-term health outcomes of people living with spina bifida CDC-RFA-DD-26-0222 | Open | Oct 26 | $300,000 | $3,000,000 | grants.gov |
| GREGoRi Data Coordination and Outreach Center (U01, Clinical Trials Not Allowed) RFA-HG-27-011 | Open | Oct 30 | $1,250,000 | $2,000,000 | grants.gov |
| GREGoRi Innovation Projects (U01 Clinical Trial Optional) RFA-HG-27-013 | Open | Oct 30 | $500,000 | $7,500,000 | grants.gov |
| GREGoRi Technology Integration Center (U01, Clinical Trials Optional) RFA-HG-27-012 | Open | Oct 30 | $2,250,000 | $3,000,000 | grants.gov |
| HEAL Initiative: Whole Joint Health Program (R61/R33 Clinical Trial Required) PAR-27-045 | Open | Oct 30 | grants.gov | ||
| Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR-24-280 | Open | Nov 2 | grants.gov |
All grants open to County governments · All grants open to Independent school districts · All grants open to City or township governments
Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.