RFA-FD-26-004: FDA Office of Women's Health Research

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gov Maintenance Calendar # View Grant Opportunity Forecast View similar opportunities Novel approaches to support therapeutic development in ultra-rare cancers Department of Health and Human Services Food and Drug Administration Note: This is a Forecasted Opportunity.

Document Type:Grants Notice Opportunity Number:FOR-FD-26-004 Opportunity Title:Novel approaches to support therapeutic development in ultra-rare cancers Opportunity Category:Discretionary Opportunity Category Explanation: Funding Instrument Type:Cooperative Agreement Category of Funding Activity:Agriculture Expected Number of Awards:2 Assistance Listings:93.

103 -- Food and Drug Administration Research Cost Sharing or Matching Requirement:No Forecasted Date:Aug 04, 2025 Last Updated Date:Jan 08, 2026 Estimated Application Due Date: Estimated Project Start Date: Estimated Total Program Funding: Eligible Applicants:Native American tribal governments (Federally recognized) City or township governments 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 For profit organizations other than small businesses Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education Additional Information on Eligibility: ## Additional Information Agency Name:Food and Drug Administration Description: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). Link to Additional Information:[](https://www. grants.

gov/search-results-detail/360223) Grantor Contact Information:Patrick Johnson Grants Management Specialist ## Similar Opportunities (identified by AI) #### Health & Human Services * Frequently Asked Questions ## Your session will expire in 3 minutes. To continue working, click on the "OK" button below. This is being done to protect your privacy.

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