Grants / Department of Health and Human Services / Food and Drug Administration

Novel approaches to support therapeutic development in ultra-rare cancers

Forecast Forecast, no dates yet Opportunity FOR-FD-26-004

• Award ceilingnot stated
• Award floornot stated
• Expected awards2
• Total fundingnot stated
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity is open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities/Indian housing authorities
• Native American tribal organizations (other than Federally recognized tribal 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
• Private institutions of higher education
• For profit organizations other than small businesses
• Small businesses

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

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.

Category: Agriculture, Consumer Protection, Food and Nutrition.

How to apply

1. Read the full notice and attachments on Grants.gov. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Patrick Johnson, Grants Management Specialist, patrick.johnson@fda.hhs.gov, 301-796-0154.

Open the official notice