# Novel approaches to support therapeutic development in ultra-rare cancers

Source: https://welltoldgrants.com/grants/for-fd-26-004-novel-approaches-to-support-therapeutic-development-in-ultra/  
Official notice: https://www.grants.gov/search-results-detail/360223

> Food and Drug Administration plans to offer grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expects to make about 2 awards. It is a forecast, and no dates have been set yet.

| Field | Value |
|---|---|
| Opportunity number | FOR-FD-26-004 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | not set |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | 2 |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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

## 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.

## Questions people ask

### Who can apply for Novel approaches to support therapeutic development in ultra-rare cancers?

Food and Drug Administration accepts applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

### What is the deadline for Novel approaches to support therapeutic development in ultra-rare cancers?

Forecast, no dates yet. Confirm the date and time in the official notice on Grants.gov.