Opportunity Information: Apply for RFA CA 27 005
The Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required) funding opportunity (RFA-CA-27-005) is a National Cancer Institute (NCI), NIH initiative designed to speed up the development of better treatments for adult glioblastoma (GBM), one of the most aggressive brain cancers. The core aim is to move promising therapies from late-stage preclinical development into first-in-human testing, with a strong emphasis on therapies that can cross the blood-brain barrier (BBB), a major hurdle that limits many drugs from reaching tumor tissue in the brain. The program is built around the idea that if a therapy shows encouraging signals in early clinical work under this award, it should be positioned to transition smoothly into later-stage testing through established NCI clinical trial mechanisms, rather than stalling in the typical gap between discovery and larger trials.
This NOFO uses a cooperative agreement mechanism (U19), meaning the work is expected to be highly collaborative and coordinated, with substantial scientific and programmatic involvement from NCI compared with a standard research grant. NCI intends to establish a network of tightly integrated, cross-cutting teams, each capable of driving one or more therapeutic candidates along a continuous pipeline: late preclinical studies, IND-enabling work and regulatory preparation, and then early clinical evaluation in humans (generally Phase 0 and/or Phase 1-type studies). In practical terms, the network structure is meant to ensure teams have, or can assemble, the full set of capabilities needed for translational drug development in GBM, including the scientific, operational, and regulatory expertise to actually open and execute early-stage clinical trials.
Therapeutic candidates supported under this program can fall into two broad categories. First, they may be truly novel agents developed specifically with GBM biology and BBB penetration in mind. Second, they may be existing drugs or combinations that are already approved for other diseases but are being repurposed for GBM, as long as the application provides appropriate and convincing preclinical evidence supporting their potential benefit in GBM and their ability to reach relevant targets in the brain. This flexibility is important because repurposing can sometimes reduce development time and risk, but the NOFO still expects rigorous rationale and translational evidence rather than speculative use of existing drugs.
A key point of the opportunity is its deliberate scope: it targets the stretch of the GBM drug-development pathway that often lacks consistent support, sitting between academic or early discovery work and the larger NCI trial infrastructure. By funding activities from late preclinical through early clinical stages, the GTN is intended to de-risk and mature candidates to the point where they are ready for more definitive, later-phase evaluation. The explicit requirement that clinical trials be conducted as part of the award underscores that the program is not just about generating preclinical data, but about producing actionable clinical translation in adults with GBM.
Eligibility is broad across U.S.-based organizations, spanning public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including those other than small businesses), small businesses, and various government entities (state, county, city/township, special district), as well as certain tribal governments and tribal organizations, and public housing/Indian housing authorities. However, the NOFO is clear in restricting non-U.S. participation on the applicant side: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. In other words, the funded work and formal project components must remain within allowable U.S. organizational boundaries under NIH rules.
From the provided opportunity details, the agency anticipates making about four awards, with an award ceiling listed as $700,000. The opportunity is categorized as discretionary funding and sits within the NIH health activity area, with CFDA numbers 93.394 and 93.395. The original application closing date is listed as 2026-10-01, and the opportunity record creation date is 2026-08-31. Overall, the GTN U19 is best understood as a focused, network-based translational program meant to generate clinically testable, BBB-penetrant GBM therapies and to push them into early human trials in a coordinated way that sets up successful candidates for rapid progression into later-stage NCI-supported clinical testing.Apply for RFA CA 27 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394, 93.395.
- This funding opportunity was created on 2026-08-31.
- Applicants must submit their applications by 2026-10-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $700,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: 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, Others.
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Frequently Asked Questions (FAQs) - Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required) (RFA-CA-27-005)
What is the Glioblastoma Therapeutics Network (GTN) funding opportunity?
The Glioblastoma Therapeutics Network (GTN) (U19 Clinical Trial Required) opportunity (RFA-CA-27-005) is a National Cancer Institute (NCI), NIH initiative focused on accelerating the development of improved treatments for adult glioblastoma (GBM). It is designed to move promising therapeutic candidates from late-stage preclinical development into first-in-human testing.
What disease area does this program focus on?
This program focuses on adult glioblastoma (GBM), described in the opportunity as one of the most aggressive brain cancers.
What is the main goal of the GTN program?
The core aim is to speed translation of promising therapies into early clinical testing in humans. The program specifically targets the stage between late preclinical development and early human trials, with the intent to position candidates to transition into later-stage testing through established NCI clinical trial mechanisms if early signals are encouraging.
Is blood-brain barrier (BBB) penetration important for this NOFO?
Yes. A strong emphasis is placed on therapies that can cross the blood-brain barrier (BBB), which is described as a major hurdle that prevents many drugs from reaching tumor tissue in the brain.
What funding mechanism is used for this opportunity?
This NOFO uses a cooperative agreement mechanism (U19). Under this mechanism, the work is expected to be highly collaborative and coordinated, and NCI will have substantial scientific and programmatic involvement compared with a standard research grant.
What does it mean that this is a cooperative agreement (U19)?
Based on the opportunity description, a U19 cooperative agreement means NCI expects a coordinated, collaborative network, and NCI will be more actively involved in the scientific and programmatic aspects of the work than under a typical research grant.
What kind of program structure is NCI trying to build through GTN?
NCI intends to establish a network of tightly integrated, cross-cutting teams. Each team is expected to be capable of driving one or more therapeutic candidates along a continuous translational pipeline, rather than addressing only isolated pieces of development.
What activities along the development pipeline are supported?
The network is intended to support a continuous pipeline that includes late preclinical studies, IND-enabling work and regulatory preparation, and early clinical evaluation in humans (generally Phase 0 and/or Phase 1-type studies).
Are clinical trials required under this opportunity?
Yes. The opportunity is explicitly described as “Clinical Trial Required,” and it emphasizes that the program is not only about generating preclinical data but about producing actionable clinical translation in adults with GBM through early-stage clinical trials.
What phases of clinical trials are generally expected?
The opportunity describes early clinical evaluation in humans as generally Phase 0 and/or Phase 1-type studies.
What types of therapeutic candidates can be supported?
Therapeutic candidates can fall into two broad categories: (1) truly novel agents developed with GBM biology and BBB penetration in mind, and (2) existing drugs or combinations already approved for other diseases that are being repurposed for GBM, provided appropriate and convincing preclinical evidence is included.
Are repurposed drugs allowed, or only brand-new therapies?
Repurposed drugs and combinations are allowed if the application provides appropriate and convincing preclinical evidence supporting potential benefit in GBM and the ability to reach relevant targets in the brain. The opportunity frames this as flexibility, but not as an invitation for speculative use without rigorous rationale and translational evidence.
What is the program trying to prevent in the GBM therapy development process?
The opportunity highlights a common “gap” between discovery/early academic work and larger clinical trial infrastructure. GTN is deliberately scoped to fund the stretch from late preclinical through early clinical stages so candidates do not stall before they can enter later-stage NCI trial mechanisms.
What capabilities are teams expected to have or assemble?
Teams are expected to have, or be able to assemble, the capabilities needed for translational drug development in GBM. The description specifically references scientific, operational, and regulatory expertise needed to open and execute early-stage clinical trials.
Who is the sponsoring agency for this opportunity?
The opportunity is an initiative of the National Cancer Institute (NCI), within NIH.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations, including: public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (including those other than small businesses); small businesses; and government entities (state, county, city/township, special district). Certain tribal governments and tribal organizations are included, as well as public housing/Indian housing authorities.
Are non-U.S. (foreign) organizations eligible to apply?
No. The NOFO restricts non-U.S. participation on the applicant side: non-domestic (non-U.S.) entities are not eligible to apply.
Can a U.S. organization include a non-U.S. component in the project?
No. The opportunity states that non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. The funded work and formal project components must remain within allowable U.S. organizational boundaries under NIH rules.
How many awards does NCI expect to make?
Based on the provided opportunity details, the agency anticipates making about four awards.
What is the award ceiling listed for this opportunity?
The award ceiling listed in the provided details is $700,000.
What is the application due date?
The original application closing date is listed as 2026-10-01.
When was the opportunity record created?
The opportunity record creation date is listed as 2026-08-31.
How is this opportunity categorized in terms of funding type and activity area?
The opportunity is categorized as discretionary funding and is within the NIH health activity area.
What CFDA numbers are associated with this opportunity?
The CFDA numbers provided are 93.394 and 93.395.
What is the intended “hand-off” path for successful candidates after early clinical work?
The opportunity explains that if a therapy shows encouraging signals in early clinical work under this award, it should be positioned to transition smoothly into later-stage testing through established NCI clinical trial mechanisms.
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