Neoantigen-Based Therapeutic Targeting of Head and Neck Cancers (R01) | RFA DE 18 004

Frequently Asked Questions (FAQs)

What is the name and identifier of this funding opportunity?

The opportunity is titled "Neoantigen-Based Therapeutic Targeting of Head and Neck Cancers (R01)" and is identified as RFA-DE-18-004.

Which agency is offering this grant?

This is a National Institutes of Health (NIH) discretionary research grant opportunity.

What grant mechanism does this opportunity use?

The funding opportunity uses the NIH R01 research project grant mechanism.

What is the main scientific purpose of this FOA?

The core goal is to advance basic and preclinical research that identifies tumor-specific neoantigens in human head and neck cancers (HNC) and evaluates whether those neoantigens can serve as practical therapeutic targets capable of triggering strong anti-tumor immune responses in relevant patient populations.

What types of cancers are included under "head and neck cancers" for this FOA?

The FOA focuses on head and neck cancers and specifically includes salivary gland cancers, indicating the program is not limited only to the most common head and neck tumor sites.

What are neoantigens in the context of this opportunity?

Neoantigens are novel peptide sequences that can arise from tumor mutations and are not present in normal tissues. Because they are tumor-specific, they are considered attractive targets for precision immunotherapy approaches.

Why does this FOA emphasize neoantigens rather than broadly acting immune approaches?

The FOA aims to move beyond broadly acting immune strategies by focusing on tumor-specific targets. Neoantigen targeting is intended to direct immune responses toward malignant cells while minimizing damage to healthy tissue.

What are the two main expected project components under this FOA?

Projects are expected to: (1) identify and validate HNC-specific neoantigens in human disease; and (2) test the usefulness of those neoantigens as immune targets in basic or preclinical settings.

What kinds of research activities are implied as being responsive to this FOA?

Responsive work can include discovering candidate neoantigens from patient tumor material, confirming that candidate neoantigens are processed and presented to the immune system, and assessing whether immune cells can recognize them and mount tumor-killing responses.

Does this FOA require clinical trials?

The description emphasizes basic and preclinical testing and notes that the announcement is intended to generate evidence strong enough to justify later-stage translational development, even if this FOA itself is not a clinical trial mechanism.

What is the intended outcome or deliverable from funded projects?

The FOA is intended to produce prioritized and validated neoantigen candidates (not just lists of mutations), along with evidence supporting their relevance to HNC patients and their potential to be developed into next-generation immunotherapies.

What types of immunotherapy strategies are mentioned or implied?

The FOA references precision immunotherapy approaches including vaccine strategies and T-cell based strategies designed to direct the immune system toward malignant cells using tumor-specific neoantigens.

What is the funding activity category and CFDA number listed?

The funding activity category is Health, and the CFDA number provided is 93.121.

What is the award ceiling for this opportunity?

The posted award ceiling is $350,000, which indicates the approximate maximum amount expected per award under the announcement.

How many awards will NIH make under this FOA?

The number of expected awards is not specified in the provided information, which typically suggests flexibility based on application quality and available funds.

Is this an always-open NIH opportunity?

No. The provided dates indicate it is a time-limited solicitation rather than an always-open program announcement.

What are the key dates mentioned for this FOA?

The FOA creation date is February 27, 2017, and the original closing date listed is June 19, 2017.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. domestic organizations and certain non-U.S. entities (foreign organizations).

Which U.S. government entities are eligible applicants?

Eligible government applicants include state, county, city/township, and special district governments.

Are tribal governments and tribal organizations eligible?

Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments. The FOA also highlights Indian/Native American tribal governments other than federally recognized.

Are higher education institutions eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are minority-serving institutions specifically encouraged or listed as eligible?

Yes. The FOA explicitly highlights Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and other categories NIH sometimes calls out to encourage broad participation.

Can nonprofits apply?

Yes. Eligible applicants include nonprofits with and without 501(c)(3) status (with the noted classification caveat that they are not institutions of higher education in that classification, as described in the provided eligibility language).

Can for-profit organizations apply?

Yes. Eligible applicants include for-profit organizations other than small businesses, and small businesses are also eligible.

Are independent school districts eligible?

Yes. Independent school districts are listed among eligible applicants.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are included as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly highlights faith-based or community-based organizations among the additional eligible applicant categories.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are listed among the highlighted eligible applicant categories.

Are non-U.S. (foreign) organizations eligible?

Yes. The FOA indicates that non-domestic (non-U.S.) entities (foreign organizations) are eligible.

Are federal agencies eligible applicants?

Yes. Eligible federal agencies are included among the highlighted applicant categories.

What kind of research team is this FOA aimed at?

It is aimed at teams that can connect tumor genomics and immunology to identify credible neoantigen targets for head and neck malignancies and demonstrate, in rigorous laboratory and preclinical models, that those targets can generate meaningful immune responses against cancer.

What distinguishes a strong application under this FOA based on the description provided?

Based on the provided description, the FOA emphasizes more than mutation discovery. It points toward applications that prioritize and validate neoantigens in human HNC and provide evidence (in basic and preclinical work) that these neoantigens are processed/presented and can be recognized by immune cells to drive anti-tumor responses.

Does this FOA limit the work to a single head and neck tumor site?

No. The FOA includes head and neck cancers broadly and explicitly includes salivary gland cancers, signaling the scope is not restricted to only the most common head and neck tumor sites.