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Validating immune and epigenetic biomarkers of immunotherapy response in head and neck squamous cell carcinoma

Award Number: U01DE036036
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Validating immune and epigenetic biomarkers of immunotherapy response in head and neck squamous cell carcinoma - ABSTRACT Recent advances in immunologic approaches to curative treatment have changed the landscape of cancer research and patient management, including for head and neck squamous cell carcinoma (HNSCC). Still, the development of validated biomarkers of immunotherapy response has not kept pace, and immunotherapy response rates for HNSCC are low (15-20%). PD-L1 checkpoint activity and tumor mutational burden (TMB) are only modestly associated with anti-tumor activity and remain inadequate for predicting treatment response. As clinical research advances, first line neoadjuvant immunotherapy for HNSCC will become the new standard of care and dramatically expand the scope of HNSCC patients who receive checkpoint immunotherapy, enhancing the already urgent need for validated companion tests that discern treatment response. In a prospective, multisite study, we identified immune profiling biomarkers that, in conjunction with TMB, can stratify patients into responders and non-responders. To maximize patient benefit, there is a need to validate our novel biomarkers. Consistent with our approach of interrogating peripheral blood at the time of initiation of immunotherapy, exciting new data demonstrate that routinely collected blood lab tests associate with pan-cancer immunotherapy efficacy, although this is poorly studied in HNSCC. We propose to expand our prospective observational cohort of HNSCC patients receiving checkpoint immunotherapy at Dana Farber Cancer Institute and Dartmouth Cancer Center to include patients from Rhode Island Hospital and MD Anderson Cancer Center. We will validate immune biomarkers of immunotherapy treatment response in HNSCC using standard-of-care complete blood count differential (CBC diff), serum cytokine profiling, and our DNA methylation-based immune profiling methods called for more detailed immune profiling. We hypothesize that by combining clinical covariates with extracellular and cellular immune profile data will significantly improve biomarker performance for immunotherapy response assessment beyond each of these elements alone. In addition, our approach will inform precision oncology approaches for HNSCC. Validated models of immunotherapy treatment response will foster wider adoption of prognostic modeling in HNSCC patients and increase the successful management of HNSCC.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $790,963 )
2026	2026	TRUSTEES OF DARTMOUTH COLLEGE	7 LEBANON ST	HANOVER	NH	03755	GRAFTON	USA	Oral Diseases and Disorders Research	000	1	7/17/2026	NEW	$790,963
														Subtotal = $790,963

Grand Total All Awards = $790,963

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Validating immune and epigenetic biomarkers of immunotherapy response in head and neck squamous cell carcinoma

Award Number: U01DE036036

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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