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Preclinical assessment of a novel compound for treating radiation-induced oral mucositis

Award Number: R44DE031464
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Preclinical assessment of a novel compound for treating radiation-induced oral mucositis - Oral mucositis (OM) is a debilitating side effect of chemo- and radiotherapy, characterized by inflammation and ulceration of the oral mucosa. Despite the significant unmet medical need, there are no FDA-approved therapies for OM in solid-tumor indications. Limited publicly accessible market research data is available, making it challenging to clearly define the commercial opportunity for novel OM therapeutics. In a recent TABA Needs Assessment report from RTI International and through SEED Entrepreneur-in-Residence consultation, a recommendation was made to pursue a TABA supplement to support a targeted market-opportunity assessment for the small-molecule OM therapeutic candidate. This supplement will fund consulting services to conduct market research. The selected vendor has extensive experience conducting commercial assessments in the oral and gastrointestinal mucositis markets. Their work will include detailed primary market research through double-blind interviews with key opinion leaders specializing in OM management and head and neck cancer treatment, complemented by secondary market analysis. Expected deliverables include epidemiological insights, competitive intelligence, refined target product profiles, pricing benchmarks, and clinical development pathway considerations. The insights generated will directly inform the commercialization plan and address critical gaps identified in the recent TABA Needs Assessment.


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: 2025 ( Subtotal = $888,843 )
2025	2025	SINOPIA BIOSCIENCES INC	3210 MERRYFIELD ROW	SAN DIEGO	CA	92121	SAN DIEGO	USA	Oral Diseases and Disorders Research	001	3	8/15/2025	SUPPLEMENT FOR EXPANSION	$39,650
2025	2025	SINOPIA BIOSCIENCES INC	3210 MERRYFIELD ROW	SAN DIEGO	CA	92121	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	3	8/4/2025	NON-COMPETING CONTINUATION	$849,193
														Subtotal = $888,843

Issue Date FY: 2024 ( Subtotal = $1,493,635 )
2024	2024	SINOPIA BIOSCIENCES INC	3210 MERRYFIELD ROW	SAN DIEGO	CA	92121	SAN DIEGO	USA	Oral Diseases and Disorders Research	001	2	9/25/2024	COMPETING CONTINUATION	$174,104
2024	2024	SINOPIA BIOSCIENCES INC	3210 MERRYFIELD ROW	SAN DIEGO	CA	92121	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	2	9/4/2024	COMPETING CONTINUATION	$1,319,531
														Subtotal = $1,493,635

Grand Total All Awards = $2,382,478

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Preclinical assessment of a novel compound for treating radiation-induced oral mucositis

Award Number: R44DE031464

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/05/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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