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Glycosaminoglycans to Treat and Prevent Radiation-Induced Oral Mucositis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1DE024024-04
Agency Tracking Number: SB1DE024024
Amount: $2,826,053.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PAR20-129
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-20
Award End Date (Contract End Date): 2024-02-29
Small Business Information
Salt Lake City, UT 84108-1228
United States
DUNS: 827444345
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (801) 649-3999
Business Contact
Phone: (801) 649-3999
Research Institution

Project Summary/Abstract
Oral mucositis is a devastatingly painful inflammatory disease that frequently develops during cancer therapy
and affects half a million Americans. The accompanying pain is so severe that patients often require narcotic
pain medicines. The clinical manifestations are ulcers in the mouth and gastrointestinal tract, which are
exacerbated by opportunistic infections. Many patients also suffer from dry mouth causing difficulty in
swallowing because of the decreased salivary gland function. As a result, these patients often need feeding
tubes which interrupts their cancer treatment. The financial burden to the patient is staggeringly high, costing
an additional $17,000 to $40,000 for each patient. Preventing oral mucositis will greatly enhance the cancer
therapy as well as the wellness of the patients. GlycoMira's lead candidate, GM-1111, is a new class of anti-
inflammatory drugs that modulate an overactive innate immune system when administered via once daily
subcutaneous injection. The SBIR Phase I and II study results demonstrate its powerful efficacy in reducing the
severity and the occurrence of the disease in radiation-induced oral mucositis models: GM-1111 reduced
tissue ulceration and inflammation in the tongue. Histologically, oral tissues from the GM-1111 treated group
showed markedly reduced damages in the epithelium with mild infiltration of leukocytes, thicker mucosal layers
and prevention of mucous glandular alterations compared to the tissues from vehicle treated controls.
Biochemical and gene expression analyses of the diseased tissues revealed increased expression of Toll-like
receptors, NLRP3 inflammasome as well as their downstream pro-inflammatory cytokines all of which were
reduced with GM-1111 treatment. Overall, the data suggest that GM-1111 has substantial potential to reduce
oral mucositis in humans. GlycoMira also manufactured cGMP compliant GM-1111 and generated its
manufacturing specifications. To further develop a commercially viable therapeutic for oral mucositis, we
propose studies that will be used for the Investigative New Drug (IND) application to the FDA for clinical trials.
The objectives are to (1) delineate the safety profiles of GM-1111 in nonclinical studies and (2) manufacture
clinical trial ready sterile drug product (aseptic fill/finish and labeling/packaging) and test its stability. The
results of the proposed research will lead the drug development to the clinical stage through IND application
and propel the commercialization of the drug to the patients suffering from this devastating disease.

* Information listed above is at the time of submission. *

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