Monoclonal antibody therapy for hepatitis D virus-driven sjogren's disease
A novel therapeutic approach using monoclonal antibodies to clear Hepatitis D Virus (HDV) reservoirs in Sjogren's Disease patients. By bypassing immune tolerance mechanisms, this mAb-based therapy targets HDV in salivary gland tissue to potentially cure HDV-associated autoimmunity, addressing an unmet need where vaccination is ineffective.
Overview
This research proposes a monoclonal antibody (mAb) therapeutic approach to treat Sjogren's Disease (SjD) driven by Hepatitis D Virus (HDV). The investigator has discovered that HDV plays a pivotal role in triggering the SjD phenotype, with HDV detected in salivary gland tissue of affected patients. Notably, these patients (and murine models) fail to develop anti-HDV antibodies, indicating immune tolerance to the pathogen. Because vaccination cannot reliably overcome this tolerance, monoclonal antibodies represent the only viable therapeutic strategy to clear HDV from tissue reservoirs and potentially cure this autoimmune condition.
Technical specifications
- Targeted pathogen clearance: Monoclonal antibodies designed against HDV to bypass natural tolerance mechanisms and enable controlled clearance of viral reservoirs in salivary gland tissue
- Validated murine model: Established HDV murine model with demonstrated SjD phenotype development, including measurable saliva flow reduction, autoantibody profiles, and focal salivary gland inflammation
- Multiple fixed dose approach: Treatment protocols designed to evaluate efficacy across repeated dosing regimens
- Comprehensive phenotype assessment: Validation includes evaluation of saliva flow, autoantibody profiles, and focal inflammation under positive and negative anti-HDV mAb treatment conditions
- Off-target evaluation: Assessment of potential off-target effects of mAb treatment to ensure safety profile
Technology readiness level
This research is at an early-to-mid preclinical stage. The HDV murine model has been established and characterized, demonstrating the SjD phenotype development. The next phase involves evaluating mAb treatment capacity to correct the SjD phenotype using a multiple fixed dose approach. Anticipated outcomes include alleviation of the SjD phenotype, validation of repeated treatment protocols, and assessment of off-target effects. The work is supported by the University of Utah's research infrastructure and technology commercialization capabilities, with potential for translation toward clinical development.
About University of Utah
The University of Utah is a comprehensive public research university in Salt Lake City, paired with the resources of a major academic medical center. Industry partners engage through an on-campus research and technology park that co-locates companies with faculty labs and shared core facilities. Clinical integration supports large-scale trials and translation, while proximity to Silicon Slopes expands access to regional innovation partners. Research is supported by competitive federal funding from NIH and NSF, with additional awards from DOE and the Department of Defense. A dedicated technology commercialization office manages IP, licensing, startup formation, and corporate engagement, with incubator space in the research park.
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