HTIC, Inc. is a University of Virginia spin-off dedicated to translating cutting-edge immunology research into transformative therapies for acute and chronic inflammatory diseases. Our work centers on developing precision biologics that modulate dysregulated innate immune pathways, with a particular focus on NETosis-an inflammatory mechanism that contributes to organ injury in sepsis, ARDS, trauma, and autoimmune disorders.
Neutrophil extracellular traps (NETs) are web-like structures that help capture and eliminate pathogens. However, excessive NETosis can become harmful, driving conditions such as sepsis, viral infections, autoimmune diseases, impaired diabetic wound healing, and cancer progression. Elevated citrullinated histone H3 (CitH3) is a recognized biomarker of NET-driven pathology and is closely linked to immune dysfunction and tissue injury.
Our lead program targets this biology with hCitH3-mAb, a humanized monoclonal antibody designed to selectively bind and neutralize CitH3-an intensely pro-inflammatory and cytotoxic NET component that promotes endothelial barrier breakdown, microvascular leakage, thrombosis, cytokine amplification, and multi-organ dysfunction. By neutralizing CitH3, our approach interrupts the destructive feedback loop of NETosis while preserving essential innate immune function.
Across multiple preclinical models of sepsis, ALI/ARDS, autoimmune injury, and trauma, hCitH3-mAb has demonstrated consistent benefits, including reduced mortality, improved organ integrity, and preserved tissue function.
HTIC recently received IND clearance from the U.S. FDA, enabling the launch of the clinical development program for hCitH3-mAb.
- Phase 1 will be a Single Ascending Dose (SAD) study in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics (PK).
- Phase 2a will be a multi-center SAD trial in patients with mild-to-moderate sepsis-induced ARDS to assess preliminary efficacy, safety, tolerability, PK, and pharmacodynamics (PD).
HTIC gratefully acknowledges the partners and funding organizations that helped achieve this milestone. We continue to seek additional collaborators and investment to advance hCitH3-mAb through Phase II clinical trials and beyond.