2026 is off to a strong start. We are pleased to share that our portfolio company GenEditBio has achieved a significant regulatory milestone: its lead clinical asset, GEB-101, has received FDA clearance of its IND application, enabling the initiation of the Phase 1/2 CLARITY trial.

GEB-101 is a first-in-class investigational genome-editing therapy for TGFBI corneal dystrophy, delivered as a ribonucleoprotein via GenEditBio’s proprietary protein delivery vehicle (PDV) technology. This FDA clearance validates the robustness of the company’s preclinical safety and efficacy data and represents an important step toward bringing transformative genome-editing therapies to patients worldwide.

The Phase 1/2 CLARITY trial will evaluate the safety, tolerability, and preliminary efficacy of GEB-101. Patient enrollment is expected to begin in Q2 2026, following site activation in the United States.

This milestone reflects the dedication and execution of the GenEditBio team in advancing preclinical innovation into the clinical stage with rigor, professionalism, and speed.

GenEditBio remains committed to developing fundamentally safe, effective, and accessible in vivo genome-editing therapies for genetic diseases with significant unmet medical needs.