Cambridge, Massachusetts-based Zag Bio said it has advanced its lead program, ZAG-101, into clinical development for type 1 diabetes (T1D), and that the first-in-human Phase Ib/IIa LANTERN trial will initially enroll adults with Stage 3 T1D.
ZAG-101 is a bifunctional antibody designed to deliver pancreatic beta-cell antigens to antigen-presenting cells in the thymus, with the aim of re-establishing central immune tolerance. Zag Bio said that advances in insulin delivery and glucose monitoring have improved type 1 diabetes (T1D) management but do not address the underlying autoimmune process responsible for progressive beta-cell destruction.
LANTERN will evaluate single and multiple ascending doses administered intravenously and subcutaneously, assessing safety, tolerability, pharmacokinetics and pharmacodynamics. C-peptide measurements will assess preservation of endogenous insulin production, while immune assays will evaluate regulatory and effector T-cell responses as pharmacodynamic markers. The trial will initially enroll patients in Australia and Europe.
The disease-modifying T1D landscape includes both beta-cell preservation and replacement approaches. Sanofi’s teplizumab, an anti-CD3 antibody, was first approved in 2022 to delay progression from Stage 2 to Stage 3 T1D and in June 2026 gained accelerated approval to delay loss of endogenous insulin production in recently diagnosed patients aged 8 to 17. Vertex Pharmaceuticals is advancing zimislecel, an allogeneic stem-cell-derived islet-cell therapy, through a Phase I/II/III program in patients with impaired hypoglycemia awareness.