LANTERN Phase 1b/2a trial will evaluate Zag Bio’s lead program in people with Type 1 diabetes

Study will assess safety and pharmacology, with C-peptide measured for early signs of efficacy

Zag Bio™, Inc., a biotechnology company working to set a new standard for treating autoimmune disease, today announced it has advanced its lead program for Type 1 diabetes (T1D), ZAG-101, into clinical development. The company’s first-in-human Phase 1b/2a clinical trial (LANTERN) will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZAG-101 and explore its potential to preserve insulin-producing beta-cell function.

“Advancing ZAG-101 into the clinic marks Zag’s transition to a clinical stage company,” said Jason Cole, Chief Executive Officer of Zag Bio. “We are beginning in Type 1 diabetes, where there remains a significant unmet need for safe, durable therapies that can address the underlying autoimmune process and help patients maintain natural insulin production. The LANTERN study is an important first step toward translating the biology behind our thymic-targeted antibody technology, which aims to harness the body’s natural mechanisms for establishing immune tolerance.”

ZAG-101 in Type 1 Diabetes

T1D is a chronic autoimmune disease in which the immune system attacks and destroys insulin-producing beta cells in the pancreas. While advances in insulin delivery and glucose monitoring have improved disease management, they do not address the underlying autoimmune process responsible for progressive beta-cell destruction and insulin dependence.

ZAG-101 is a bifunctional antibody designed to deliver an insulin-derived antigen directly to antigen-presenting cells in the thymus. By harnessing the natural role of the thymus in establishing central immune tolerance, ZAG-101 is designed to generate long-lived antigen-specific, thymus-derived regulatory T cells (Tregs) in vivo, while reducing autoreactive conventional T cells. These Tregs then migrate to the pancreas, where they are designed to suppress the autoimmune response and protect remaining beta cells.

In preclinical studies, ZAG-101 has demonstrated the ability to generate antigen-specific Tregs and increase the ratio of regulatory to conventional T cells in the thymus. In disease-relevant models, the approach has demonstrated disease efficacy and tissue-specific bystander immune suppression, an important immunomodulatory feature of thymic Tregs.

“People living with Type 1 diabetes face the daily burden of managing a lifelong disease, and there remains a significant need for therapies that address the underlying autoimmunity,” said Jan Hillson, M.D., Chief Medical Officer of Zag Bio. “With LANTERN, we’re taking an important first step in evaluating ZAG-101 in people with T1D. What we learn will guide the continued development of ZAG-101 and our longer-term goal of reaching people earlier in the course of disease, when there may be greater opportunity to preserve beta-cell function.”

LANTERN Phase 1b/2a Trial Design

The first-in-human Phase 1b/2a clinical trial will initially enroll adults with Stage 3 T1D and evaluate single and multiple ascending doses of ZAG-101. Both intravenous and subcutaneous administration are planned to inform potential future dosing regimens.

The study will assess safety, tolerability and pharmacology, together with metabolic and mechanistic endpoints intended to provide early evidence of biological activity. These include C-peptide, a measure of endogenous insulin production and beta-cell function, as well as immune assays designed to evaluate regulatory and effector T-cell responses.

Following initial evaluation in adults, Zag Bio plans to expand clinical development to adolescents with Stage 3 T1D and, ultimately, to earlier stages of disease where preservation of beta-cell function could potentially have greater impact.

The clinical program will initially enroll patients in Australia and Europe.

About Zag Bio

Zag Bio™ is a clinical-stage biotechnology company pioneering thymus-targeted medicines designed to restore immune tolerance and set a new standard for the treatment of autoimmune diseases. Zag Bio designs bifunctional antibodies that deliver self-antigens to antigen-presenting cells in the thymus, harnessing the body’s natural process to generate antigen and tissue specific regulatory T-cells (Tregs) that can address autoimmune disease. The company’s lead program, ZAG-101, is in clinical development for Type 1 diabetes, with additional programs being advanced for other autoimmune diseases. Located in Cambridge, Massachusetts, Zag Bio brings together experienced leaders in thymus biology, autoimmune disease and innovative drug development.

For more information, visit Zag Bio’s website and follow the company on LinkedIn.

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