AVT-80: An Investigational Biosimilar to Vedolizumab for Inflammatory Bowel Disease

I. Executive Summary

AVT-80 is an investigational monoclonal antibody currently under development by Alvotech Swiss AG.[1] It is engineered as a biosimilar to the approved biologic drug vedolizumab, which is marketed under the brand name Entyvio®. The development program for AVT-80 is strategically positioned within the growing landscape of biosimilar therapies, aiming to offer a comparable alternative for the treatment of inflammatory bowel diseases (IBD).

Currently, AVT-80 is advancing through Phase I clinical development.[3] The cornerstone of this phase is a clinical trial (NCT06732804) meticulously designed to establish pharmacokinetic (PK) similarity, as well as comparable safety and immunogenicity, between AVT-80 and its reference product, vedolizumab. This initial human study is being conducted in healthy volunteers.

The mechanism of action of AVT-80 is expected to mirror that of vedolizumab. This involves the specific targeting of the α4β7 integrin, a protein predominantly found on the surface of gut-homing T helper lymphocytes.[5] By binding to α4β7 integrin, AVT-80 is anticipated to inhibit its interaction with Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on endothelial cells within the gastrointestinal tract. This blockade is designed to prevent the migration of pathogenic lymphocytes into the gut tissue, thereby exerting a gut-selective anti-inflammatory effect.[7]