Comprehensive Report on INM004: An Investigational Anti-Shiga Toxin Therapy for Hemolytic Uremic Syndrome

1. Executive Summary

INM004 (DrugBank ID: DB17791) is an investigational biotherapeutic agent developed by the Argentinian company Inmunova S.A..[1] It consists of polyclonal F(ab')2​ antibody fragments derived from equine immunoglobulins.[1] The therapy is designed to neutralize Shiga toxins (Stx1 and Stx2), the primary causative agents of Shiga toxin-producing Escherichia coli (STEC)-associated Hemolytic Uremic Syndrome (STEC-HUS).[5] By targeting the B subunits of these toxins, INM004 aims to prevent their binding to host cell receptors, thereby blocking toxin internalization and subsequent cellular damage, particularly in the kidneys.[6] STEC-HUS represents a significant unmet medical need, especially in pediatric populations where it is a leading cause of acute kidney injury.[5] Currently, treatment relies on supportive care, with no approved therapies specifically targeting the Shiga toxin.[2]