Budigalimab (ABBV-181): A Comprehensive Clinical, Pharmacological, and Strategic Analysis

Executive Summary

Budigalimab (ABBV-181) is an investigational, humanized immunoglobulin G1 (IgG1) monoclonal antibody developed by AbbVie, targeting the programmed cell death 1 (PD-1) receptor. As an immune checkpoint inhibitor, its fundamental mechanism of action aligns with a well-established and transformative class of oncology therapeutics. It functions by blocking the interaction between PD-1 on T-cells and its ligands, primarily PD-L1, thereby preventing tumor-induced immune suppression and reactivating a cytotoxic T-cell response against malignant cells. A distinguishing feature of Budigalimab's molecular architecture is its IgG1 backbone, which has been specifically engineered with point mutations (L234A, L235A) in the Fc region to abrogate effector functions, such as antibody-dependent cell-mediated cytotoxicity. This design choice suggests a strategic focus on creating a highly specific and immunologically inert checkpoint blockade agent, optimized for safety and predictability in combination regimens.