Drug intelligence / Profile preview

ABBV-368 + tilsotolimod

Development stage
Phase 1
Lead developer
AbbVie
Modality
Small Interfering RNA (siRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, MicroRNA (miRNA) → Small RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Antisense Oligonucleotides (ASOs) → Long RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Antisense DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Intratumoral
01

Overview

ABBV-368 + tilsotolimod is an investigational combination therapy comprising **ABBV-368**, a fully human agonistic monoclonal antibody targeting OX40 (tumor necrosis factor receptor superfamily member 4, TNFRSF4), and **tilsotolimod** (IMO-2125), a synthetic Toll-like receptor 9 (TLR9) agonist oligodeoxynucleotide. ABBV-368 is designed to activate OX40 on T cells, thereby enhancing T-cell proliferation and survival, and potentially boosting adaptive anti-tumor immune responses. Tilsotolimod activates TLR9 in dendritic cells and other antigen-presenting cells, leading to type I interferon production, dendritic cell maturation, and increased antigen presentation. When used together, the combination is intended to enhance both innate and adaptive immune responses against tumors, particularly in solid malignancies such as advanced melanoma. Preclinical and early clinical data suggest this combination may reprogram the tumor microenvironment and promote durable anti-tumor activity.

Other names
ABBV-368 + IMO-2125
02

Targets

CD28 (Cluster of Differentiation 28)TLR9 (Toll-like receptor 9)

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