Drug intelligence / Profile preview

ABBV-368 + tilsotolimod + nab-paclitaxel + budigalimab

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, Small Molecules
Administration
Intravenous, Intratumoral, Intravenous (other Agents)
01

Overview

This is an investigational combination drug regimen composed of four agents: - **ABBV-368**: a human monoclonal antibody targeting OX40 (TNFRSF4), a co-stimulatory immune checkpoint receptor expressed on T cells, developed to enhance antitumor immune responses. - **Tilsotolimod (IMO-2125)**: a synthetic oligonucleotide agonist of toll-like receptor 9 (TLR9), designed to stimulate innate immune activation and antigen presentation within the tumor microenvironment. - **Nab-paclitaxel**: a nanoparticle albumin-bound formulation of paclitaxel, an established antineoplastic chemotherapy drug that stabilizes microtubules, preventing cell division and inducing apoptosis in cancer cells. - **Budigalimab (ABBV-181)**: a programmed cell death protein 1 (PD-1) inhibitor, functioning as an immune checkpoint inhibitor to block negative regulation of T cells and bolster antitumor immunity. The combination is being evaluated in early-phase clinical studies (phase 1) for advanced or metastatic solid tumors, notably triple negative breast cancer and head and neck squamous cell carcinoma, with the aim of synergistically activating both innate and adaptive arms of the immune system while directly targeting tumor proliferation pathways[1][3].

Other names
ABBV-368 + tilsotolimod + nab-paclitaxel + budigalimab
02

Targets

CD28 (Cluster of Differentiation 28)PDCD1 (Programmed cell death protein 1 receptor)TLR9 (Toll-like receptor 9)TUBB (Tubulin (alpha and beta subunits))

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