Drug intelligence / Profile preview

TUB-040

Development stage
Phase 2
Lead developer
Gilead Sciences
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

TUB-040 is a next-generation antibody-drug conjugate (ADC) developed by Tubulis for the treatment of platinum-resistant high-grade ovarian cancer and relapsed/refractory non-small cell lung cancer (NSCLC). It consists of a humanized IgG1 monoclonal antibody targeting NaPi2b, an antigen highly overexpressed in ovarian and lung adenocarcinoma, linked to the topoisomerase I inhibitor exatecan via a cleavable linker using Tubulis’ proprietary P5 conjugation technology. This design enables highly stable, specific tumor targeting with minimal off-target toxicity and durable antitumor responses. TUB-040 has demonstrated superior efficacy in preclinical models compared to other ADCs and is currently being evaluated in phase 1/2a clinical trials. The drug received FDA Fast Track designation for platinum-resistant ovarian cancer.

Other names
anti-napi2b/exatecan antibody-drug conjugate tub-040
02

Targets

TOP1 (DNA Topoisomerase I)SLC34A2 (Sodium-dependent phosphate transporter type IIb)

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