Drug intelligence / Profile preview

nav-001

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

Overview

NAV-001 is a next-generation antibody-drug conjugate (ADC) designed to target and kill tumor cells expressing mesothelin (MSLN). It consists of a humanized IgG1 antibody chemically linked to the cytotoxic payload PNU-159682, a potent topoisomerase II inhibitor. NAV-001 is engineered to be refractory to inhibition by MUC16/CA125, a humoral immuno-oncology factor that can reduce ADC efficacy by hindering internalization in other mesothelin-targeted ADCs. This design allows NAV-001 to maintain robust anti-tumor activity against both MUC16/CA125-expressing and non-expressing tumor cells. Preclinical studies have demonstrated its efficacy in inducing tumor regression across various patient-derived xenograft models, including advanced lung adenocarcinoma, colonic cancer, and triple negative breast cancer. The drug is being developed as a monotherapy for mesothelin-positive cancers[1][3][5][6].

Other names
NAV-001NAV001NAV 001
02

Targets

TOP2A (DNA topoisomerase II)Mesothelin

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