Drug intelligence / Profile preview

NEOK001

Development stage
Phase 1
Lead developer
NEOK Bio
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

NEOK001 is a bispecific antibody-drug conjugate (ADC) developed for oncology, designed to simultaneously target **B7-H3 (CD276)** and **ROR1 (Receptor Tyrosine Kinase-Like Orphan Receptor 1)**, both of which are involved in immune evasion and oncogenic signaling and are broadly expressed across multiple solid tumor types. NEOK001 uses a **topoisomerase I inhibitor payload** (specifically, an exatecan-based SYNtecan E linker-payload licensed from Synaffix/Lonza) to improve tumor selectivity, internalization, and efficacy while aiming to reduce off-tumor toxicity relative to monovalent ADCs. The rationale for the dual-targeting approach is to require co-expression of both B7-H3 and ROR1 on tumor cells, which is expected to enhance cancer cell selectivity and allow higher dosing. NEOK001 is being developed primarily for solid tumors, including thoracic, gastrointestinal, and gynecological cancers. The lead is advancing towards IND submission in early 2026, with first-in-human trials planned for mid-2026[3][5][6][8][10][14].

02

Targets

ROR1 (Receptor tyrosine kinase-like orphan receptor 1)B7-H3

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