Drug intelligence / Profile preview

ARC-101

Development stage
Preclinical
Lead developer
Araris Biotech
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

ARC-101 (also known as ARA-04-RKAA-PABC-MMAE) is a preclinical-stage, site-specific antibody-drug conjugate (ADC) developed by Araris Biotech (a subsidiary of Taiho Pharmaceutical) targeting Nectin-4. Built using Araris' proprietary AraLinQ conjugation platform, the drug consists of an anti-Nectin-4 monoclonal antibody (derived from enfortumab) enzymatically conjugated to the microtubule-disrupting cytotoxin monomethyl auristatin E (MMAE) via a hydrophilic RKAA peptide linker. This site-specific conjugation occurs at a privileged glutamine residue (Q295) within the antibody's Fc framework, yielding a highly homogeneous ADC with a drug-to-antibody ratio (DAR) of approximately 2. Preclinical studies demonstrate that ARC-101 possesses superior serum stability, an antibody-like pharmacokinetic profile, and enhanced anti-tumor efficacy with a significantly improved therapeutic index compared to enfortumab vedotin.

Other names
Araris anti-Nectin-4 ADCAraris Nectin-4 MMAE ADC
02

Targets

TUBB (Tubulin (alpha and beta subunits))PVRL4 (Nectin cell adhesion molecule 4)

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