Iksuda Therapeutics, a UK-based clinical-stage biotechnology company, will present new Phase 1 data for its HER2-targeting antibody drug conjugate IKS014 at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, taking place October 17-21, 2025.
Phase 1 Study Design and Objectives
The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. The data presentation will focus on the dose escalation portion of the trial conducted in Australia, which was designed to establish the Maximum-tolerated dose and/or Recommended Phase 2 Dose for IKS014 as monotherapy.
The study aims to provide initial safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity characteristics of the ADC. The poster presentation is scheduled for October 19, 2025, from 12:00-12:45 CET in Level 2, Hall 25, under poster number 936P.
IKS014 Mechanism and Preclinical Performance
IKS014 is positioned as a potential best-in-class antibody drug conjugate that benefits from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, IKS014 displayed impressive activity in both high- and low-HER2 expressing tumours with a favourable Therapeutic Index compared with other HER2-directed drugs.
Iksuda gained exclusive worldwide rights to IKS014 from LigaChem Biosciences, excluding Greater China and South Korea. The licensing agreement expands Iksuda's clinical pipeline of ADCs targeting difficult-to-treat haematological and solid tumours.
Company's ADC Platform Strategy
Iksuda Therapeutics focuses on developing class-leading antibody drug conjugates targeting difficult-to-treat haematological and solid tumours. The company's pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries, including its proprietary PermaLink platform.
According to the company, its design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve outcomes for patients living with cancer.
