Iksuda Therapeutics, a biotechnology company focused on next-generation antibody drug conjugates (ADCs), has announced that preliminary data from its Phase 1 clinical study of IKS014 will be presented at the 2026 ASCO Gastrointestinal Cancers Symposium, scheduled to be held in San Francisco from 8–10 January. The presentation will highlight early evidence of clinical activity in patients with oesophageal cancer enrolled in an ongoing Phase 1, open-label, multicentre trial (NCT05872295).
The study is assessing IKS014, a HER2-targeted ADC, in patients with locally advanced or metastatic HER2-expressing solid tumours. The trial is designed to determine the maximum tolerated dose or recommended Phase 2 dose, while also evaluating safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy.
The data to be shared includes results from an unplanned subgroup of patients with oesophageal cancer enrolled during the dose-escalation stage of the study conducted in Australia. As of July 2025, 62 patients had received IKS014 across five dose levels, including 10 individuals with HER2-positive oesophageal cancer. Signs of anti-tumour activity were observed across multiple tumour types, including breast, ovarian, lung, gallbladder and oesophageal cancers, in both HER2-positive and HER2-low settings.
Among the oesophageal cancer cohort, five patients experienced objective responses, while three achieved prolonged disease stabilisation, resulting in a clinical benefit rate of 80%. Based on these findings, the study will now expand to include a dedicated cohort of patients with HER2-expressing oesophageal adenocarcinoma who have previously received standard treatment.
Iksuda Therapeutics is a UK-based, clinical-stage biotechnology company developing best-in-class antibody–drug conjugates (ADCs) for the treatment of hard-to-treat haematological malignancies and solid tumours. The company’s ADC pipeline is built around a portfolio of prodrug ADCs that enable tumour-selective payload release and activation, combined with highly stable conjugation chemistries, including its proprietary PermaLink® platform.
Iksuda’s early-stage pipeline also features its proprietary protein-alkylating payload class, ProAlk™. Together, these clinically validated design approaches have demonstrated the potential to significantly enhance the therapeutic index of ADCs and improve outcomes for patients with cancer.
