Iksuda Therapeutics advances IKS014 in Phase 1 trial following positive initial results

Iksuda Therapeutics, a clinical-stage biotechnology firm from the UK specializing in innovative antibody drug conjugates (ADCs) for tumor specificity, reported successful completion of the first therapy cycle for IKS014. This ADC, targeting advanced HER2+ solid tumours, moves ahead following encouraging results from Phase 1 trials managed by Fosun Pharma. Fosun’s efforts have initiated further trials for FS-1502 (IKS014) in both Phase 2 and Phase 3 stages within China.

Key Details of IKS014 Clinical Trials

The current open-label interventional study aims to understand the safety and acceptability of increasing IKS014 dose levels, aiming to define the recommended dose for Phase 2. As this trial proceeds, its secondary phase (Phase 1b) will delve deeper into the safety metrics, pharmacokinetics, and overall efficacy of IKS014. This segment of the trial is currently enlisting participants across five predetermined locations in Australia, with results anticipated for the second half of 2025.

Dr. Dave Simpson, Iksuda Therapeutics’ Chief Executive Officer, expressed, “The dosing of the first patient in our Phase 1 trial of IKS014 marks a significant milestone for Iksuda: our transition to being a clinical-stage company. We hope that this trial of IKS014 could lead to improved treatment options for patients with HER2+ solid tumours.”

Promising Characteristics of IKS014

With attributes like tumor-specific activation, IKS014 emerges as a potential leader among ADCs. This feature is chiefly because of the controlled release of the cytotoxic agent, monomethyl auristatin F (MMAF). Preclinical investigations have showcased IKS014’s commendable activity against both high and low HER2 expressing tumours, especially noting its elevated non-severely toxic dose (HNSTD) when compared to other HER2-oriented medications. Worldwide rights (excluding regions of Greater China and South Korea) for IKS014 were secured by Iksuda from LegoChem Biosciences.

Fosun Pharma’s Concurrent Trials

Apart from Iksuda’s endeavors, Fosun Pharma maintains the license for this ADC in the Greater China region, denoting it as FS-1502. Presently, Fosun is deep into a Phase 2 clinical trial for a variety of solid tumours. Additionally, a Phase 3 trial targeting advanced breast cancer patients is also in its initial stages.