The Phase I trial will assess IKS014 in advanced HER2+ solid tumour patients. Credit: CI Photos / Shutterstock.

UK-based biotechnology company Iksuda Therapeutics has dosed the first subject in a Phase I trial of IKS014 in patients with advanced solid tumours expressing human epidermal growth factor receptor 2 (HER2+) mutation.

The first patient in the trial has received the first cycle of treatment with IKS014.

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The interventional, open-label study will assess the tolerability and safety of rising dose levels of IKS014 to establish a recommended dose for the Phase II trial (RP2D).

Following this, Iksuda will assess the efficacy, safety, pharmacokinetics and pharmacodynamics of the RP2D of IKS014 in a dose-expansion part (Phase Ib) of the study.

Subject enrolment is currently underway at five planned sites in Australia.

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Iksuda expects to report data from the Phase Ib trial in the second half of 2025.

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Iksuda Therapeutics CEO Dr Dave Simpson said: “The dosing of the first patient in our Phase I 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.”

A HER2-targeting antibody-drug conjugate (ADC), IKS014 is the first of the company’s ADCs to enter the clinic.

Iksuda said that IKS014 had shown ‘impressive’ activity in high and low-HER2 expressing tumours, with significantly higher non-severely toxic doses compared with other HER2-directed drugs.

The company recently reported positive findings from Phase I clinical trials of the ADC in China through Fosun Pharma, which is advancing FS-1502 (IKS014) in Phase II and III trials in China.

Based in Newcastle-upon-Tyne, Iksuda Therapeutics aims to design and develop ADCs for cancer patients, especially those with limited treatment options.

The company’s ADC design principles are based on several in-house platforms, including novel linkers, numerous payload series and stable bioconjugation platforms.