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.

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.

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

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By GlobalData

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.