Newcastle-based Iksuda Therapeutics has announced a key clinical milestone with the dosing of the first patient in its Phase 1 trial of IKS03, a CD19-targeting antibody-drug conjugate (ADC) developed for patients with advanced B cell non-Hodgkin lymphoma (NHL).
The trial marks Iksuda’s second ADC to enter clinical development, reinforcing the company’s position as a UK leader in next-generation ADC therapeutics. IKS03, a first-in-human candidate, will be evaluated for safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumour activity in a multi-centre dose-escalation study. The aim is to establish a recommended Phase 2 dose for further evaluation in disease-specific patient cohorts.
The study is actively enrolling across international sites, including the US, Canada, Italy, Spain, and Australia.
Dr Dave Simpson, CEO of Iksuda Therapeutics, commented: “We’re proud to confirm that the first patient has completed the initial safety evaluation period in the IKS03 study. This milestone underscores Iksuda’s evolution as a clinical-stage ADC company and reflects our ongoing commitment to developing highly selective, tumour-targeted therapies. Despite progress in NHL treatment, significant unmet need persists. We believe IKS03 can help address that gap.”
Iksuda’s ADC platform is built around tumour-selective payload release technology, designed to maximise therapeutic efficacy while reducing off-target toxicity, addressing a major limitation of earlier ADC generations. With a growing pipeline, Iksuda continues to contribute to the UK’s prominence in oncology innovation and highlights the North East of England’s emerging role in the global biotech landscape.
