First-in-human trial is designed to determine recommended dose of IKS03, a CD19-directed antibody drug conjugate, for the subsequent dose-expansion

IKS03 is Iksuda’s second asset to begin clinical testing

Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, today announces the completion of dosing of its first patient with IKS03, a CD19-directed ADC, in a phase 1, first-in-human, clinical trial in patients with advanced B cell non-Hodgkin lymphoma.

This first-in-human study (https://clinicaltrials.gov/study/NCT05365659) will evaluate the safety, tolerability, preliminary antineoplastic activity, pharmacokinetics and pharmacodynamics of increasing dose levels of IKS03, and determine the recommended dose for dose-expansion. Efficacy will be further evaluated in disease-specific expansion cohorts. The study is currently enrolling patients across clinical sites in Italy, Spain, Australia, United States and Canada.

Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:

“With the first patient successfully completing the safety evaluation period with IKS03, Iksuda demonstrates its continued commitment to drive its differentiated ADCs through clinical proof of concept, further solidifying our position as a clinical-stage ADC-focused company. Although there have been advances in the treatment of non-Hodgkin lymphoma in recent years, there remains a significant unmet patient need, and we hope that IKS03 will be able to build on the potential benefit-risk profile suggested by the data generated in preclinical studies.”

About IKS03

IKS03 is a best-in-class CD19-targeting ADC delivering a tumour-activated prodrug pyrrolobenzodiazepine (PBD) which was licensed from LigaChem Biosciences (formerly LegoChem Biosciences) (https://iksuda.com/2020/05/licensing-agreement-with-legochem-biosciences/). Preclinical testing demonstrates best-in-class efficacy (vs in-clinic and marketed CD19-targeted therapies) in in vivo xenograft models and significantly raised maximum tolerated dose (MTD) in non-human primate disease models, demonstrating its potential to be the leading anti-CD19 therapy in B-cell cancers.

About Iksuda Therapeutics: www.iksuda.com

Iksuda Therapeutics is a clinical stage, UK-based biotechnology company focussed on the development of class leading antibody drug conjugates (ADCs) targeting difficult-to-treat haematological and solid tumours. Iksuda’s pipeline of ADCs is centred on a portfolio of prodrug DNA and protein alkylating payloads in combination with stable conjugation chemistries including its proprietary PermaLink^® platform. The Company’s design concepts for ADCs are now clinically validated to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250529137420/en/

For further information please contact:
Iksuda Therapeutics
Dave Simpson, Chief Executive Officer
Tel: +44 (0) 191 6031680
Email info@iksuda.com

FTI Consulting (Financial Media and IR)
Simon Conway / Rob Winder / Amy Byrne
Tel: +44 (0) 020 3727 1000
Iksuda@fticonsulting.com

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