Iksuda Therapeutics announces first patient dosed in Phase 1 trial of IKS014 in patients with advanced solid tumours that express HER2

Study is designed to evaluate the safety and tolerability of increasing dose levels of the antibody drug conjugate, IKS014, to establish a recommended Phase 2 dose

IKS014 is the first of Iksuda’s ADCs to enter clinical trials

NEWCASTLE, England--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of class leading antibody drug conjugates (ADCs) with enhanced tumour specificity, today announces that the first patient has completed a first cycle of therapy with IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours. This follows positive data from Phase 1 clinical trials through Fosun Pharma, which is now progressing FS-1502 (IKS014) through Phase 2 and Phase 3 trials in China.

The open-label, interventional study (https://clinicaltrials.gov/study/NCT05872295) is designed to evaluate the safety and tolerability of increasing dose levels of IKS014 to establish a recommended Phase 2 dose. The second, dose-expansion, phase of the study (Phase 1b) is to further evaluate the safety, pharmacokinetics / pharmacodynamics, and efficacy of IKS014 at the recommended Phase 2 dose. The study is currently enrolling patients at five planned locations in Australia. The Phase 1b trial is expected to read out in 2H 2025.

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

“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.”

About IKS014

IKS014 is a potential best-in-class antibody drug conjugate, benefiting from tumour selective activation and release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, it displayed impressive activity in high- and low-HER2 expressing tumours with significantly higher non-severely toxic dose (HNSTD) vs other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LegoChem Biosciences. (https://iksuda.com/2022/01/iksuda-deepens-clinical-pipeline/) Fosun Pharma holds the licence to the ADC in Greater China where it is designated FS-1502. Fosun is currently conducting a Phase 2 clinical trial in China in patients with a range of solid tumours and has also initiated a Phase 3 trial in patients with advanced breast cancer.

About Iksuda Therapeutics: www.iksuda.com

Iksuda Therapeutics is a UK-based clinical stage biotechnology company focused on the development of class leading Antibody Drug Conjugates (ADCs) with enhanced tumour specificity, targeting difficult-to-treat cancers. Iksuda’s ADC design and pipeline is enabled by a broad armoury of payload mechanisms, tumour selective activation platforms and stable conjugation chemistries. The Company’s ADC portfolio is designed to significantly improve the therapeutic index of this important modality and improve the outcomes for patients living with cancer.