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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231023270273/en/
Website: https://iksuda.com/
View Korean version of this release
Contact
Iksuda Therapeutics
Dave Simpson
Chief Executive Officer
+44 (0) 191 6031680
info@iksuda.com
FTI Consulting (Financial Media and IR)
Simon Conway / Rob Winder
+44 (0) 20 3727 1000
Iksuda@fticonsulting.com
This news is a press release provided by Iksuda Therapeutics. Korea Newswire follows these editorial guidelines.
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2023년 10월 24일 16:25
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2022년 1월 10일 17:30