Iksuda Therapeutics, a company specializing in the development of innovative antibody drug conjugates (ADCs) with enhanced tumor specificity, has announced a significant milestone in its clinical trials. The first patient has successfully completed the initial treatment cycle of IKS014, an antibody-drug conjugate targeting the human epidermal growth factor receptor 2 (HER2) in advanced HER2+ solid tumors. Notably, Fosun Pharma's phase 1 clinical trial had previously yielded positive results, and they are currently advancing to phase 2 and phase 3 trials of FS-1502 (IKS014) in China.

The clinical trial, registered as an open-label, interventional study on ClinicalTrials.gov under the identifier NCT05872295, is primarily designed to assess the safety and tolerability of escalated doses of IKS014. This data will help determine the recommended dosage for the upcoming Phase 2 trials. The subsequent phase of the study (Phase 1b) will focus on dose expansion and will further investigate the safety, pharmacokinetics/pharmacodynamics, and effectiveness of IKS014 at the recommended Phase 2 dosage. Currently, patient recruitment is underway at five designated study sites in Australia, and Phase 1b trials are anticipated to commence in the latter half of 2025.

Iksuda Therapeutics, expressed the importance of this milestone, saying, "The initiation of the IKS014 Phase 1 trial with the first patient receiving the investigational drug is a significant step forward for Iksuda as we transition into a clinical-stage company. We aspire to enhance treatment options for patients battling HER2+ solid tumors."

IKS014 represents a potential best-in-class antibody-drug conjugate distinguished by its tumor-selective activation mechanism and the controlled release of the cytotoxic agent monomethyl auristatin F (MMAF). In preclinical trials, IKS014 demonstrated remarkable efficacy in both high and low HER2-expressing tumors while exhibiting a considerably higher non-severe toxic dose (HNSTD) compared to other HER2-targeted agents. Iksuda acquired the exclusive worldwide rights to IKS014 (excluding Greater China and South Korea) from LegoChem Biosciences. Fosun Pharma holds the licensing rights for the ADC in Greater China, where it is known as FS-1502. Fosun Pharma is currently conducting Phase 2 clinical trials for various solid tumors in China and has initiated a Phase 3 trial for patients with advanced breast cancer.

 

Source: businesswire.com

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