On June 30, 2025 Iksuda Therapeutics (Iksuda), the developer of class-leading antibody drug conjugates (ADCs) with clinically validated tumour-selective payload release formats, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours, enabling the expansion of ongoing clinical trials (Press release, Iksuda Therapeutics, JUN 30, 2025, View Source [SID1234654184]).
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IKS014 is currently being investigated in an open-label phase 1 dose-escalation study (View Source) designed to evaluate the safety and tolerability of increasing dose levels of IKS014 and establish a recommended phase 2 dose. Preliminary data from this study has demonstrated promising clinical activity across multiple tumour types, including breast, ovarian, gallbladder, and oesophageal cancers, and including patients who have relapsed after prior treatment with Enhertu. Gaining access to U.S. centres for the dose expansion stage of this phase 1 trial will enable efficient confirmation of the role of IKS014 in this important patient sub-set.
Dr Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, said:
"The FDA clearance of our IND application for IKS014 represents a significant milestone in our mission to address the critical unmet needs of patients with HER2-positive cancers, particularly those who have exhausted current standard-of-care options. Early clinical data has been extremely encouraging, and we are excited to expand our program to reach more patients.
"The early efficacy signals that have been observed, particularly in patients that have relapsed after receiving prior treatments of Kadcyla and Enhertu, suggest IKS014 could potentially offer a new treatment option for patients who currently have limited alternatives. We look forward to working with our clinical partners to further evaluate the potential of IKS014."
The first stage of this phase 1 trial, to determine the recommended phase 2 dose for dose expansion, is nearing completion. The expansion phase will assess several patient cohorts including those with HER2-positive breast cancer who are refractory to or cannot tolerate Enhertu, patients with HER2-low breast cancer and patients with HER2-positive positive gastric cancer. The IND clearance will allow Iksuda to access patients across sites in the United States, alongside sites in Australia, New Zealand, and Singapore. The phase 1 trial is expected to complete in 2H 2026.
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 a favourable Therapeutic Index vs other HER2-directed drugs. Iksuda gained exclusive world-wide rights (excluding Greater China and South Korea) to IKS014 from LigaChem Biosciences (View Source).