Iksuda Therapeutics Secures FDA IND Clearance for IKS014 Targeting HER2-Positive Solid Tumours
Tuesday, July 01, 2025
Iksuda Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for IKS014, an antibody-drug conjugate (ADC) designed to target HER2-positive solid tumours. This approval will enable the company to expand its ongoing Phase 1 clinical trial into centres across the United States.
IKS014 is currently being assessed in an open-label Phase 1 dose-escalation study aimed at evaluating its safety, tolerability, and identifying a recommended dose for Phase 2. Early clinical results have shown promising anti-tumour activity in a range of cancer types, including breast, ovarian, gallbladder, and oesophageal cancers—particularly in patients who have previously received and relapsed on therapies such as Enhertu.
The upcoming expansion stage of the trial will involve patient groups with HER2-positive breast cancer who are resistant or intolerant to Enhertu, HER2-low breast cancer, and HER2-positive gastric cancer. With the IND clearance, Iksuda will now be able to enrol patients in the U.S. in addition to existing trial locations in Australia, New Zealand, and Singapore. The Phase 1 study is expected to complete in the second half of 2026.
IKS014 is engineered to selectively deliver the cytotoxic agent monomethyl auristatin F (MMAF) to tumour cells. Preclinical studies suggest that it has strong activity in both high and low HER2-expressing cancers, with a favourable therapeutic index compared to other HER2-targeting treatments.
Iksuda holds global rights to IKS014 outside of Greater China and South Korea, having licensed the candidate from LigaChem Biosciences.
Source: businesswire.com
