The FDA has approved Iksuda Therapeutics' IND application for IKS014, a HER2-targeted antibody drug conjugate, allowing expansion of ongoing Phase 1 clinical trials to include US sites alongside existing locations in Australia, New Zealand, and Singapore.
Preliminary clinical data from the dose-escalation study demonstrates promising activity across multiple solid tumor types including breast, ovarian, gallbladder, and esophageal cancers, with notable efficacy in patients who relapsed after prior Enhertu treatment.
The Phase 1 trial is nearing completion of its dose-escalation phase and will proceed to expansion cohorts targeting HER2-positive breast cancer patients refractory to Enhertu, HER2-low breast cancer patients, and HER2-positive gastric cancer patients.
IKS014 utilizes a tumor-selective payload release mechanism with monomethyl auristatin F (MMAF) and showed impressive preclinical activity in both high- and low-HER2 expressing tumors with a favorable therapeutic index.