LigaChem Biosciences said Tuesday that its U.K. partner, Iksuda Therapeutics, has received U.S. FDA approval to expand its global phase 1 IND for IKS014, a HER2-ADC with “best-in-class” potential.

IKS014 is a potential “best-in-class” HER2-ADC utilizing LigaChem Bio's ADC platform, ConjuALL, and MMAF payload (DAR = 2).

IKS014 is undergoing an open-label, phase 1 dose-escalation study to evaluate safety and tolerability across dose groups and determine the recommended phase 2 dose (RP2D).

Initial clinical results demonstrated promising clinical efficacy in various solid tumors, including breast, ovarian, gallbladder, and esophageal cancers, with particularly impressive efficacy results in patients who had previously received Enhertu and relapsed.

With the approval of this phase 1 IND expansion, the upcoming dose-expansion study will expand the clinical geography beyond Australia to include the U.S., Singapore, and other regions.

According to Iksuda, the ongoing phase 1 dose-escalation study is nearing completion, and the subsequent dose-escalation study will involve multiple patient cohorts.

These cohorts will include patients with HER2-positive breast cancer, HER2-low breast cancer, and HER2-positive gastric cancer, including patients who are Enhertu refractory or resistant. The IND expansion will expand the study to a multicenter, multinational study in the U.S., Australia, New Zealand, and Singapore, with accelerated patient recruitment to complete the trial in the second half of next year.

LigaChem Bio’s Chinese partner, Fosun Pharmaceutical, expects to complete its Chinese license application for the drug by the end of the year.

LigaChem Bio plans to host the LigaChem Bio Global R&D Day 2025, a one-day hybrid event, where it will present the initial phase 1 results of IKS014 for the first time