Iksuda Therapeutics, Partner of LigaChemBio, Receives FDA IND Expansion Approval for Phase 1 Study of HER2-ADC

- IND expansion approval obtained to accelerate the upcoming dose-expansion study and enhance commercial potential

- Trial to include patients with resistance or relapse to Enhertu, underscoring high commercial value

- Multinational, multi-center clinical trial to be conducted in the U.S., Australia, Singapore, etc., aiming for study completion by 2026

LigaChem Biosciences Inc. (KOSDAQ: 141080, “LigaChemBio”) announced that its partner, Iksuda Therapeutics (“Iksuda”), has received expanded Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the global Phase 1 clinical trial of its HER2-targeting antibody-drug conjugate (ADC), IKS014, which was licensed from LigaChemBio.

IKS014 is a HER2-ADC with best-in-class potential, incorporating LigaChemBio’s proprietary ADC platform ConjuALL and an MMAF payload with a drug-to-antibody ratio (DAR) of 2.

The compound is currently being evaluated in an open-label, dose-escalation Phase 1 study to assess safety, tolerability, and determine the recommended Phase 2 dose (RP2D). Initial clinical findings have demonstrated promising anti-tumor activity in various solid tumors, including breast, ovarian, gallbladder, and esophageal cancers. Notably, the study has shown impressive efficacy even in patients who relapsed after prior treatment with Enhertu (trastuzumab deruxtecan).

With the latest IND expansion approval, the upcoming dose-expansion part of the trial will be extended beyond Australia to include new sites in the United States and Singapore. Entry into U.S. clinical centers is expected to allow more efficient validation of IKS014’s efficacy in key patient groups, particularly those who relapsed after Enhertu—critical for eventual commercialization.

According to Iksuda, the ongoing dose-escalation portion of the Phase 1 trial is nearing completion. The dose-expansion phase will evaluate multiple patient cohorts, including those with HER2-positive breast cancer, HER2-low breast cancer, and HER2-positive gastric cancer. Importantly, patients with resistance or non-response to Enhertu will be included. The expanded IND allows for a multinational, multi-center study across the U.S., Australia, New Zealand, and Singapore, aiming to accelerate patient enrollment and complete the trial by the second half of 2026. Separately, LigaChemBio’s Chinese partner, Fosun Pharmaceuticals, is preparing to submit a regulatory application for IKS014 in China within the year.

Meanwhile, LigaChemBio is hosting its “LigaChemBio Global R&D Day 2025” both offline and online today (July 1), where the initial results from the IKS014 Phase 1 trial will be presented for the first time.

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