Ligachem Bio to Present Posters on Global HER2-ADC Clinical Trials at ESMO 2025

Ligachem Bio announced on October 14 that a total of three clinical and preclinical research results will be presented at the European Society for Medical Oncology (ESMO) 2025, which will be held in Berlin, Germany from October 17 to 20 (local time).

At this year’s ESMO 2025, presentations will include interim results from the global Phase 1 clinical trial (NCT05872295) of the HER2 (human epidermal growth factor receptor 2)-ADC (antibody-drug conjugate) “LCB14” (partner code IKS014/FS-1502) in patients with solid tumors, interim results from a Phase 2 clinical trial in gastric cancer patients in China, and preclinical achievements of Nectin4 (epithelial cell surface protein)-ADC “LN-4305/LN-4311,” which is being co-developed with Nectin Therapeutics. The full abstracts of these presentations were released on the ESMO website on October 13.

The most notable clinical result is the global Phase 1 trial of HER2-ADC, which will be presented through its technology transfer partner, Iksuda Therapeutics (Iksuda). This is a non-randomized, open-label, multi-center clinical trial evaluating IKS014 in patients with locally advanced or metastatic solid tumors expressing HER2. At ESMO 2025, results from Part 1, the dose-escalation phase, will be released.

According to the released abstract, as of the cutoff in December of last year, no dose-limiting toxicity (DLT) was observed among 44 patients enrolled in four dose cohorts (40, 60, 90, and 120 mg/m²), and the maximum tolerated dose (MTD) was not reached. No severe adverse events were detected, and encouraging anti-tumor activity was observed at all dose levels. Partial responses (PR) were seen across various solid tumor indications, including breast, esophageal, ovarian, and gallbladder cancers, as well as in both HER2-positive and HER2-low tumors.

Detailed clinical results will be released through a poster presentation scheduled for October 19 (local time), and more recent data (as of July this year) will be included in the detailed findings.

The pipeline LN-4305/LN-4311, being presented for the first time at ESMO 2025, is under joint development with Nectin Therapeutics. Development is underway with two payloads, exatecan and MMAE, simultaneously, applying Ligachem Bio’s next-generation ADC platform and Nectin Therapeutics’ proprietary antibodies.

According to the released abstract, LN-4305 and LN-4311 demonstrated superior efficacy compared to Padcev (the approved Nectin4-ADC) in multiple Nectin4 high-expression cancer models, including triple-negative breast cancer (TNBC) and lung cancer. Furthermore, in Padcev-resistant models, single administration of LN-4305 or LN-4311 led to tumor suppression. In animal studies, the highest non-severely toxic dose (HNSTD) was more than 10 times higher than that of Padcev, and higher than all other clinical candidate compounds. Based on their potent anti-tumor activity, LN-4305 and LN-4311 are expected to become best-in-class next-generation ADCs among competing Nectin4-ADCs.

This content was produced with the assistance of AI translation services.