LegoChem Submits IND for ADC 'LCB84' Phase 1 and 2 to US FDA

LegoChem Biosciences is accelerating preparations for human clinical trials of 'LCB84,' an antibody-drug conjugate (ADC) targeting tumor-related calcium signal transducer (TROP)-2.

On the 23rd, LegoChem Biosciences announced on the 24th that it had submitted an Investigational New Drug (IND) application for Phase 1 and 2 clinical trials of LCB84 to the U.S. Food and Drug Administration (FDA). The clinical trial will be conducted in two stages involving approximately 300 patients with various solid tumors, including breast and lung cancers, in the United States and Canada. The first stage is a dose escalation phase, and the second stage is a dose expansion phase. The company expects the clinical trial to take about five years after receiving approval from the Institutional Review Board (IRB).

TROP-2 is a protein overexpressed in many solid tumors such as triple-negative breast cancer (TNBC), non-small cell lung cancer, bladder cancer, and pancreatic cancer. However, since it is also expressed in normal cells, targeting it for anticancer therapy has been challenging. LCB84 enhances safety by using an antibody targeting the 'cleaved form of TROP-2,' which LegoChem Biosciences acquired from Italy's Mediterrania Theranostics in 2021. Hyunsoo Ha, a researcher at Yuanta Securities, analyzed, "Although TROP-2 is expressed in normal cells, the cleaved form of TROP-2 is mainly expressed in tumor cells," adding, "LCB84 is expected to selectively act on tumor cells." Currently, TROP-2-targeting ADCs such as Gilead's Trodelvy and Daiichi Sankyo-AstraZeneca's DS-1062 are under development.

In the dose escalation phase of this clinical trial, the safety and tolerability of LCB84 alone and in combination with immune checkpoint inhibitors will be evaluated across various solid tumors to determine the Phase 2 dosing. This phase consists of dose escalation cohorts of LCB84 as a single agent (Group A) and in combination with immune checkpoint inhibitors (Group B) to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy. Subsequently, the dose expansion phase will evaluate the preliminary efficacy of LCB84 alone and in combination with immune checkpoint inhibitors in selected solid tumors, as well as further confirm safety and tolerability. This phase will consist of dose expansion cohorts evaluating LCB84 as a single agent and in combination with immune checkpoint inhibitors in selected tumor types.

Notably, this clinical trial is expected to be led by AntibodyChem Biosciences (ACB), the U.S. branch established in March last year. The branch is headed by Jaeuk Chae, Vice President of Business Strategy at LegoChem Biosciences, who has led multiple technology licensing deals at the company.

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