LegoChem Bio receives FDA approval for phase 1,2 trials of LCB84

South Korean pharmaceutical firm LegoChem Biosciences Inc. announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) to initiate phase 1 and 2 clinical trials of its antibody-drug conjugate (ADC) LCB84 targeting Trophoblast cell surface antigen 2 (TROP-2).

The trial will be conducted in the US and Canada. It will assess the efficacy and safety of LCB84 as a single agent and in combination with an immunotherapy drug in about 300 patients with advanced solid tumors, including triple-negative breast cancer and colorectal cancer.

LCB84 targets the truncated form of the TROP2, a transmembrane glycoprotein that is expressed in a variety of tumor types, including breast cancer, colorectal cancer, and lung cancer. LegoChem Biosciences presented the preclinical results of LCB84 at the World ADC 2023 conference in London in March. It confirmed the efficacy of LCB84 in refractory cancer cells that did not respond to competing drugs. No significant toxicity was observed in normal cells expressing TROP2.

"LCB84 is the first ADC developed by LegoChem Biosciences to be independently developed in clinical trials. We will enter into self-led clinical trials with more than one new drug candidate every year in the future," Kim Yong-ju, CEO of LegoChem Biosciences, stated.

Write to Woo-Sang Lee at idol@hankyung.com