LG Chem said its U.S. partner Cue Biopharma received the FDA approval to conduct a phase 1 trial of CUE-102, an anti-cancer therapy targeting the Wilms Tumor-1 (WT-1) gene.
LG Chem owns the exclusive right to develop and market CUE-102 in 11 Asian countries, including Korea, China, and Japan.
With the FDA’s green light, Cue Biopharma will evaluate the drug’s safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in WT-1 positive gastric cancer, pancreatic cancer, ovarian cancer, and colorectal cancer patients.
CUE-102 is an immunotherapy candidate expected to selectively recognize WT-1 positive tumors and proliferate T cells within the body to kill the tumor cells.
CUE-102 will be distinguished from conventional T cell therapies that require extracting T cells outside the patient’s body, gene modification, proliferation, and reinjection back into the patient.
Based on the interim results of the phase 1 study of CUE-101, a preceding pipeline developed on the same platform, the upcoming U.S. phase 1 trial will evaluate dose escalation from 1mg/kg.
The evaluation of the effective dose in the phase 1 study of CUE-101 started with 0.06mg/kg and increased the dose to 1 mg/kg for about nine months.
LG Chem said it would use data from the phase 1 CUE-102 study to design a phase 2 trial in Asia and develop the drug directly.