NewGLab Pharma US Subsidiary Advances KAT-Keytruda Combination Clinical Trial

[Asia Economy Reporter Hyungsoo Park] NewGLab Pharma, Inc., a U.S. company, announced on the 18th that it plans to start preclinical trials of the combination therapy of KAT and Keytruda in animals.

Based on the preclinical trial results, NewGLab Pharma plans to pursue joint clinical trials of the combination therapy with MSD, the developer of Keytruda.

NewGLab Pharma is developing the metabolic anticancer agent KAT. Having received FDA approval, it is currently conducting Phase 1+2a clinical trials of KAT as a monotherapy targeting liver cancer. Separately, it is also preparing combination therapy trials with Keytruda.

Before administration to humans, the safety and efficacy of the combination therapy will be confirmed through animal (mouse) experiments. The research team led by Professor Woochan Son at the Center for Nonclinical Development (CND) of Asan Medical Center in Seoul is conducting the study. Through the preclinical combination therapy, NewGLab Pharma aims to increase the treatment rate of cancer patients while absorbing Keytruda’s market share to maximize the commercial value of KAT.

Keytruda is approved in South Korea for 18 indications across 14 cancer types. Globally, it is a blockbuster drug with annual sales exceeding 17 trillion KRW. NewGLab Pharma planned this study with Professor Woochan Son’s team based on basic research data obtained in the U.S. It is expected that the response rate and therapeutic effect of Keytruda can be further enhanced through combination therapy with KAT.

KAT directly enters cancer cells and blocks their energy sources, resulting in high therapeutic efficacy and strong resistance to tolerance and mutation. Last year, NewGLab Pharma received FDA approval for Phase 1 and 2a clinical trials of KAT as a monotherapy targeting liver cancer and is currently conducting clinical trials. In addition to the existing monotherapy trials, it expects to further increase the utility of KAT through additional combination therapy trials.

A NewGLab Pharma official said, "Although KAT shows sufficient therapeutic effects as a monotherapy, we expect to create synergy that improves the quality of anticancer treatment by combining it with Keytruda, which is currently the most widely used."

He added, "KAT has a mechanism that is similarly applicable to all cancer types. We will continuously expand KAT’s indications through monotherapy and combination therapy to realize the new drug development goal of ensuring quality of life for cancer patients."

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