NewgLabPharma US Subsidiary Applies for FDA Phase 1/2a Clinical Trial of Liver Cancer Immunotherapy Agent

[Asia Economy Reporter Hyunseok Yoo] NewGLab Pharma announced on the 23rd that its subsidiary in the United States, NewGLab Pharma, Inc., has submitted a clinical trial protocol for Phase 1/2a studies to the U.S. Food and Drug Administration (FDA) to gain approval for the anti-cancer agent ‘KAT (Ko Anti-cancer Technology)’ as a treatment for liver cancer.

The clinical trials are planned to be conducted simultaneously in the United States and Korea, aiming to verify not only the safety of KAT but also its efficacy against liver cancer. A separate clinical trial protocol will be submitted to the Korean Ministry of Food and Drug Safety (MFDS).

KAT targets the universal metabolic processes of cells, and preclinical studies have confirmed its efficacy in most solid tumors. The company explained that through this clinical trial, they will first demonstrate efficacy in liver cancer and then gradually expand the indications.

KAT is a novel anti-cancer agent that selectively induces death in cancer cells by blocking the unique energy metabolism of cancer cells using a chemical compound called ‘3BP (3-Bromopyruvate).’ It reduces the toxicity and resistance drawbacks of first-generation chemotherapy, second-generation targeted therapy, and third-generation immunotherapy, while significantly improving response rates, making it a promising next-generation anti-cancer drug.

A representative from NewGLab Pharma stated, “Last year, KAT was designated as an orphan drug by the U.S. FDA for liver and bile duct cancers, allowing conditional approval after Phase 2 clinical trials. This shortens the commercialization timeline, which is why liver cancer was chosen as the first clinical indication.”

They added, “We plan to conduct clinical trials in collaboration with leading hospitals in the U.S. and Korea. In particular, pharmaceutical companies in China, which accounts for about half of the world’s liver cancer patients, have also expressed interest in KAT,” opening the possibility for technology export.

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