NewG Lab Completes Pre-IND Application to US FDA for Liver Cancer Treatment Drug

[Asia Economy Reporter Yoo Hyun-seok] Newgelab announced on the 16th that its U.S. subsidiary Newgelab Pharma has applied to the U.S. Food and Drug Administration (FDA) for a Pre-IND (pre-Investigational New Drug) meeting regarding the liver cancer treatment KAT (Ko Anti-cancer Technology) currently under development.

The Pre-IND meeting is a procedure in which the development details of a new drug candidate are mutually reviewed and coordinated with the FDA to increase the likelihood of clinical trial approval success. Recently, global CROs (Contract Research Organizations) have mainly chosen this approach.

KAT is a novel metabolic anticancer drug candidate that uses 3BP (3-Bromopyruvate) to inhibit and block the metabolic processes of cancer cells, selectively inducing apoptosis only in cancer cells. Dr. Younghee Ko, a Korean-American scientist from Johns Hopkins University and CEO of Newgelab Pharma, is leading the development and clinical trials of KAT.

A Newgelab official stated, “Since KAT targets the metabolic processes common to most cells, its efficacy has been demonstrated in most solid tumors,” and added, “The reason Newgelab chose liver cancer as the first project for metabolic anticancer drug development is because it has high economic feasibility and actual human treatment cases, making the probability of success the highest.”

Although liver cancer is a rare cancer in the United States, it is a common cancer type in Asian regions such as Korea, China, and Japan, ranking as the second leading cause of cancer-related deaths. Newgelab plans to conduct joint global clinical trials in Korea, where patient recruitment is relatively easier, and in the U.S., where it has received orphan drug designation, to expedite the clinical process.

Newgelab Pharma obtained ODD (Orphan Drug Designation) for liver cancer and cholangiocarcinoma in 2020, allowing it to apply for conditional approval after Phase 2 approval to shorten the clinical trial period. Additionally, by pursuing license-out targeting the Chinese market, which accounts for a significant portion of liver cancer patients worldwide, it plans to secure economic feasibility in the Asian market.

The upcoming Pre-IND meeting will involve Premier Research, a world-class premier research company, participating as the clinical CRO.

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