NewgLab Pharma's US Subsidiary Receives Approval for Phase 2A+1 Clinical Trial of Liver Cancer Immunotherapy Agent

[Asia Economy Reporter Hyunseok Yoo] NewGLab Pharma's U.S. subsidiary, NewGLab Pharma, Inc., announced on the 31st that it has received approval from the U.S. Food and Drug Administration (FDA) for clinical Phase 2a+1 trials of its anti-cancer metabolic drug KAT (Ko Anti-cancer Technology) for liver cancer treatment.

This achievement was made three years after recruiting Dr. Younghee Ko, a Johns Hopkins University alumnus and the world's leading authority in the field of anti-cancer metabolic drugs, to start its new drug development business.

The clinical trial is designed as an "Open Label" study (a method in which both the subjects and investigators know whether the test drug or control drug is being used). This design allows for immediate confirmation of efficacy data during the trial.

The measurement indicators to be used include Objective Response Rate (ORR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS). Efficacy data such as complete remission, partial remission, and progression-free survival observed during the clinical process will be announced.

Since the anti-cancer metabolic drug KAT has already demonstrated efficacy through numerous emergency clinical treatment cases in liver cancer, bladder cancer, and others, the industry expects positive efficacy data to be announced soon.

KAT already holds Orphan Drug Designation from the FDA. Accordingly, the number of subjects and the FDA review period can be shortened, and early commercialization through accelerated approval is planned after completing Phase 2 clinical trials.

A NewGLab Pharma official stated, "Through this approval process, we were able to confirm the FDA's warm interest in anti-cancer metabolic drugs," and added, "We plan to submit a clinical trial plan to the Korean Ministry of Food and Drug Safety and conduct simultaneous clinical trials in Korea and the U.S."

KAT is a new anti-cancer drug candidate that uses a substance called 3BP (3-Bromopyruvate) to block the unique energy metabolism of cancer cells and selectively induce death only in cancer cells. Existing anticancer drugs work by binding to receptors or immune-specific substances on the outer membrane of cancer cells to kill them. KAT’s mechanism allows the drug to directly enter inside cancer cells. Therefore, while existing anticancer drugs vary in external receptors depending on the cancer type and are effective only for certain cancer types, KAT’s most significant feature is its ability to treat almost all cancer types.

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