NewGLab Pharma, Next-Generation Anticancer Drug Developer

Heungkuk Securities Analysis Report

[Asia Economy Reporter Hyungsoo Park] Heungkuk Securities introduced on the 28th that Newgislab Pharma is developing a next-generation anticancer agent, a metabolic anticancer agent (KAT-101).

Newgislab Pharma is conducting clinical Phase 1/2a trials for the metabolic anticancer agent in Korea and the United States. Taletrectinib is also undergoing global Phase 2 clinical trials. The metabolic anticancer agent works by entering cancer cells and blocking cellular metabolism to prevent energy source production.

Researcher Nayoung Lee of Heungkuk Securities explained, "It restores the function of cell apoptosis (VDAC) inhibited by hexokinase 2 and induces cancer cell death," adding, "Newgislab Pharma is conducting clinical Phase 1/2a trials targeting liver cancer with the same design approved by the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety."

Lee said, "Phase 1 consists of three cohorts with different administration methods: IT injection around the target area using ultrasound, oral administration, and oral/IT combination," adding, "Follow-up is conducted every 8 weeks after administration, and the total administration period is 12 months."

He stated, "Newgislab Pharma plans to proceed with clinical Phase 2a trials of the metabolic anticancer agent independently, then apply for FDA conditional approval and license out for other indications."

Furthermore, he explained, "KAT-101 was designated as an orphan drug in the United States in 2020," adding, "After completing Phase 2 for liver cancer, the plan is to expand indications. So far, the only FDA-approved metabolic anticancer agent is Agios Pharmaceuticals' leukemia (AML) treatment ‘Idhifa’."

Lee said, "After completing Phase 1 clinical trials of Taletrectinib, Newgislab Pharma licensed the Korean rights and negotiation rights for Southeast Asia and Japan from the Chinese biotech company Anote Therapeutics," adding, "Taletrectinib secured positive data from Phase 1 clinical trials targeting ROS1-mutated non-small cell lung cancer patients and interim results of Phase 2 trials in China."

He emphasized, "It showed a high response rate in non-small cell lung cancer patients with brain metastases, and based on excellent data, Newgislab Pharma is expected to penetrate the first- and second-line treatment markets."

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