NewgLab Pharma to Complete Korea-US-Japan IND Applications Next Month... "Global Phase 2 Trial of Lung Cancer Treatment to Begin in Earnest"

[Asia Economy Reporter Jang Hyowon] Newgelab Pharma announced on the 16th that the global Phase 2 clinical trial of the non-small cell lung cancer treatment "Taletrectinib," licensed last year from the U.S. biotech company AnHeart Therapeutics (hereinafter AnHeart), is expected to be fully underway following the Investigational New Drug (IND) application.

"Taletrectinib" has attracted attention as a drug that showed one case of complete remission in a Phase 1 trial conducted in Japan.

Newgelab Pharma plans to complete the IND submissions for South Korea, the U.S., and Japan for the non-small cell lung cancer treatment "Taletrectinib" by next month, starting with the IND application for the global Phase 2 clinical trials in the U.S. and Japan by AnHeart. The domestic IND submission will be made by Newgelab Pharma to the Ministry of Food and Drug Safety (MFDS).

Taletrectinib has already been undergoing a Phase 2 clinical trial in China since last year. Once this IND application is approved, Phase 2 clinical trials will be conducted in a total of four countries to verify the safety and efficacy of Taletrectinib.

Taletrectinib is a therapeutic candidate that inhibits mutations in "ROS1-positive non-small cell lung cancer" and "NTRK-positive solid tumors." Phase 1 clinical trials conducted in the U.S. and Japan with 61 patients demonstrated safety and efficacy in patients with ROS1 mutations and those resistant to the standard ROS1 treatment drug Zelboraf (crizotinib).

The Taletrectinib clinical trials are planned to be conducted in South Korea, China, the U.S., Japan, and Europe, with Newgelab Pharma responsible for the Phase 2 trial in South Korea.

Shin Young Han, Head of Clinical Division at Newgelab Pharma, said, "Taletrectinib showed one case of complete remission in the Phase 1 trial conducted in Japan. In particular, since the drug has proven effective in treating brain metastases by crossing the blood-brain barrier (BBB), it not only has the potential to replace the currently only marketed lung cancer targeted therapy Zelboraf but also shows efficacy in patients resistant to Zelboraf, indicating significant growth potential."

He added, "Through the licensing agreement, Newgelab Pharma has secured all rights related to the commercialization of Taletrectinib. We plan to recognize related sales by obtaining conditional approval as soon as Phase 2 is completed and aim to complete the global clinical trials in the shortest possible time."