[Asia Economy Reporter Jang Hyowon] NewG Lab Pharma announced on the 26th that its drug development subsidiary, NewG Lab Therapeutics, is smoothly progressing with the domestic Phase 2 clinical trial of the non-small cell lung cancer treatment drug, Taletrectinib. Following the first patient enrollment for Taletrectinib at the end of last year, NewG Lab Therapeutics recently enrolled the second patient and is currently administering the treatment.
In September of last year, NewG Lab Therapeutics received approval from the Ministry of Food and Drug Safety (MFDS) for the domestic Phase 2 clinical trial of the lung cancer treatment drug Taletrectinib. The first and second patients were registered at Seoul Asan Medical Center, and the clinical trial sites are expanding to a total of five locations, including Korea University Hospital, Pusan National University Hospital, and Hwasun Jeonnam National University Hospital.
Taletrectinib is an anticancer drug candidate that blocks and inhibits the activation of ‘ROS-1’ and ‘tyrosine receptor kinase (NTRK) gene fusion variant proteins’ found in various solid tumors including non-small cell lung cancer, thereby preventing cancer metastasis and eliminating tumors.
During the global Phase 1 clinical trial, Taletrectinib demonstrated cases of complete remission where the cancer was entirely eliminated, as well as the ability to cross the blood-brain barrier (BBB) and suppress metastatic brain tumors. Additionally, in the Chinese Phase 2 clinical trial, the objective response rate (ORR) was 90.5% in treatment-naive patients and 43.8% in patients with resistance to Xalkori.
This result is superior to the objective response rate (72%) recorded by Pfizer’s Xalkori at the time of its approval by the U.S. Food and Drug Administration (FDA). Based on these clinical trial results, Taletrectinib is expected to be a sufficient alternative for patients who have developed resistance to Xalkori, the standard treatment for non-small cell lung cancer.
A representative from NewG Lab Pharma stated, “Since Taletrectinib showed successful results in global Phase 1 and 2 clinical trials, we expect the domestic Phase 2 trial to be successful as well,” adding, “After completing the domestic Phase 2 trial, we plan to rapidly proceed with commercialization by utilizing the orphan drug designation system.”
Taletrectinib is undergoing global Phase 2 clinical trials simultaneously in South Korea, the United States, Japan, and China. In the U.S. and Japan, the U.S.-based Anhui Therapeutics is conducting the Phase 2 trials. In China, Innovent Biologics, listed on the Hong Kong Stock Exchange, is conducting the Phase 2 trials.
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