Bridge Biotherapeutics said that the Ministry of Food and Drug Safety has given the green light to its investigational new drug (IND) application of BBT-176, a non-small-cell lung carcinoma (NSCLC) treatment.

BBT-176 is a novel epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that hinders the signaling pathway of EGFR with C797S mutations, which arise from resistant mutations after Tagrisso treatment. The mutation results in a cysteine to serine change in the 797 positions of the kinase domain sequence of the EGFR.

During pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations, while showing enhanced efficacy when combined with anti-EGFR antibodies.

With the ministry’s approval, the company plans to begin a dose-escalation study as the first part of phase 1 and 2 study in Korea to find the maximum tolerable dose (MTD) and the recommended phase 2 dose (RP2D) of the treatment, and observe the safety, tolerability and the anti-tumor efficacy of BBT-176 in advance NSCLC patients.

After completing the dose-escalation study, the company will conduct dose-expansion research in both Korea and the United States and assess the safety, tolerability, and efficacy along with the RP2D of the drug candidate.

Under the study protocol, the company will enroll about 90 patients in phase 1 and 2 study of BBT-176 and observe detailed anti-tumor efficacy in the combination therapy of BBT-176 with anti-EGFR antibodies.

“We are greatly encouraged by the IND clearance of BBT-176 in Korea,” Bridge Biotherapeutics CEO Lee Jung-kue said. “The company will continue to focus on bringing new treatment options for patients in need of a novel NSCLC therapy.”