BridgeBio's Lung Cancer Treatment Phase 1 Clinical Trial Progresses Smoothly

Bridge Biotherapeutics announced on the 25th that it has completed the review of patient dosing data for the fourth dose cohort in the Phase 1 clinical trial of BBT-207, being developed as a treatment for non-small cell lung cancer, and has entered the fifth dose cohort based on unanimous agreement from the investigators.

Bridge Biotherapeutics logo
[Photo by Bridge Biotherapeutics]

Since October last year, Bridge Biotherapeutics has been conducting a Phase 1 dose-escalation trial of BBT-207, a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The company is gradually increasing the dosing levels in clinical subjects to verify the drug’s safety and efficacy.

At the recently held Safety Monitoring Committee (SMC), the safety and efficacy data related to patient dosing in the fourth dose cohort of the BBT-207 Phase 1 trial were reviewed. As the company entered the key dose cohort expected to confirm the drug’s efficacy, efficacy was evaluated in five dosed patients using liquid biopsy and radiological methods. As a result, no dose-limiting toxicities (DLTs) restricting escalation to the next dose were reported, and efficacy signals were observed in some patients, leading to immediate entry into the fifth dose cohort and the start of patient recruitment.

The company independently discovered BBT-207 in 2021 to rapidly respond to the evolving trends in lung cancer treatment. In preclinical studies, it demonstrated competitive antitumor efficacy and brain metastasis suppression against additional mutations that may occur after first-line treatment with third-generation EGFR inhibitors in non-small cell lung cancer.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, stated, “Having entered the key dose cohort in Phase 1 without safety concerns, we will continue the clinical trial as planned. We will maintain our leadership in the development of fourth-generation EGFR inhibitors in both domestic and global markets, continuously confirming our competitiveness and dedicating ourselves to ensuring smooth progress in development.”