Bridge Biotherapeutics advances phase 1 study of BBT-207 in NSCLC

Bridge Biotherapeutics, a Korean biotech firm, said on Tuesday that it has completed reviewing dosing data from the third dose group of its phase 1 clinical trial for BBT-207, a new drug candidate for non-small cell lung cancer (NSCLC), and has advanced to the fourth dose group based on the recommendation of an expert committee.

The phase 1 dose-escalation study of BBT-207, which is being developed as a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), aims to confirm the drug's safety and efficacy by gradually increasing the dose in patients. 

The fourth dose group of the trial falls within the medium-to-high dose range, where the company expects to verify the drug's efficacy. Bridge Biotherapeutics said the trial is designed to be flexible, allowing more patients to be enrolled in dose groups where repeated signals of efficacy are observed, potentially accelerating development.

BBT-207 was independently discovered by the company in 2021 to address evolving trends in lung cancer treatment. In nonclinical studies, BBT-207 has shown competitive antitumor activity against double and triple mutations, including C797S, which can develop after first-line treatment with third-generation EGFR inhibitors in NSCLC, as well as inhibition of brain metastasis, which is crucial for treating late-stage NSCLC.

"Thanks to close collaboration with researchers, patients, and clinical trial sites, we are pleased to have reached the dose range where BBT-207 is expected to confirm its efficacy," said Lee Jung-kue, CEO of Bridge Biotherapeutics. "We will continue to lead in the development of fourth-generation EGFR inhibitors both domestically and globally, ensuring smooth progress by continually demonstrating our competitiveness."