BridgeBio Initiates Patient Dosing in Phase 1/2 Trial of 4th Generation Lung Cancer Drug Candidate

4th Generation Lung Cancer Targeted Therapy Candidate 'BBT-207'

Bridge Biotherapeutics announced on the 31st that it has initiated the first patient dosing of the Phase 1/2 clinical trial at Samsung Medical Center to evaluate the antitumor efficacy and safety of its 4th-generation lung cancer targeted therapy candidate, 'BBT-207,' in patients.

Bridge Biotherapeutics CI. [Image provided by Bridge Biotherapeutics]

BBT-207 is being developed as a 4th-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that selectively inhibits a wide spectrum of mutations found in non-small cell lung cancer (NSCLC) patients. Resistance to 3rd-generation EGFR inhibitors in NSCLC patients often results in the emergence of double mutations positive for C797S, among others.

Bridge Biotherapeutics recently independently discovered BBT-207 through its corporate research institute to rapidly respond to the evolving lung cancer treatment trends, such as the expansion of 3rd-generation EGFR inhibitors like Tagrisso and Rybrevant as first-line therapies.

According to Bridge Biotherapeutics, preclinical studies showed that BBT-207 demonstrated competitive antitumor efficacy against double mutations including C797S and triple mutations that may arise after first-line treatment with 3rd-generation EGFR inhibitors in NSCLC. Additionally, it exhibited significant brain metastasis suppression, which is crucial in treating advanced NSCLC.

This clinical trial will be the first to explore the efficacy and safety of the drug in 92 NSCLC patients from the United States and Korea whose disease progressed after treatment with one or more 3rd-generation EGFR inhibitors. The trial will also apply liquid biopsy procedures to rapidly analyze tumor mutation information from circulating tumor DNA in blood, allowing detailed assessment of patient groups by mutation type.

The Phase 1/2 clinical trial of BBT-207 will proceed in three stages. First, a dose-escalation study corresponding to Phase 1a will determine the recommended dose range (RDR) based on the drug’s efficacy and safety. Next, Phase 1b will establish the recommended Phase 2 dose (RP2D), followed by a dose-expansion study in Phase 2, where the drug’s antitumor activity will be explored by measuring objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, said, "As global demand for next-generation therapies in the treatment of NSCLC continues to rise, we are honored that BBT-207, the first drug independently discovered by Bridge Biotherapeutics, has swiftly entered clinical trials in patients. Leveraging our accumulated clinical experience with 4th-generation EGFR inhibitors, we will conduct the trials more efficiently and strive to provide new treatment options as soon as possible to patients with advanced resistant lung cancer."

Meanwhile, Bridge Biotherapeutics officially announced the discontinuation of development for 'BBT-176,' which was previously developed targeting C797S-positive triple mutations, following the completion of its Phase 1a clinical trial. The company plans to focus its research and development capabilities on accelerating the development of BBT-207, which is expected to have greater market potential.

This content was produced with the assistance of AI translation services.