BridgeBio Lung Cancer Treatment, US Phase 1 and 2 Clinical Trial Plans Approved

4th Generation EGFR Mutant Non-Small Cell Lung Cancer Treatment
'BBT-207' FDA IND Approval
Expanding Lung Cancer Pipeline with 'BBT-176'

Bridge Biotherapeutics announced on the 24th that its 'BBT-207,' a 4th-generation epidermal growth factor receptor (EGFR) mutation-targeted therapy for non-small cell lung cancer (NSCLC), has received final approval for its Phase 1/2 clinical trial plan (IND) from the U.S. Food and Drug Administration (FDA).

Bridge Biotherapeutics logo
[Photo by Bridge Biotherapeutics]

BBT-207 is a 4th-generation EGFR tyrosine kinase inhibitor (EGFR TKI) that selectively inhibits a wide spectrum of mutations, including the C797S-positive double mutation that arises as resistance after treatment with 3rd-generation EGFR inhibitors in NSCLC patients. To respond more swiftly to the diversifying treatment trends of NSCLC, Bridge Biotherapeutics independently discovered BBT-207 as its first candidate compound. It is expected to further strengthen the company’s next-generation lung cancer treatment pipeline as a separate project from BBT-176, which is being developed targeting the existing C797S-positive triple mutations.

At the recent American Association for Cancer Research (AACR) 2023 Annual Meeting, Bridge Biotherapeutics presented preclinical data of BBT-207 in poster form, explaining that they explored the antitumor efficacy of BBT-207 against a broad range of EGFR mutations in NSCLC, including the C797S double mutation that occurs after 3rd-generation EGFR inhibitor treatment, through in vivo and in vitro studies. Additionally, analysis of data from experiments using patient-derived lung cancer cell-based animal models visualizing metastatic status showed that the BBT-207 treatment group exhibited a reduced level of metastasis compared to the control group, confirming the drug’s brain metastasis suppression effect and improved survival outcomes.

Bridge Biotherapeutics plans to enter the preparation stage for initiating Phase 1/2 clinical trials of BBT-207 following this IND approval. The clinical trial will be conducted at approximately 15 clinical institutions in the U.S. and Korea, enrolling up to 92 NSCLC patients to evaluate the drug’s safety, tolerability, and antitumor efficacy.

The clinical trial will proceed in three stages. First, a dose-escalation study corresponding to Phase 1a will determine the recommended dose range based on toxicity, tolerability, efficacy, pharmacokinetics, and pharmacodynamics profiles, while clarifying safety and tolerability.

Subsequently, Phase 1b will establish the recommended dose for Phase 2, leading to a dose-expansion study in Phase 2. During the dose-expansion phase, the drug’s preliminary antitumor activity will be assessed by measuring the objective response rate (ORR) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Lee Jung-kyu, CEO of Bridge Biotherapeutics, stated, “As the first company among 4th-generation lung cancer targeted therapy developers to enter the FDA-approved clinical stage, we are honored to add BBT-207 to our clinical-stage lung cancer pipeline. We will make BBT-207 and BBT-176 the major pillars of our lung cancer pipeline, accelerating new drug development while focusing on negotiations to optimize the value of these drugs and achieve successful business development outcomes.”