On April 23, 2023 Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea and Cambridge that is advancing novel drugs for cancer, fibrosis, and inflammation, reported that it received notice from the U.S. Food and Drug Administration (FDA) that it may proceed with the first-in-human study of BBT-207, which has the potential to be a mutant selective and broad-spectrum fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) for the treatment of non-small cell lung cancer (NSCLC) (Press release, Bridge Biotherapeutics, APR 23, 2023, View Source [SID1234630398]). (US IND Number: IND 165492)

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The company recently disclosed up-to-date preclinical data for BBT-207 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 annual meeting. According to the poster presentation, the company highlighted the intracranial antitumor activity as well as the antitumor efficacy of the experimental drug through in vitro and in vivo studies. Overall, the company explored potent activity and efficacy against a broad range of EGFR mutations in NSCLC, including C797S double mutations, which arise after third-generation EGFR TKI treatment.

"We’re excited to initiate the clinical development of BBT-207 in order to address the unmet medical needs of NSCLC patients," said James Lee, founder and CEO of Bridge Biotherapeutics. "With this approval, the company will continue to focus on developing novel treatment options for late-stage lung cancer patients suffering from third-generation EGFR TKI resistance."

The first-in-human study of BBT-207 consists of three phases. Bridge plans to initiate a dose escalation study during phase 1a to determine the Recommended Dose Range (RDR) based on the toxicity/tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of the experimental drug. Also, phase 1a aims to observe safety and tolerability of BBT-207 based on treatment-emergent adverse events (AEs), etc. Through phase 1b, the company will select the recommended phase 2 dose (RP2D) based on PK, PD, objective response rate (ORR), duration of response (DOR), and the overall safety profile. Finally, during the dose expansion study, phase 2 preliminary antitumor activity of BBT-207 will be evaluated based on RECIST Version 1.1.

The multi-centered study is expected to include approximately 15 clinical sites in the United States and South Korea, targeting up to 92 patient participants.

STUDY TITLE: First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment with EGFR TKI
STUDY DESIGN: An open-label, Phase 1/2 study evaluating safety, tolerability, PK, PD, and preliminary antitumor activity of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI. The study will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion phases
TEST PRODUCT: Oral administration of BBT-207 throughout a 21-day cycle for each phase
STUDY OBJECTIVES: To evaluate the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI