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FDA Accepts Bridge Biotherapeutics' Investigational New Drug Application for Lung Cancer Drug

NEW YORK – Seongham, South Korea-based biotech company Bridge Biotherapeutics said the US Food and Drug Administration has accepted its investigational new drug application for BBT-176, allowing the firm to start studying the drug in non-small cell lung cancer patients who have become resistant to osimertinib (AstraZeneca's Tegrisso) due to EGFR C787S mutations.

BBT-176 is designed to tackle EGFR C797S resistance mutations that arise in NSCLC patients after treatment with third-generation tyrosine kinase inhibitors (TKIs) like osimertinib. In pre-clinical studies, BBT-176 has shown strong antitumor efficacy in xenograft models with C797S triple mutations: Del19/T790M/C797S and L858R/T790M/C797S. Its efficacy was enhanced when it was administered in combination with anti-EGFR antibodies.

Bridge aims to start first-in-human studies in the US and Korea for NSCLC patients this year. Its Phase I/II trial will consist of a dose escalation study to find the maximum tolerated dose followed by an expansion study that will assess safety, tolerability, and efficacy of the drug.