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Bridge Biotherapeutics' IND for EGFR Inhibitor Accepted by South Korean Regulators

NEW YORK – Clinical-stage biotech company Bridge Biotherapeutics said last week that its investigational new drug application for BBT-176 was accepted by South Korea's Ministry of Food and Drug Safety, allowing it to start clinical trials.

BBT-176 is a tyrosine kinase inhibitor designed to interrupt the EGFR signaling pathway perturbed by C797S mutations. Non-small cell lung cancer patients with EGFR C797S mutations tend to be resistant to the third-generation TKI osimertinib (AstraZeneca's Tagrisso).

BBT-176 was discovered by the Korea Research Institute of Chemical Technology. Bridge Biotherapeutics then acquired global exclusive rights for further development of the drug in December 2018.

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.

In January, the US Food and Drug Administration accepted Bridge Biotherapeutics' investigational new drug application for BBT-176, allowing the firm to start human trials in the US. 

In South Korea, Bridge Biotherapeutics plans to initiate the dose escalation portion of a Phase I/II study, which will enroll approximately 90 patients with advanced NSCLC, and establish the drug's maximum tolerated dose and the recommended Phase II dose. The company also plans to observe the safety, tolerability, and preliminary anti-tumor activity of BBT-176, both alone and in combination with anti-EGFR antibodies.