Bridge Biotherapeutics said it has filed an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety (MFDS).

The company plans to initiate phase 1 and 2 study of BBT-176, a clinical candidate for targeted lung cancer therapy.

BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), inhibits EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). BBT-176 exhibited strong antitumor efficacy in xenograft models harboring C797S triple mutations, including Del19/T790M/C797S and L858R/T790M/C797S. The treatment also displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

Since the EGFR C797S mutation was first reported three years ago, there have been no significant breakthroughs to target the clinically relevant mutant variant that impedes covalent bond formation with irreversible EGFR inhibitors.

The company plans to initiate dose-escalation studies in advanced NSCLC patients in Korea next year and to develop further clinical studies in both Korea and the U.S. afterward. In phase 1 and 2 study, the company will observe the safety, tolerability, and efficacy of the candidate in NSCLC patients.

"We are proud of the IND submission for BBT-176, which has shown a potential to be developed as a highly mutant-selective, fourth-generation EGFR-TKI for NSCLC treatment," Bridge Biotherapeutics CEO Lee Jung-kue said. "Our team will make our best effort to develop novel targeted lung cancer therapy inhibiting C797S EGFR mutation."

BBT-176 was discovered by the Korea Research Institute of Chemical Technology (KRICT), a government research institute. It was licensed to Bridge Biotherapeutics in December 2018 for the worldwide exclusive right for further development.