Policy & Regulation
Bridge Biotherapeutics awarded FDA IND clearance for BBT-176, with first-in-human study later this year
20 January 2020 -

Biotech company Bridge Biotherapeutics Inc reported on Sunday the receipt of clearance from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for BBT-176 for advanced non-small cell lung cancer (NSCLC).

The South Korean company said BBT-176, a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI), is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in NSCLC.

Under the company's pre-clinical studies, BBT-176 exhibited strong anti-tumour efficacy in C797S triple mutations as well as displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

Additionally, the company will launch a dose escalation study under the first phase I/II study in Korea to find the maximum tolerated dose (MTD) and to observe safety, tolerability and anti-tumour efficacy of BBT-176 in the patient groups of advanced NSCLC.

In conjunction, will company will access the safety, tolerability and efficacy along with the best MTD of the drug candidate in the US and Korea in the second part of the dose expansion study.

Lung cancer is reportedly the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is split into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers.