Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, announced that the Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) has been cleared on January 18th.

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 non-small cell lung cancer (NSCLC). In the pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. Furthermore, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

Bridge Biotherapeutics will initiate a dose escalation study as the first part of the phase I/II study in Korea to find the maximum tolerated dose (MTD) and to observe safety, tolerability and anti-tumor efficacy of BBT-176 in the patient groups of advanced NSCLC. In the second part of the study, which will be a dose expansion study, the safety, tolerability and efficacy along with the best MTD of the drug candidate will be assessed in the U.S. and Korea.

"We are highly proud of the IND clearance of BBT-176, a novel EGFR-TKI inhibiting C797S mutations for NSCLC treatments, by the U.S. FDA," and "Bridge will take the best-efficient development practices for bringing new treatment options for patients with NSCLC in need of novel therapy," said James Lee, CEO of Bridge Biotherapeutics.

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

Lung cancer is 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. Overall, across 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is assumed 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.ⁱ

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About Bridge Biotherapeutics

Bridge Biotherapeutics Inc., based in South Korea, US and China is a clinical stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high-unmet needs, such as ulcerative colitis, fibrotic diseases, and cancers. BBT-401, the first-in-class Pellino-1 inhibitor for treatment of ulcerative colitis, is currently in Phase II in the US, and BBT-877, an autotaxin inhibitor to treat various fibrosing interstitial lung diseases including idiopathic pulmonary fibrosis (IPF), was licensed to Boehringer-Ingelheim for further development in July 2019 with potential license value more than 1.1 billion euro. BBT-176, a potent targeted cancer therapy for non–small cell lung cancer (NSCLC) is also in development. Bridge Biotherapeutics is a resident company of JLABS @ Shanghai.

ⁱ Non-small cell lung cancer (NSCLC) - Global Drug Forecast and Market Analysis to 2025, GlobalData

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