BBT-176 is under development as a treatmentfor non-small cell lung cancer.
About the drug candidate
BBT-176 is under development as a targeted oral therapy for non-small cell lung cancer (NSCLC). BBT-176, a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI), exhibited strong anti-tumor efficacy in xenograft models harboring C797S triple mutations including Del19/T790M/C797S and L858R/T790M/C797S. Furthermore, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.
Bridge Biotherapeutics received IND clearance from both the US FDA and the South Korean MFDS and we plan to initiate a dose escalation study as the first part of the Phase I/II study in Korea to find the maximum tolerable dose (MTD), the recommended Phase II dose (RP2D) and to observe safety, tolerability and the anti-tumor efficacy of BBT-176 in a group of patients with advanced NSCLC. After completing the dose escalation study, a dose expansion study will be initiated in both the U.S. and South Korea. During this study, the company will assess the safety, tolerability and efficacy along with the RP2D of the drug candidate.
BBT-176 is expected to address the unmet medical needs of NSCLC patient groups with specific mutations which lead to fatal tumor growth. Candidates will be selected after conducting liquid biopsy tests to detect tumor-specific mutations and assigned to the clinical studies.
BBT-176 was discovered by the Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute, and was exclusively licensed out to Bridge Biotherapeutics in December 2018.
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What is NSCLC?
Lung cancer is the leading cause of cancer death, accounting for approximately one-fifth of all cancer deaths. There are two main types of lung cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), additionally NSCLC accounts for approximately 85% of all lung cancers. Across 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is said to be 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025. It is known that NSCLC stemming from EGFR mutations and/or overexpressions are more common within the Asian population. In addition, NSCLC can occur due to mutations and/or overexpressions by different proteins such as KRAS, ROS and ALK.