On May 7, 2020 Bridge Biotherapeutics Inc.(KOSDAQ: 288330), a clinical stage biotech company headquartered in Seongnam, Republic of Korea, reported that the Investigational New Drug (IND) application of BBT-176 submitted to South Korea’s Ministry of Food and Drug Safety (MFDS) was officially cleared on May 7th (Press release, BridgeBio, MAY 7, 2020, View Source [SID1234557364]).

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BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). The mutation results in a cysteine to serine change in the 797 position of the kinase domain sequence of the EGFR. During pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. Additionally, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

On IND clearance in South Korea, Bridge Biotherapeutics plans 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 2 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.

Under the study protocol, approximately 90 patients are expected to be included in the Phase I/II study of BBT-176. The company will also observe detailed anti-tumor efficacy in the combination therapy of BBT-176 with anti-EGFR antibodies.

"We are greatly encouraged by the IND clearance of BBT-176 in South Korea," and "Bridge will continue to focus on bringing new treatment options for patients in need of a novel NSCLC therapy," said James Lee, CEO of Bridge Biotherapeutics.

BBT-176 was discovered by the Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute. The global exclusive rights for further development was licensed to Bridge Biotherapeutics in December 2018. Since the US FDA cleared the IND application of BBT-176 in January 2020, Bridge Biotherapeutics has been in continuous discussions with global and local pharmaceuticals and biotech companies regarding potential business alliance opportunities.

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