Bridge Biotherapeutics Presents Promising Interim Clinical Study Results from Phase 1 Study of BBT-176 at WCLC 2022

• The study confirmed preliminary efficacy and safety of BBT-176 along with its treatment responses in advanced NSCLC patients
• A patient with the C797S triple mutation showed up to 53 percent reduction in EGFR mutant allelic change

VIENNA and SEONGNAM, South Korea, Aug. 10, 2022 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, announced promising interim clinical data from its Phase I study of BBT-176, a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The data, presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), show promising early evidence of efficacy and favorable tolerability in patients with non-small cell lung cancer (NSCLC).

The oral presentation delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, discussed the correlation between molecular response and radiologic response in patient participants in the study. One patient with advanced NSCLC showing C797S triple mutations, confirmed as one of the partial response (PR) cases, showed up to 53 percent decrease of EGFR mutant allele frequency compared to the baseline. Data from the five patients who had been treated with BBT-176 over 100 days suggested that circulating tumor DNA (ctDNA) analysis enabled with liquid biopsy may be useful not only in identifying those most likely to benefit from fourth-generation EGFR TKI treatments such BBT-176, but also monitoring therapeutic response with treatment of a fourth-generation EGFR TKI.

The study also confirmed the preliminary efficacy of BBT-176 in treating advanced NSCLC patients harboring an EGFR mutation who had previously been treated with at least one EGFR TKI. Adverse events were primarily low grade, with GI toxicities and skin rash being most common, necessitating dose modifications in some patients. The pharmacokinetic profile of BBT-176 was shown to be dose-proportional in the study.

As the study continues, investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected. Upon determination of the RP2D, investigators are expected to initiate the Phase 2 study next year.

Session and Presentation Information
Title:  BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Preliminary Efficacy from Phase 1 Study
Session Title:  Overcoming Resistance to EGFR Inhibitors
Session Number:  MA07.09
Presentation Session:  August 8, 2022, 12:52 pm CET
Presenting Author:  Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea, US, and China, is a publicly-traded, 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 including ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-176, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with C797S triple EGFR mutations.

About BBT-176

BBT-176 is under development as a novel, fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that inhibits the signaling pathway of EGFR with C797S containing triple mutations. In April 2021, the company initiated the dose escalation part of its Phase I/II trial, which is being conducted in three sites in the Republic of Korea. The study has been assessing the safety, tolerability, and anti-tumor efficacy of the drug candidate in a group of patients with advanced non-small cell lung cancer. After determining the recommended Phase 2 dose (RP2D), the dose expansion study will be initiated in both the U.S. and the Republic of Korea. It is estimated about 10,000 to 20,000 new NSCLC patients will be diagnosed each year with EGFR triple mutations by the mid-2030s. BBT-176 is currently the first-in-class, fourth-generation EGFR TKI candidate targeting C797S triple mutation variants. Bridge Biotherapeutics acquired the exclusive global license for BBT-176 from the Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute, in 2018. The Phase I clinical study of BBT-176 was partially supported by the Korea Drug Development Fund (HN21C0859), which is funded by Ministry of Science and ICT, Ministry of Trade, Industry and Energy, and Ministry of Health and Welfare, of Republic of Korea.