Bridge Biotherapeutics to Announce Updated Data from its Phase 1 Study of BBT-176 in Advanced Non-Small Cell Lung Cancer in an Oral Presentation at IASLC 2022 World Conference on Lung Cancer

Data analysis to explore demonstrated anti-tumor activity of BBT-176,a fourth generation EGFR TKI,in advanced non-small cell lung cancer

SEONGNAM,South Korea,May 10 -- Bridge Biotherapeutics Inc. (KQ288330),a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer,fibrosis and inflammation,announced it will deliver an oral presentation highlighting the analysis data from the first-in-patient study of BBT-176[1] at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC 2022 WCLC).

At its latest presentation to investors,Bridge Biotherapeutics shared interim Phase 1 study data of BBT-176 in advanced non-small cell lung cancer (NSCLC) showing that the drug candidate was well-tolerated and demonstrated efficacy against EGFR-mutation positive NSCLC,including C797S containing EGFR triple mutations. According to the company's presentation,BBT-176 has shown anti-tumor efficacy with two partial response cases,one in the 160 mg QD cohort (51 percent tumor shrinkage) and the other in the 320 mg QD cohort (30 percent tumor shrinkage).

Pharmacokinetics data show that BBT-176 exhibits dose-dependent exposure. In addition,safety data have shown that adverse events (AEs) typically associated with EGFR inhibitors have been found but were limited to Grade 1-3 adverse events. The Phase 1 dose escalation study will be continued through an exploratory cohort to determine the maximum tolerable dose (MTD) and recommended Phase 2 dose (RP2D).

Sang-Yoon Lee,M.D.,Bridge Biotherapeutics' chief medical officer,said,"We are encouraged by these interim results from our Phase 1 trial of BBT-176,a fourth-generation EGFR TKI. In addition to continuing the trial,Bridge Biotherapeutics is promoting innovation by exploring the potential clinical value of liquid biopsies for both diagnosis and evaluation of therapeutic responses in NSCLC. We believe this will be another innovative aspect of our clinical development of BBT-176. Bridge Biotherapeutics remains focused on delivering novel treatment options to address the high unmet medical needs of advanced NSCLC patients."

The company's oral presentation on BBT-176 is expected to be held on August 8,during IASLC 2022 WCLC,in Vienna,Austria.

About Bridge Biotherapeutics

Bridge Biotherapeutics Inc. is a publicly traded clinical-stage biotech company based in the Republic of Korea with offices in the U.S. and China. Founded in 2015,Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics for disease indications with high unmet medical needs including cancer,ulcerative colitis,and fibrotic diseases. The company's clinical pipeline includes 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. For more information,visit https://www.bridgebiorx.com/en/.

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 aims to assess 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 maximum tolerable dose (MTD) and 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.

[1] A Phase 1/2,Open-Label Study to Assess the Safety,Tolerability,Pharmacokinetics,and Anti-tumor Activity of BBT-176 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) Agent (https://clinicaltrials.gov/ct2/show/NCT04820023)

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