Bridge Biotherapeutics to Present Interim Clinical Data from Ongoing Phase 1 Study of BBT-176 at the World Conference of Lung Cancer

The abstract suggests that BBT-176 has shown its capability of inducing clinical tumor responses in EGFR triple mutation-containing patients

Further exploration of the drug efficacy and safety profiles at RP2D is planned

The abstract is now available on the IASLC 2022 WCLC website

SEONGNAM,South Korea,July 13,2022 -- Bridge Biotherapeutics (KQ288330),a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer,fibrosis and inflammation,announced that interim clinical data from an ongoing Phase I study of BBT-176 has been selected for a mini oral presentation at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer(IASLC WCLC 2022),Aug. 6-9 in Vienna.

The oral presentation,to be delivered by Sun Min Lim,M.D.,Ph.D.,assistant professor at Yonsei University College of Medicine,will discuss interim clinical data from the Phase I study of BBT-176 in advanced non-small cell lung cancer (NSCLC) patients harboring an EGFR mutation who were previously treated with at least one epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). According to the published abstract,the presentation will cover potent anti-tumor efficacy of BBT-176 explored with radiological improvements in both target and non-target lesions from two patients harboring EGFR triple mutations of exon 19 del/T790M/C797S.

One patient from the 320mg dosing cohort exhibited 30.3 percent shrinkage of the target lesion,according to the abstract. Another patient from the 480mg dosing cohort exhibited 26.3 percent shrinkage of the target lesion. Investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety,efficacy and tolerability information collected in the Phase 1 clinical study.

The abstract for the presentation (MA07.09) is now available at https://bit.ly/3uv2StQ.

Session and Presentation Information

Title:BBT-176,a 4th-generation EGFR TKI,for Progressed NSCLC after EGFR TKI Therapy: PK,Safety and Efficacy from Phase 1 Study

Session Title: Overcoming Resistance to EGFR Inhibitors

Session Number:MA07.09

PresentationSession:August 8,2022,12:52 pm CET

Presenting Author:Sun Min Lim,Yonsei University College of Medicine

Session Discussant: Pasi A. Jänne,Dana-Farber Cancer Institute

About Bridge Biotherapeutics,Inc.

Bridge Biotherapeutics Inc.,based in the Republic of Korea,US,andChina,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. InApril 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. 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.

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