• Pre-clinical data exploring the in vitro and in vivo efficacy of BBT-176 will be disclosed via an ePoster at the ESMO Congress 2021
• Patient dosing for the phase 1/2 clinical study of BBT-176 was initiated in April 2021…the topline data of the first-in-human, dose escalation study is expected to be announced in 2022

SEONGNAM, South Korea, Sept. 17, 2021 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company, announced that an ePoster presenting pre-clinical data of BBT-176,^[1] will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 (ePoster identifier:1365TiP).

At the virtual event, the pre-clinical data and the trial design of the ongoing phase 1/2 clinical study for BBT-176 in non-small cell lung cancer (NSCLC) patients will be presented via an ePoster.

BBT-176, which is currently in the dose escalation phase of the phase 1/2 study, was designed to inhibit the signaling pathway of epidermal growth factor receptors (EGFR) with C797S triple mutations acquired after progression on third-generation EGFR inhibitors such as osimertinib.

The in vitro data from engineered Ba/F3 cells and the in vivo data from patient-derived xenografts confirmed that BBT-176 is efficacious in NSCLC with C797S EGFR mutations.  As can be seen from the presented  in vitro assay, compared to osimertinib, BBT-176 is potent against EGFR double mutations such as Del19/C797S (DC) and L858R/C797S (LC) as well as triple mutations such as Del19/T790M/C797S (DTC) and L858R/T790M/C797S (LTC). Also, a dose-dependent anti-tumor effect has been confirmed in patient-derived cell (PDC)-xenograft mice models harboring Del19/T790M/C797S (DTC) triple mutations.

In addition, BBT-176 showed in vivo efficacy leading to brain metastases inhibition in triple-mutant mice models, using the IVIS® imaging platform. The brain metastases are found in approximately 20% of patients with stage IV NSCLC.

Encouraged by the non-clinical data demonstrating tumor regression efficacy in NSCLC with EGFR mutations, the first-in-human (FIH) study of BBT-176 was designed and patient dosing began in April 2021 under the IND of the U.S. and the Republic of Korea. Additional clinical trial sites in the U.S. to evaluate the efficacy and safety in diversified racial and ethnic groups particularly Caucasian patients are expected to open by the end of this year.      

Once the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) are determined, the company will initiate enrollment for the dose expansion cohort in the U.S. and the Republic of Korea. In parallel with the clinical development of BBT-176, the company will also continue to expand its NSCLC solutions, utilizing precision medicine accompanied by companion diagnostic devices.

"We are proud to present the exploratory efficacy data from our pre-clinical studies for BBT-176, our first-ever oncology pipeline, to both European and international oncologists," and "by accelerating our development of 4^th generation EGFR TKIs, we will try our best to address the unmet medical needs of patients with NSCLC," stated Dr. Sang Yoon Lee, Chief Medical Officer of Bridge biotherapeutics.

The copy of the ePoster presented at the ESMO 2021 is available at: https://bit.ly/2YLgsw4.

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 such as 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 Non-small Cell Lung Cancer:

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. Lung cancer is classified into two main groups: non-small cell lung cancers (NSCLC) and small cell lung cancers (SCLC), where NSCLC accounts for approximately 85% of all lung cancer diagnoses. In 2019, there were a combined 0.79 million diagnosed cases of NSCLC in men and women, aged 18 years and older, across the US, France, Germany, Italy, Spain, the UK, Japan, and urban China. The incidence of NSCLC is expected to increase at an annual growth rate (AGR) of 3.01% from 2019 to 2029, reaching 1.03 million cases in 2029^[2].