Bridge Biotherapeutics Inc., a clinical-stage biotech company headquartered in Seongnam, Republic of Korea, announced that the company has initiated the Phase 1/2 clinical trial assessing safety, tolerability, and anti-tumor activity of BBT-176 in non-small cell lung cancer (NSCLC) patients who acquired osimertinib-resistant EGFR triple mutations.

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 arises due to osimertinib (Tagrisso)-resistant mutations in NSCLC. The mutation results in a cysteine to serine change on amino acid 797 within the kinase domain sequence of the EGFR. From the pre-clinical studies, BBT-176 exhibited anti-tumor efficacy in mouse xenograft models and anti-brain metastases in patient-derived orthotopic xenograft models.

The Phase 1/2 study, an open-label study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBT-176 in patients with NSCLC who progressed following prior therapy with an EGFR TKI agent (NCT identifier: NCT04820023), is expected to enroll approximately 90 participants separated into two parts: a dose escalation phase (Part 1) and a dose expansion phase (Part 2). In the first part of the study, which has been initiated in the Republic of Korea, the RP2D (Recommended Phase 2 Dose) will be identified based on the evaluation of drug safety and tolerability in the treatment group. In the subsequent part of the study, which will be conducted both in the U.S. and Korea this year, primary and secondary outcome measures will include assessments of overall anti-tumor activity with objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. In addition, detailed mutation profiles collected through liquid and tumor biopsy procedures will be analyzed after the study.

"We are highly encouraged to be able to initiate the first-in-patient study of BBT-176, which is expected to address high unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," and "our Business Development team will be exploring strategic partnership opportunities as the clinical study progresses," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at ClinicalTrials.gov, using identifier NCT: 04820023.

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[1].

[1] GlobalData, Non-Small Cell Lung Cancer – Epidemiology Forecast Report to 2029, December 2020

About Bridge Biotherapeutics

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, the first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis currently in Phase II, 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 EGFR mutations.