Bridge Biotherapeutics Announces Initiation of Phase 1/2 Clinical Trial of BBT-207 in EGFR-Mutant NSCLC

SEONGNAM, South Korea and NEWTON, Mass., Oct. 31, 2023 /PRNewswire/ — Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for cancer, fibrosis, and inflammation, announced that the company has initiated the Phase 1/2 clinical trial evaluating the safety, tolerability, and antitumor activity of BBT-207 in non-small cell lung cancer (NSCLC) patients with EGFR mutations.

BBT-207, 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. Preclinically BBT-207 has shown activity against treatment-emergent complex EGFR mutations containing T790M and/or C797S as well as drug- naïve mutants providing a possibility to overcome resistance to prior TKIs.

The Phase 1/2 study (NCT05920135), an open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of BBT-207 in patients with NSCLC who have progressed following the use of at least one third-generation EGFR TKI, consists of three parts: dose escalation (Part 1), recommended phase 2 dose selection (Part 2), and dose expansion (Part 3). The study is expected to enroll approximately 92 patient participants who have advanced stage and refractory NSCLC with an activating EGFR mutation, documented partial response, complete response, or durable stable disease after the treatment of an EGFR TKI, and previous treatment with all standard therapeutic options and at least one third-generation EGFR TKI, including Osimertinib and Lazertinib.

The Phase 1a dose escalation cohort will determine the Recommended Dose Range (RDR), based on the totality of the data including toxicity/tolerability, efficacy, pharmacokinetic (PK), and pharmacodynamic (PD). During the Phase 1b RP2D selection stage, the safety monitoring committee will determine the Recommended Phase 2 Dose (RP2D) based on the totality of the data including overall safety, PK, PD, and preliminary antitumor activity including the percentage of patients with partial response (PR) or complete response (CR) based on RECIST Version 1.1. and duration of response (DOR). Finally, the Phase 2 dose expansion cohort will include assessments of preliminary anti-tumor activity utilizing the objective response rate (ORR) 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-207, which is expected to address unmet medical needs of advanced NSCLC patients with C797S mutations across the globe," said James Lee, CEO of Bridge Biotherapeutics.

Additional information about the clinical trial may be found at clinicaltrials.gov/study/NCT05920135.

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].

In September 2023, Bridge Biotherapeutics announced the discontinuation of the development of BBT-176, another fourth generation EGFR TKI at the Phase 1a stage, dose escalation part. The company will remain committed to the development of a fourth generation EGFR TKI, while seeking to concentrate its capacity and financial resources on BBT-207.

• STUDY TITLE: First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment with EGFR TKI
• STUDY DESIGN: An open-label, Phase 1/2 study evaluating safety, tolerability, PK, PD, and preliminary antitumor activity of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI. The study will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion phases
• TEST PRODUCT: Oral administration of BBT-207 throughout a 21-day cycle for each phase
• STUDY OBJECTIVES: To evaluate the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207 in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI

About Bridge Biotherapeutics, Inc.

Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S., 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 fibrotic diseases and cancers. The company is developing BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-207, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at https://www.bridgebiorx.com/en/.