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Bridge to join as an industry member to advance the science of early detection and speed development of novel treatments SEONGNAM, South Korea and CAMBRIDGE, Mass., July 11, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for fibrosis, cancer and inflammation, announced that it has joined PROLIFIC, the Prognostic Lung Fibrosis Consortium, an organization devoted to boosting scientific exploration and drug development in pulmonary fibrosis. PROLIFIC is a non-profit consortium of top-tier research institutions, academic medical centers, and pharmaceutical and biotech companies that are committed to developing treatments for pulmonary fibrosis. Members of PROLIFIC collaborate with each other to share expertise, technology, and data to develop precise and personalized treatments for patients with the fatal and progressive lung diseases. The near-term goal of PROLIFIC is to develop and validate tests for biomarkers indicative of pulmonary fibrosis in patients and to assess the biomarkers in predicting disease worsening or as suitable endpoints for clinical trials. "We are excited to join PROLIFIC and collaborate with other leaders in precision medicine to advance the understanding of pulmonary fibrosis and advance the science of biomarkers to detect this devastating disease," said Sujin Jung, Vice President of Clinical Development and Operations of Bridge Biotherapeutics. "As a member of PROLIFIC, we will be able to tap into a diverse range of expertise, technology, and data that will enable us to accelerate detection of pulmonary fibrosis, and speed the entire industry's development of new treatments." The group of industry members at PROLIFIC has selected 12 biomarkers based on peer-reviewed scientific reports showing their ability to predict the presence of the disease itself, and their potential ability to predict how well a drug candidate may work. The 12 biomarkers being studied include indicators of epithelial damage (CYFRA 21-1, SP-D, CA-19-9, KL-6), fibrosis (MMP-7, Tenascin C, periostin), inflammation (CCL18, CXCL13, slCAM1), and thrombosis (PAI-1). Having a validated panel of biomarkers could enable early detection of treatment response and comparison of drugs across clinical trials, which could speed regulatory approval. PROLIFIC also intends to partner with public health authorities worldwide to achieve the long-term goal of finding biomarkers that can predict which patients would benefit most from a particular treatment, bringing a precision medicine approach to the treatment of this chronic, often fatal condition. The consortium hopes to enable physicians to better tailor therapeutic treatments for patients. By joining PROLIFIC, Bridge Biotherapeutics will be able to collaborate with other pioneering companies in the area of pulmonary fibrosis. In addition to industry-wide advances, Bridge Biotherapeutics hopes to speed development of proprietary idiopathic pulmonary fibrosis pipeline and accelerate development of novel treatments for patients. Bridge Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for areas of high unmet medical needs. The company has three drugs in clinical trials for the treatment of fibrotic diseases such as idiopathic pulmonary fibrosis, as well as inflammatory diseases and cancers, and a robust pipeline of drug candidates in preclinical development. About PROLIFIC PROLIFIC, founded in 2020 by the Pulmonary Fibrosis Foundation and Bristol Myers Squibb, is a consortium of top-tier research institutions, academic medical centers, and biopharmaceutical companies that are committed to advancing precision medicine. The consortium aims to develop well-qualified assays to detect important peripheral blood protein biomarkers in patients with pulmonary fibrosis. Members of PROLIFIC collaborate to share expertise, technology, and data to develop more precise and personalized treatments for patients with devastating and progressive lung diseases. Industry members of PROLIFIC include BMS, Chiesi, Galapagos, Galecto, Genentech, Gilead, Lassen Therapeutics, Lung Therapeutics, NeRRe Therapeutics, Novartis, OptiKira, Pliant Therapeutics, Pulmonary Fibrosis Foundation, Three Lakes Foundation, Tvardi Therapeutics. 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 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), BBT-176 and BBT-207, potent targeted cancer therapies for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at . SOURCE Bridge Biotherapeutics, Inc.

SEONGNAM, South Korea and CAMBRIDGE, Mass., May 29, 2023 /PRNewswire/ -- Bridge Biotherapeutics Inc. (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, is scheduled to give a company presentation on Tuesday, June 6 at the 2023 BIO International Convention taking place in Boston, Massachusetts, between June 5 - 8, 2023. Pavel Printsev, Director of Business Development, will provide an up-to-date company overview as well as an introduction to its clinical-stage assets: Oncology: BBT-176 and BBT-207 (Fourth-generation EGFR TKIs for non-small cell lung cancer active against C797S resistance mutations) Pulmonology: BBT-877 (Autotaxin inhibitor for idiopathic pulmonary fibrosis) Earlier this year, the company announced its acquisition of a diagnostics company with a novel biosensing technology. The company presentation is expected to include an introduction to the newly acquired biosensing technology and commercial prospects. "We are pleased to share the progress of clinical assets as well as new business activities through an in-person presentation at this year's BIO International conference, following last year's event. We look forward to advancing our novel research and development pipeline with a strong focus on oncology and pulmonology," stated Pavel Printsev, Director of Business Development of Bridge Biotherapeutics. To learn more about this session, please visit the events page on our website at . Date & Time: Tuesday, June 6th, 2023, 3:15 PM (ET) Place: Room 104B Therapeutic category: Multiple Therapeutics About Bridge Biotherapeutics 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 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), BBT-176 and BBT-207, potent targeted cancer therapies for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at . SOURCE Bridge Biotherapeutics, Inc.

The company has been notified by the FDA that the Phase 1/2 clinical trial may proceed The latest preclinical data explored the antitumor efficacy and the intracranial activity of BBT-207 SEONGNAM, South Korea and CAMBRIDGE, Mass., April 23, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea and Cambridge that is advancing novel drugs for cancer, fibrosis, and inflammation, announced that it received notice from the U.S. Food and Drug Administration (FDA) that it may proceed with the first-in-human study of BBT-207, which has the potential to be a mutant selective and broad-spectrum fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) for the treatment of non-small cell lung cancer (NSCLC). (US IND Number: IND 165492) The company recently disclosed up-to-date preclinical data for BBT-207 at the American Association for Cancer Research (AACR) 2023 annual meeting. According to the poster presentation, the company highlighted the intracranial antitumor activity as well as the antitumor efficacy of the experimental drug through in vitro and in vivo studies. Overall, the company explored potent activity and efficacy against a broad range of EGFR mutations in NSCLC, including C797S double mutations, which arise after third-generation EGFR TKI treatment. "We're excited to initiate the clinical development of BBT-207 in order to address the unmet medical needs of NSCLC patients," said James Lee, founder and CEO of Bridge Biotherapeutics. "With this approval, the company will continue to focus on developing novel treatment options for late-stage lung cancer patients suffering from third-generation EGFR TKI resistance." The first-in-human study of BBT-207 consists of three phases. Bridge plans to initiate a dose escalation study during phase 1a to determine the Recommended Dose Range (RDR) based on the toxicity/tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of the experimental drug. Also, phase 1a aims to observe safety and tolerability of BBT-207 based on treatment-emergent adverse events (AEs), etc. Through phase 1b, the company will select the recommended phase 2 dose (RP2D) based on PK, PD, objective response rate (ORR), duration of response (DOR), and the overall safety profile. Finally, during the dose expansion study, phase 2 preliminary antitumor activity of BBT-207 will be evaluated based on RECIST Version 1.1. The multi-centered study is expected to include approximately 15 clinical sites in the United States and South Korea, targeting up to 92 patient participants. 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 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. Learn more at . About BBT-207 BBT-207, a novel fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) is the company's first internally discovered drug candidate with potent activity and efficacy against a broad range of EGFR mutations in non-small cell lung cancer (NSCLC), including C797S mutations which arise after third-generation EGFR TKI treatment. An investigational new drug application for the first-in-human study in patients with advanced NSCLC harboring EGFR mutation after treatment with EGFR TKI was cleared in April 2023. SOURCE Bridge Biotherapeutics, Inc.