BBT-207 / Bridge Biotherap - LARVOL DELTA

Bridge Biotherapeutics …announced on the 19th that it voluntarily withdrew its Phase 1/2 clinical trial for its EGFR-TKI anticancer drug candidate, BBT-207, from the Korean Ministry of Food and Drug Safety (MFDS) and the U.S. Food and Drug Administration (FDA). [Google translation] (Nate) - "The company explained that this decision was 'to shift our strategy away from our in-house R&D-centered strategy to focusing on discovering partners and licensing out, leveraging the acquired results'."

Trial termination • Non Small Cell Lung Cancer

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem) - "This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=92 ➔ 24

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics Raises Expectations for Confirmation of Effective Dose of BBT-207 in Lung Cancer Clinical Trial [Google translation] (BioTimes) - "Bridge Biotherapeutics...recently held its 5th Safety Monitoring Committee (SMC) meeting and announced that it has completed the review of patient dosing data for the fifth dose group of the phase 1 clinical trial of BBT-207, a non-small cell lung cancer treatment candidate....At the recent SMC meeting, data obtained from six patients enrolled in the fifth dose group of the BBT-207 Phase 1 clinical trial were analyzed to evaluate the drug’s efficacy and safety. As a result of the review, there were no significant adverse drug reactions related to the drug, and it was decided to increase the number of patients administered the dose at which repeated efficacy signals were confirmed, including three cumulative partial responses (PR)1 and multiple stable disease (SD) cases, to secure additional data. The company plans to begin phase 1b clinical trials in the second half of the year after selecting two final recommended doses from the dose-escalation trial in phase 1a clinical trials."

DSMB • Trial status • Non Small Cell Lung Cancer

Bridge Biotherapeutics and HitGen Initiate Research Collaboration to Advance Novel Cancer Therapeutics Program (PRNewswire) - "Bridge Biotherapeutics...announced that it has entered into a joint research agreement with HitGen Inc...This collaboration builds on successful initial hit finding and identification work from HitGen's DNA-encoded library (DEL), aiming to further develop the novel hits as promising drug candidates for cancer...Bridge plans to strengthen its existing oncology portfolio, which is centered on EGFR inhibitors for lung cancer treatment, through new anticancer drug candidates targeting undisclosed targets...With the launch of this joint research with HitGen, it is anticipated that the derivation of effective substances, optimization, and securing of lead compounds will progress rapidly within the next year."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics advances phase 1 study of BBT-207 in NSCLC (Korea Biomedical Review) - "Bridge Biotherapeutics, a Korean biotech firm, said on Tuesday that it has completed reviewing dosing data from the third dose group of its phase 1 clinical trial for BBT-207, a new drug candidate for non-small cell lung cancer (NSCLC), and has advanced to the fourth dose group based on the recommendation of an expert committee....The fourth dose group of the trial falls within the medium-to-high dose range, where the company expects to verify the drug's efficacy."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Bio goes smoothly with paid-in capital increase process… First issuance price confirmed on the 11th of next month [Google translation] (News1 Korea) - "Bridge Biotherapeutics' paid-in capital increase process is progressing smoothly. The funds secured through capital increase are expected to be used for clinical trials of 'BBT-877'...for idiopathic pulmonary fibrosis. RigaChem Bioscience...is actively considering participating in this paid-in capital increase...Bridge Biotherapeutics announced that it plans to confirm the first issuance price for paid-in capital increase on the 11th of next month. The plan is to set the 14th of the same month as the base date for allotment of new shares through paid-in capital increase...In addition, as the clinical trials of BBT-877 and 'BBT-207', which are making all efforts as key tasks, are progressing smoothly, a capital increase was decided to preemptively secure additional costs...In relation to BBT-877 Phase 2, a total of three IDMC meetings were held....Bridge Bio plans to hold the next meeting in September 2024 to continuously monitor the safety of clinical participants."

Financing • Trial status • Idiopathic Pulmonary Fibrosis • Lung Cancer • Oncology • Solid Tumor

Bridge Bio selected as ‘presenting company’ at 2024 Bio USA for 3 consecutive years [Google translation] (Medipana) - "We plan to share major progress and additional data related to clinical trials. In particular, as the registration of patients in the multinational phase 2 clinical trial of BBT-877 progresses to approximately 75% of the target, discussions on the drug's efficacy and safety are expected to progress further....the company has been selected as a Bio USA presenting company for the third consecutive year and will conduct a company introduction presentation to industry officials and potential partners. In an oral presentation held at 2 pm on the 3rd (local time)...Pavel Printsev will discuss the current status of development of major clinical projects BBT-877 and BBT-207 (non-small cell lung cancer treatment candidates), as well as future expectations. Share key development milestones. In addition, we are preparing a U.S. clinical trial plan (IND) for BBT-301 (a candidate for the treatment of idiopathic pulmonary fibrosis)..."

Clinical • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Bio promotes paid-in capital increase to shareholders worth 26.2 billion won... “Clinical Acceleration” [Google translation] (Nate) - "Bridge Biotherapeutics...is developing 'BBT-877', a new drug candidate for idiopathic pulmonary fibrosis, and 'BBT-207', a next-generation lung cancer drug candidate, being developed through a paid-in capital increase worth 26.2 billion won. Speed ​​up development...A Bridge Bio official said, 'As the clinical trials of BBT-877 and BBT-207, the two leading tasks, are progressing smoothly, we will preemptively secure the expected costs and further increase the speed of progress so that the time it takes for the product to reach the market.'...'Through this financing, we plan to successfully complete the Phase 2 clinical trial to confirm BBT-877 as a global innovative new drug,'...'We plan to actively pursue technology transfer during Phase 2.'"

Financing • Idiopathic Pulmonary Fibrosis • Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor

Bridge Bio 'Exploring global business development and new cooperation at 2024 JPMHC' [Google translation] (HIT News) - "Bridge Biotherapeutics (CEO Jeong-gyu Lee) is holding a business development (BD) event including CEO Jeong-gyu Lee in line with the '2024 JP Morgan Healthcare Conference (JPMHC)' held in San Francisco, USA from the 8th (local time) to the 11th. It was announced on the 3rd that a business trip team consisting of professional executives would be dispatched to the site....The company plans to meet with global pharmaceutical and bio companies during the JPMHC period to explore technology transfer opportunities for key research and development (R&D) tasks and seek partnerships for new anti-cancer combination therapies....In addition to BBT-877, discussions on the transfer of global and regional rights to 'BBT-207', a non-small cell lung cancer targeted treatment candidate currently undergoing active clinical trials for patients, are also expected to begin through this meeting."

Clinical • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Bridge Biotherapeutics Announces Initiation of Phase 1/2 Clinical Trial of BBT-207 in EGFR-Mutant NSCLC (PRNewswire) - "Bridge Biotherapeutics...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....The Phase 1/2 study...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)."

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Bio presents anti-cancer project poster at the International Association for Cancer Research conference [Google translation] (Medifonews) - "On the 14th local time, the company disclosed preclinical research data and future clinical plans for BBT-207, which is being developed as a lung cancer clinical project, and BBT-207, a new solid cancer treatment candidate discovered by itself through its US subsidiary Boston Discovery Center (BDC)....In addition, the drug's inhibitory effect on brain metastasis and improvement in survival rate were confirmed through an animal model based on lung cancer cells derived from patients....According to the published poster, BBT-4437 has been shown to bind to the TEAD family broadly (pan-TEAD binder) and selectively (selectivity) through various in vitro studies, including reporter gene assay....In animal model experiments, BBT-4437 also showed excellent antitumor activity."

Preclinical • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics discards NSCLC drug candidate BBT-176 (Korea Biomedical Review) - "Bridge Biotherapeutics announced on Tuesday that it will discontinue the development of BBT-176, a drug candidate for non-small cell lung cancer (NSCLC)...Instead, the company stated it would focus on...BBT-207, candidates for...NSCLC, which have 'greater market potential'....Bridge Biotherapeutics also estimates that the internalization of clinical development functions will reduce costs by about 10 billion won (approximately $7.3 million) for the lung cancer project, and it is also expected to generate new cash flow through cooperation with a number of domestic companies in the bio industry."

Commercial • Discontinued • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: Bridge Biotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trial in progress: First-in-human study of BBT-207 in advanced non-small cell lung cancer harboring EGFR mutation after treatement with EGFR TKI. (AACR-NCI-EORTC 2023) - No abstract available

Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Bio, 4th-generation EGFR lung cancer drug phase 1/2 design disclosure (docdocdoc.co.kr) - "Bridge Biotherapeutics (hereafter referred to as Bridge Bio) presented one clinical project and one non-clinical project at the '2023 AACR-NCI-EORTC', an international academic conference related to cancer research to be held in Boston, USA for five days from October 11th to 15th. It was announced on the 22nd that one poster presentation was confirmed....In this presentation, which is the first since the approval of the clinical trial plan, the outline of the phase 1/2 clinical trial of BBT-207, which is being developed as a fourth-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI), and plan is revealed....Through this poster presentation, various early experimental data of BBT-4437 are revealed. The company plans to establish a development strategy considering various solid carcinomas, such as malignant mesothelioma and tumors containing NF2 mutations."

Clinical protocol • Preclinical • Lung Cancer • Mesothelioma • Oncology • Solid Tumor

Bridge Bio's targeted lung cancer treatment 'BBT-207' phase 1/2 IND approval [Google translation] (eDaily) - "Bridge Bio announced on the 7th that it has decided to approve the Korean Institutional Investigational Initiative (IND) for the phase 1/2 non-small cell lung cancer clinical trial of BBT-207, an EGFR-TKI drug. The clinical trial aims to evaluate the safety and tolerability, pharmacokinetic and pharmacodynamic properties, and efficacy of BBT-207 in patients with advanced non-small cell lung cancer with EGFR mutation after EGFR TKI treatment, and was conducted at 15 to 20 institutions in Korea and the United States will be implemented in the projected end date is August 31, 2028."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI (clinicaltrials.gov) - P1/2 | N=92 | Not yet recruiting | Sponsor: Bridge Biotherapeutics, Inc.

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics to Present at the 2023 BIO International Convention (PRNewswire) - "Bridge Biotherapeutics...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)."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Bridge Biotherapeutics Receives FDA Authorization to Proceed with the First-in-Human Study of BBT-207, a 4th generation EGFR TKI (PRNewswire) - "Bridge Biotherapeutics...announced that it received notice from the U.S....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...NSCLC....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....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."

IND • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

BBT-207 is a broad-spectrum, highly potent, 4th generation EGFR TKI with enhanced activity to both sensitizing and treatment-emergent EGFR mutations including T790M and C797S (AACR 2023) - "BBT-207 also showed IC50 values <5 nM against Osimertinib-resistant EGFR L792H triple mutants, DTL and LTL in cell-free in vitro kinase assay. BBT-207 is a reversible, mutant-specific, broad-spectrum TKI, active to clinically observed mutations of EGFR and is expected to be compatible with monotherapy of QD schedule in humans. BBT-207 is well-positioned to augment the treatment of EGFR mutated NSCLC, either for acquired drug resistance or in earlier line, with potential to treat or prevent CNS metastasis. PK/TK evaluation justify exploration in humans."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics Releases Updated Preclinical Data for BBT-207 at the AACR Annual Meeting (PRNewswire) - "Bridge Biotherapeutics...presented a poster with preclinical data updates of its drug candidate BBT-207 at the American Association for Cancer Research (AACR) 2023 annual meeting....BBT-207 demonstrated dose-dependent tumor regression efficacy against C797S double mutations from in vivo study with Osimertinib-resistant Ba/F3 CDX mouse models. The administration of 40mg/kg for 21 days resulted in significantly regressed tumor growth, with a tumor growth inhibition (TGI) rate of 107% in Del19/C797S (DC) model and 102% in L858R/C797S (LC) model."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Bridge Bio applies for phase 1/2 clinical trial for non-small cell lung cancer treatment in the US [Google translation] (businesspost.co.kr) - "Bridge Bio announced on the 27th that it had applied to the US Food and Drug Administration (FDA) for phase 1/2 clinical trials of 'BBT-207', a treatment for non-small cell lung cancer, on the 24th. This clinical trial is conducted on patients with advanced non-small cell lung cancer with EGFR mutation who have been treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)....We made plans to conduct clinical trials not only in the US but also in Korea."

IND • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bridge Biotherapeutics to Present Updated Preclinical Data of BBT-207 at the AACR 2023 Annual Meeting (PRNewswire) - "Bridge Biotherapeutics...announced that it is presenting a poster on its preclinical drug candidate BBT-207 at the American Association for Cancer Research (AACR) 2023 annual meeting....Preclinical data suggests that BBT-207 may have the potential to be used as a broad-spectrum fourth generation EGFR TKI with anti-tumor effects in EGFR mutant NSCLC....Bridge Biotherapeutics plans to initiate the Phase 1 clinical study of BBT-207, focusing on the treatment of advanced non-small cell lung cancer patients, in the first half of the year."

New P1 trial • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • EGFR

BBT-207, a novel, 4th generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with broad-spectrum activity to both treatment-emergent and drug-naïve mutants for the treatment of NSCLC (AACR 2022) - P1/2 | "Such a 4th generation EGFR TKI must also enable monotherapy, allowing precise dose adjustment in case of toxicity. Derived from BBT-176 which is under clinical evaluation (NCT04820023), we synthesized BBT-207 and other related molecules...Double mutants containing T790M (DT and LT) were inhibited effectively by BBT-207 and Osimertinib at similar concentrations, while not by Gefitinib... BBT-207 is a reversible, mutant-specific, broad-spectrum TKI, active to clinically observed mutations of EGFR and is expected to be compatible with monotherapy of QD schedule in humans. BBT-207 is well-positioned to augment the treatment of EGFR mutated NSCLC, either for acquired drug resistance or in earlier line."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR