On April 7, 2021 Bridge Biotherapeutics, a research and development company for innovative new drugs, reported that the first phase of clinical trials for BBT-176, a candidate for the next-generation lung cancer target anticancer drug, began in earnest, and that it was administered to patients participating in the clinical trial on the 2nd (Press release, Bridge Biotherapeutics, APR 7, 2021, View Source;pn=6&sn=1&idx=64 [SID1234577708]).
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BBT-176 is a novel epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) targeting the C797S specific EGFR mutation. The C797S mutation is known as an acquired resistance mutation that appears after treatment with tagriso (ingredient name: osimertinib) in Non-small Cell Lung Cancer (NSCLC). Bridge Biotherapeutics has secured data related to the tumor suppression effect of brain metastasis, including the tumor suppression effect against the C797S positive triple mutation in animal models, through the preclinical development previously advanced.
This clinical trial, which is first initiated by three domestic institutions, targets patients with locally advanced or metastatic non-small cell lung cancer with an EGFR mutation. ) We plan to closely grasp patient group data by mutation by applying procedures, etc.
BBT-176 In the first phase of clinical phase 1/2, the Dose Escalation Study evaluates the safety and tolerability of the drug to be tested to determine the recommended phase 2 dose. Next, in the Dose Expansion Study, which is expected to enter Korea and the United States within this year, ▲ Objective Response Rate (ORR), ▲ Objective Response Rate (ORR) according to version 1.1 of the Solid Tumor Response Assessment (RECIST) ; Duration of Response) and ▲ Progress-free Survival (PFS). The clinical trial is planned to be conducted on about 90 patients.
Bridge Biotherapeutics CEO Jeong-gyu Lee said, "I think it is meaningful to be the first to start the clinical trial of BBT-176, a new anticancer drug candidate targeting C797S mutant non-small cell lung cancer, in Korea, which has no treatment options worldwide." Based on the development strategy, the entire development team will do their best to conduct the clinical trials with full accuracy and speed based on the development strategy. I will add it."
More detailed information related to the BBT-176 clinical trial, which was launched this time , can be found in the Clinical Trial Information menu in the Korea Food and Drug Administration’s Integrated Drug Information System website .
On the other hand, Bridge Biotherapeutics, which started to discover its own candidates this year, started to discover and develop new candidates for non-small cell lung cancer drugs that can effectively meet various unmet medical demands, including C797S double mutation.