Bridge Biotherapeutics, an innovative new drug research and development company, announced on the 7th that it was administered to patients who participated in the first phase 1/2 clinical trial of BBT-176, the next-generation lung cancer target anticancer drug candidate.
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 such as tagriso (ingredient name osimertinib) in non-small cell lung cancer (NSCLC). Bridge Biotherapeutics has secured data on 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 EGFR mutations, and liquid biopsy that analyzes the mutation information of tumor cells more quickly through tumor genes in the blood. ) We plan to closely grasp patient group data by mutation by applying procedures, etc.
Next, in the Dose Expansion Study, which is expected to enter Korea and the United States within the year, ▲Objective Response Rate (ORR), ▲Reaction Duration (DoR) and ▲Nothing in accordance with the Solid Tumor Response Evaluation Criteria (RECIST) version 1.1. By evaluating advanced survival (PFS), etc., we plan to examine the antitumor activity of BBT-176 in the selected mutant types. The clinical trial will be conducted on about 90 patients.
Bridge Biotherapeutics CEO Jeong-gyu Lee said, “I think it is meaningful to be the first to start clinical trials of BBT-176, a new anticancer drug 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 ensure that clinical trials are carried out quickly and with full accuracy, and at the same time, we are also spurring business development so that global licensing opportunities can be explored by preparing for the later development stage. I will do 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 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.