Bridge Biotherapeutics said that it has presented the preclinical data of BBT-176, a non-small cell lung cancer (NSCLC) treatment, during the 2021 European Society for Medical Oncology (ESMO) Congress.
“We have presented the preclinical research data related to the tumor suppression efficacy of BBT-176, the cell-based drug efficacy evaluation results for the C797S double mutation, and the status and plan of the phase 1/2 clinical trial for NSCLC patients with non-small cell lung cancer via an e-poster during the ESMO 2021,” the company said.
As a result of administering BBT-176 once a day for 31 days in a mouse model transplanted with patient-derived cancer tissue, the company confirmed a reduction in the relative size of the tumor compared to the baseline, according to the published poster.
“Through the pharmacodynamic analysis of biomarkers, we confirmed that various indicators related to tumor growth decreased in proportion to the dose of the drug, the company said. “Regarding administering BBT-176 once a day for six weeks in an estimated glomerular filtration rate (EGFR) triple mutation-induced mouse tumor model including C797S, we confirmed suppression for brain metastases compared to baseline.”
Encouraged by the non-clinical data demonstrating tumor regression efficacy in NSCLC with EGFR mutations, Bridge Biotherapeutics designed the first-in-human (FIH) study of BBT-176 and began patient dosing in Korea in April.
“We plan to additionally secure drug safety and efficacy data for various races by adding participating clinical institutions in the U.S. within this year,” the company said. “Once the maximum tolerated dose (MTD) and determined the recommended phase 2 dose (RP2D) and conduct dose-expansion trials in the U.S. and Korea.”
In parallel with the clinical development of BBT-176, the company will also continue to expand its NSCLC solutions, utilizing precision medicine accompanied by companion diagnostic devices, it added.
Bridge Biotherapeutics Chief Medical Officer Lee Sang-yoon said, “We are proud to present the exploratory efficacy data from our preclinical studies for BBT-176, our first-ever oncology pipeline, to both European and international oncologists.”
By accelerating the company’s development of fourth-generation EGFR TKIs, the company will try its best to address the unmet medical needs of patients with NSCLC, Lee added.