Biotech company Bridge Biotherapeutics Inc reported on Sunday the receipt of clearance from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for BBT-176 for advanced non-small cell lung cancer (NSCLC).
The South Korean company said BBT-176, a novel epidermal growth factor receptor - tyrosine kinase inhibitor (EGFR-TKI), is designed to inhibit EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in NSCLC.
Under the company's pre-clinical studies, BBT-176 exhibited strong anti-tumour efficacy in C797S triple mutations as well as displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.
Additionally, the company will launch a dose escalation study under the first phase I/II study in Korea to find the maximum tolerated dose (MTD) and to observe safety, tolerability and anti-tumour efficacy of BBT-176 in the patient groups of advanced NSCLC.
In conjunction, will company will access the safety, tolerability and efficacy along with the best MTD of the drug candidate in the US and Korea in the second part of the dose expansion study.
Lung cancer is reportedly the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is split into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers.
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax