Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress in addressing the unmet needs of patients with Exon20ins mutations.
ABSK112: A Promising EGFR Inhibitor for Exon20ins Mutation
ABSK112 is a next-generation EGFR inhibitor that has shown activity against Exon20ins mutations, a challenging subset of NSCLC. In preclinical studies, Abbisko’s molecule has demonstrated superior blood-brain barrier penetration, enhanced selectivity for wild-type EGFR, and a broader coverage spectrum for Exon20ins mutations compared to similar products that are either listed or in clinical stages.
Preclinical Efficacy and the Path to Clinical Trials
Preclinical testing of ABSK112 has yielded excellent in vivo efficacy in various EGFR Exon20ins mutated mouse tumor models. These promising results have paved the way for the initiation of a global Phase I clinical study, which will further evaluate the safety, tolerability, and preliminary efficacy of ABSK112 in patients with NSCLC harboring Exon20ins mutations.-Fineline Info & Tech
