Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as a potential treatment for non-small cell lung cancer (NSCLC). The drug has already secured IND approval in the US earlier this year in July.
ABSK112: A Promising Molecule
ABSK112 has shown promising results in preclinical studies, demonstrating superior blood-brain barrier penetration, enhanced selectivity for wild-type EGFR, and a broader spectrum of Exon20ins mutation coverage compared to existing or developing similar products. These attributes are critical for the treatment of NSCLC, a disease that often requires drugs capable of targeting specific mutations effectively.
Preclinical Efficacy and Next Steps
Preclinical testing of ABSK112 has yielded excellent in vivo efficacy in various EGFR Exon20ins mutated mouse tumor models. This strong preclinical performance lays the groundwork for the upcoming Phase I clinical study, which will be crucial in determining the drug’s safety and preliminary efficacy in humans. The initiation of clinical trials marks a significant milestone for Abbisko Therapeutics as it advances its pipeline of innovative cancer treatments.-Fineline Info & Tech
