China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), is on course for priority review for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations that progress after treatment with EGFR tyrosine kinase inhibitor (EGFR TKI) combined with pemetrexed plus carboplatin. The drug has previously obtained breakthrough therapy designation (BTD) statuses for three lung cancer indications.
Dual-Targeting BsAb and Synergy in Anti-Tumor Effects
AK112 blocks the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. This dual-targeting approach positions ivonescimab as a potential new option for patients with NSCLC, particularly those with EGFR mutations who have progressed after initial treatment.
Global Partnership with Summit Therapeutics
Akeso struck a significant deal with US firm Summit Therapeutics Inc. (NASDAQ: SMMT) in December 2022, granting Summit exclusive development and commercialization rights to the drug in the US, Canada, Europe, and Japan. This partnership underscores the global potential of ivonescimab and Akeso’s commitment to expanding access to innovative cancer treatments.
Regulatory Phase III Clinical Studies and Marketing Review in China
Ivonescimab is currently under marketing review in China and is undergoing four regulatory Phase III clinical studies in NSCLC, including three head-to-head trials with PD-1 inhibitors as positive controls. These studies are crucial for demonstrating the efficacy and safety of ivonescimab in comparison to existing treatments, further supporting its potential approval and use in the global market.-Fineline Info & Tech
