China-based Akeso Biopharma (HKG: 9926) has announced a strategic partnership with fellow Chinese firm LaNova Medicines to advance a series of clinical studies. The collaboration will assess a combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), with LaNova’s LM-302, a potential best-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2). The trial will focus on general solid tumor types.
Study Details and Objectives
The study will be conducted in mainland China, including a Phase II trial in advanced digestive tract tumors, alongside investigator-initiated trials. The primary objectives are to determine the dosage, administration frequency, safety, and efficacy of the combination therapy.
AK112: A Leading PD-1/VEGF Bispecific Antibody
Akeso’s in-house discovery, AK112, is the world’s first PD-1/VEGF BsAb to enter Phase III trials. It blocks the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. The product has received three breakthrough therapy designations (BTDs) in China and is currently undergoing Phase III clinical studies in first-line PD-L1 positive non-small cell lung cancer (NSCLC) compared with Keytruda, as well as in advanced non-squamous NSCLC with EGFR TKI resistant EGFR mutations.
LM-302: Targeting CLDN18.2-Positive Tumors
LM-302 is designed to target CLDN18.2-positive tumor cells to deliver a small-molecule toxin. The drug has received three Orphan Drug Designations (ODDs) in the US for the treatment of pancreatic cancer, gastric or gastroesophageal junction cancer, and cholangiocarcinoma. It is currently undergoing Phase II clinical trials in China and Phase I clinical trials in the US and Australia. LaNova signed an agreement with US firm Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to out-license LM-302 for development and commercialization globally outside the Greater China and South Korea markets.-Fineline Info & Tech
