China-based Akeso Biopharma (HKG: 9926) has entered into a strategic partnership with compatriot firm LaNova Medicines to advance a series of clinical studies. These studies will assess the combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), alongside 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.
Phase II Trial and Investigator-Initiated Studies in Mainland China
The study will be conducted in mainland China, including a Phase II trial in advanced digestive tract tumors, along with investigator-initiated trials. The aim is to determine the dosage, administration frequency, safety, and efficacy of the combined therapy.
AK112: The World’s First PD-1/VEGF BsAb in Phase III Trials
Akeso’s in-house discovery, AK112, is the world’s first PD-1/VEGF BsAb to enter into Phase III trials. It blocks the PD-1 and VEGF pathways simultaneously, aiming to produce synergistic anti-tumor effects. AK112 has received three breakthrough therapy designations (BTDs) in China and is currently undergoing a Phase III clinical study in first-line PD-L1 positive non-small cell lung cancer (NSCLC) compared with Keytruda. Additionally, it is involved in a Phase III clinical study combined with chemotherapy in advanced non-squamous NSCLC with EGFR TKI resistant EGFR mutations. The drug has also been approved in China for a Phase III study in first-line advanced squamous NSCLC combined with chemotherapy.
LM-302: Targeting CLDN18.2-Positive Tumor Cells
LM-302 can 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. LM-302 is 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
