Leap Therapeutics

Claudin18.2 targeted therapy market sees Vyloy (zolbetuximab) approval in 2024, with over 60 drugs in clinical trials, focusing on gastric cancer and expanding to other tumors. China emerges as a key innovator, with Innovent, MabWorks, and Biotheus leading progress.

Leap Therapeutics reports Q3 2024 financials, including completion of enrollment in Phase 2 DeFianCe study for DKN-01 in advanced colorectal cancer, and initiation of FL-501 development. Net loss was $18.2 million, with cash and cash equivalents totaling $62.8 million.

DKN-01 (DKK1-neutralizing antibody) combined with tislelizumab and chemotherapy showed 73% objective response rate in advanced gastric/gastroesophageal junction adenocarcinoma patients, with 95% disease control rate. Median progression-free survival was 11.3 months, and overall survival was 19.5 months. Grade ≥ 3 adverse events occurred in 60% of patients, with one treatment-related death. A randomized phase II trial is ongoing.

Astellas secures FDA approval for Vyloy, its first-in-class CLDN18.2-targeting cancer therapy, for certain gastric cancers. Vyloy, already approved in Japan, EU, and GB, demonstrated reduced risk of disease progression or death in SPOTLIGHT and GLOW trials. The FDA also cleared a CLDN18.2 diagnostic test from Roche for patient eligibility.

Leap Therapeutics appoints Richard L. Schilsky, MD, to its Board of Directors, effective September 1, 2022. Schilsky brings 40+ years of experience in medicine and clinical research, specializing in cancer drug development and clinical trials.