On July 24, 2025 LaNova Medicines Ltd. reported that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for LM-350, its innovative antibody-drug conjugate (ADC) targeting CDH17 (Press release, LaNova Medicines, JUL 24, 2025, View Source [SID1234656026]).
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LM-350 was developed using LaNova’s next-generation ADC platform, LM-ADC. It is a highly selective ADC that targets cadherin-17 (CDH17) with strong internalization capacity. The molecule features a wild-type IgG1 backbone and retains antibody-dependent cell-mediated cytotoxicity (ADCC) activity. In preclinical studies, LM-350 demonstrated potent anti-tumor efficacy across multiple xenograft models, with particularly strong activity in colorectal cancer cells resistant to MMAE or irinotecan.
CDH17 plays a key role in tumor invasion and metastasis and is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas [1,2] .Gastrointestinal (GI) cancers—including colorectal, gastric, pancreatic, and Esophageal cancers—are among the most prevalent and deadly cancer types worldwide. In 2022, global incidence exceeded 4 million cases, underscoring the significant unmet medical need in this area.