LaNova Medicines Receives FDA IND Clearance for LM-350, a Novel CDH17-Targeting ADC

Shanghai, July 24, 2025 – LaNova Medicines Ltd. announced today that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for LM-350, its innovative antibody-drug conjugate (ADC) targeting CDH17.

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^[3].

References:

[1] World Journal of Cancer Research, 2021, 11: 131.

[2] Panarelli NC, Yantiss RK, Yeh MM, Liu Y, Chen YT. Am J Clin Pathol. 2012 Aug;138(2):211-22.

[3] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA: a cancer journal for clinicians, 2024, 74(3): 229-263.