SINO BIOPHARM: LM-350 "CDH17 ADC" completes the enrollment of the first patient in Phase I clinical trial in Australia
SINO BIOPHARM announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology, has completed the enrollment of the first patient in the Phase I clinical trial of the innovative drug LM-350 "CDH17 ADC" in Australia, marking the entry of this drug into the clinical development stage. LM-350 is an antibody-drug conjugate targeting CDH17, demonstrating significant anti-tumor activity, particularly in certain drug-resistant colorectal cancer cells. The study will evaluate the safety and preliminary efficacy of LM-350 in patients with advanced solid tumors
According to the announcement from SINO BIOPHARM (01177), its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. ("Lixin Pharmaceutical"), has successfully completed the enrollment of the first patient in the Phase I clinical trial of the national Class 1 innovative drug LM-350 "CDH17 antibody-drug conjugate (ADC)" in Australia, marking the official entry of this innovative therapy into the clinical development stage.
LM-350 is an ADC targeting CDH17 developed based on Lixin Pharmaceutical's next-generation ADC technology platform LM-ADCTM, which can selectively bind to CDH17 with high specificity and has strong internalization capability. LM-350 adopts the IgG1 wild-type configuration and possesses antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Preclinical studies have shown that LM-350 exhibits significant anti-tumor activity in multiple xenograft models, particularly effective in colorectal cancer cells resistant to MMAE or irinotecan.
CDH17 plays an important role in the invasion and metastasis of various tumors and is highly expressed in approximately 99% of colon cancer, 86% of gastric adenocarcinoma, 79% of esophageal adenocarcinoma, and 50% of pancreatic ductal adenocarcinoma. Gastrointestinal tumors (including colorectal cancer, gastric cancer, pancreatic cancer, esophageal cancer, etc.) are among the highest incidence and mortality cancer types globally, with over 4 million new patients reported worldwide in 2022, indicating a significant unmet clinical need.
This clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of LM-350 in patients with advanced solid tumors. The group will continue to rapidly advance the clinical research of the project, looking forward to providing new clinical treatment options for patients soon
