Luye Pharma Group today announced that the first patient has been enrolled in a Phase I clinical trial for BA1105, an investigational anti-Claudin18.2 antibody developed by its subsidiary Boan Biotech. The Phase I clinical trial is designed to evaluate the safety, tolerance and pharmacokinetics of BA1105 in patients with advanced solid tumors.
BA1105 is a recombinant human anti-Claudin18.2 IgG1 monoclonal antibody for treating Claudin18.2-positive advanced solid tumors. Claudin18.2 is a potential target for treating gastrointestinal tumors. It is consistently and highly expressed in gastrointestinal tumors. Research shows that 70% of gastric cancer patients, 50% of pancreatic cancer patients and 30% of esophageal cancer patients are Claudin18.2 positive.
The incidence of gastrointestinal tumors in China is very high, and there are many unmet needs of patients to be addressed. According to data from the International Agency for Research on Cancer (IARC), gastric cancer, esophageal cancer, and pancreatic cancer are among the 10 most common malignant cancers in China, with the number of new cases in 2020 being approximately 480,000, 320,000, and 120,000, respectively1. More than 40% of the new gastric cancer cases worldwide are in China. Due to the lack of early diagnosis, most gastric cancer patients are diagnosed at an advanced stage. There are limited therapy options for advanced gastric cancer and more effective therapies are needed to improve patient survival. Antibodies targeting Claudin18.2 are promising drugs against gastrointestinal tumors.
Unlike the common ADCC-enhancing technique that decreases the antibody's fucose level through cell engineering, BA1105 enhances ADCC by inducing amino acid mutations in the Fc region. These mutations increase BA1105's affinity to the agonistic Fc receptor without altering its affinity to the inhibitory receptor CD32b, to prevent the drug’s antitumor activity from being inhibited by the inhibitory receptor.
An in vivo efficacy study for BA1105 showed that it demonstrated a high antitumor activity in tumor models with low or high Claudin 18.2 levels either alone or in combination with chemotherapeutic agents. In vitro efficacy studies showed that BA1105 was 10-fold more potent than the reference antibody against cancer cells with either low or high Claudin 18.2 levels. BA1105 is expected to become the best-in-class targeted therapy for certain cancers such as the metastatic pancreatic cancer, the advanced gastric cancer, and the gastro-esophageal junction (GEJ) adenocarcinoma.
Boan Biotech has been building a diversified product portfolio focusing on innovative biologics. In addition to BA1105, the company's R&D pipeline also includes more than 10 other proprietary innovative antibody candidates and various biosimilar candidates, and some of them are undergoing clinical trials in the United States, Europe, China, and other countries and regions around the world. The company is accelerating its global development, and is committed to serving patients around the world with high-quality biopharmaceutical products.