CAN017 is a humanized immunoglobulin gamma 1/kappa (IgG1/) monoclonal antibody that targets the human v-erb-b2 oncogene homolog 3 (ERBB3 or HER-3) receptor and inhibits ERBB3 activities. It can bound to human ERBB3 and inhibit binding of the ligand Neuregulin1 (NRG1) to ERBB3 to block the signal pathway which is associated with proliferation and metastasis of tumor cell. CAN017 has been tested on 35 CDX models and 26 PDX models in preclinical studies for its in vivo efficacy and the correlation between efficacy of CAN017 and the expression level of NRG1. It is proven that NRG1-positive tumors are enriched with statistical significance for responders to CAN017 and that the in vivo efficacy of CAN017 can potentially be predicted by NRG1 expression levels in the tumors. The completed phase I study of CAN017 on various metastatic or advanced solid tumors also showed that CAN017 was well tolerated with excellent safety profile. CANbridge will develop CAN017 first in squamous cell esophageal cancer, the predominant form of esophageal cancer in China.
CANbridge has obtained the exclusive global license (excluding North America) for the development, manufacture and commercialization of CAN017.
Indication：Esophageal Squamous Cell Carcinoma
Esophageal cancer is a gastrointestinal cancer. The two main sub-types of the disease are esophageal squamous-cell carcinoma (often abbreviated to ESCC), which is more common in China and other Asian countries, and esophageal adenocarcinoma (EAC), which is more common in developed countries.
As of 2018, esophageal cancer was the seventh-most common cancer globally with 572,000 new cases during the year. It caused about 500,000 deaths that year, up from 345,000 in 1990. Rates vary widely among countries, with about half of all cases occurring in China. Epidemiological report released by National Cancer Center in 2019 showed that esophageal cancer ranks as top six cancer in terms of morbidity and top four of mortality in China, according to National Cancer Center. Outcomes are related to the extent of the disease and other medical conditions, but generally tend to be fairly poor, as diagnosis is often late. Five-year survival rate is usually lower than 20%.
Resection, radiotherapy and chemotherapy are the options for esophageal cancer. However, 5-FU, taxane and platinum are still the limited treatment for the advanced and metastatic disease.