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The first subjects in the phase I study of TOT BIOPHARM antibody-coupled drug were enrolled for administration

发布时间:2018-12-20

On December 18, TOTBIOPHARM announced that its phase I clinical trial of Antibody Drug Conjugate (ADC) TAA013 has successfully completed its first patient enrollment. TAA013 for injection is intended to treat HER2 positive breast cancer patients. Currently, there is no antibody-coupled drug for the treatment of this tumor on the market in China.

TAA013 for injection is an antibody conjugated drug developed independently by TOT BIOPHARM by coupling the ligon with the highly active substance DM1. TAA013 for injection has the same affinity with trastuzumab for HER2. After its binding, it enters tumor cells through receptor-mediated endocytosis, and DM1 only dissociates from the cells to inhibit microtubule polymerization, leading to the death of tumor cells. In addition, the vial TAA013 with the combination of HER2 and Fc gamma R activity, has the same HER2 and by bead sheet resistance cell proliferation inhibitory activity and antibody dependent cell mediated cytotoxicity (antibody - dependentcell - mediated cytotoxicity, ADCC).

Therefore, in addition to having the same anti-tumor effect as trastuzumab, TAA013 can also deliver DM1 with high cytotoxicity but low therapeutic index to target cells, which can not only improve the safety, but also play a stronger anti-cancer effect and significantly reduce the recurrence rate of patients.

Breast cancer is the most important malignant tumor that endangers women's health. Every year, about 1.4 million women suffer from breast cancer, among which about 400,000 die. In recent years, the incidence of breast cancer in China has been increasing year by year. About 2 out of every 10 patients are HER2 positive, which has become the "no. 1 killer" threatening women's health. A positive HER2 indicates a higher degree of malignancy, faster progression of the disease, a higher risk of metastasis and recurrence, and a poor prognosis.