First EU trial begins of Chinese-made biologic

Prima BioMed Ltd. (ASX:PRR; NASDAQ:PBMD) and its manufacturing partner WuXi AppTec Co. Ltd. said a Belgian patient in the Phase IIb AIPAC trial was dosed with Prima's IMP321 -- the first time a patient in the EU has received a Chinese-manufactured biologic, according to the partners. IMP321 is a natural human T cell immunostimulatory factor derived from soluble lymphocyte-activation gene 3 ( LAG3; CD223).

The double-blind, placebo-controlled Phase IIb trial is evaluating IMP321 as an adjunctive treatment for metastatic breast cancer. Its primary endpoint is progression-free survival (PFS). ...