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Antengene said Friday that the first patient in China has received ATG-201 in a Phase I trial of the experimental antibody treatment for adults with B cell-mediated autoimmune diseases.
The ATTRACT study will evaluate the treatment’s safety, tolerability and preliminary activity, the company said in a November 6 announcement. The trial programme covers China and Australia.
Testing a treatment that recruits immune cells
ATG-201 is a bispecific antibody designed to bind to CD19 on B cells and CD3 on T cells. The intended approach uses T cells to eliminate CD19-expressing B cells involved in autoimmune disease, according to Antengene.
The study is led by Professor Zhanguo Li of Peking University People’s Hospital. It has two parts: dose escalation, in which researchers test increasing doses, and dose expansion to further evaluate selected doses.
Its primary objectives are to assess safety and tolerability and identify a recommended dose for Phase II testing. Researchers will also examine how the treatment behaves in the body, its effects on immune activity, immune responses to the drug and early signs of effectiveness.
China and Australia trial programme
For patients and families following new autoimmune treatments, the immediate development is the start of dosing in an early clinical study. The programme is designed to establish the treatment’s safety profile and a dose for further testing.
Antengene said the Australian programme has received Human Research Ethics Committee approval and completed the Therapeutic Goods Administration’s Clinical Trial Notification process.
Under an agreement with UCB, that company holds worldwide exclusive rights to further develop, manufacture and commercialize ATG-201. Antengene is conducting the Phase I trials in China and Australia.
JBizNews Desk | Hong Kong
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