GUANGZHOU, China I January 21, 2021 I Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers.

“PD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile.” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a broad range of cancers.”

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT1308 is designed to assess the safety and tolerability of BAT1308 as a single agent. The study is expected to enroll subjects with advanced solid tumor. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.

Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including TIGIT, CTLA4, OX40, CD47 and TGFβ and IO bispecifics targeting synergistic targets like PD-L1/CD47.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has one approved product, QLETLI, in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

SOURCE: Bio-Thera Solutions