GUANGZHOU, China I December 29, 2021 I Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6026, an agonist monoclonal antibody targeting OX40 in cancer patient volunteers. BAT6026 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform. The Antibody Dependent Cellular Cytotoxicity (ADCC) of BAT6026 has been enhanced through significant afucosylation of BAT6026.

“OX40 is an important immune-oncology and autoimmune drug target. We are very excited about the preclinical profile of BAT6026, both as a single agent and in combination with other immune-oncology (IO) agents.” said Dr. Jin-Chen Yu, SVP, Bio-Thera Solutions. “BAT6026 is one of multiple IO assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs) through enhanced ADCC effects. We plan to explore combinations of BAT6026 with BAT1308, our novel PD-1 antibody, to treat a broad range of cancers.”

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT6026 is designed to assess the safety and tolerability of BAT6026 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.

About IDEAL Platform

Bio-Thera Solutions has developed a proprietary fully synthetic human antibody discovery platform called IDEAL, which stands for Intelligent Design and Engineered Antibody Libraries Platform. The CDR-H3 of our novel innovative antibodies is designed based on over 100,000 natural human antibody sequences. Our IDEAL library has an overall diversity of CDR-H3 over 3E+11. Fixed clinically proven frameworks are utilized to increase the odds of development. A universal affinity maturation library is used for all candidates. A fast high-throughput screening platform is employed.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical 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. As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and two of them, QLETLI® and POBEVCY®, are available to patients in China. In addition, the company has multiple candidates in early stage clinical or entering clinical studies, including differentiated and innovative anti-OX40, anti-TIGIT, and anti-PD-L1/CD47 bispecific antibodies. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

SOURCE: Bio-Thera Solutions