On December 29, 2021 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6005, a monoclonal antibody targeting TIGIT in cancer patient volunteers (Press release, BioThera Solutions, DEC 29, 2021, View Source [SID1234597828]). BAT6005 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform, and it has normal IgG1 ADCC function.

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"TIGIT is an immune-oncology drug target of significant interest. Preclinical data generated in support of the BAT6005 IND is very promising." Said Dr. Jin-Chen Yu, SVP, Bio-Thera Solutions. "BAT6005 is one of several IO assets that are entering Phase 1 studies and transition Bio-Thera’s innovative IO pipeline from primarily a preclinical pipeline to a clinical pipeline. We plan to explore combinations of BAT6005 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 BAT6005 is designed to assess the safety and tolerability of BAT6005 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.