On January 21, 2021 Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, reported 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 (Press release, BioThera Solutions, JAN 21, 2021, View Source [SID1234574185]).

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"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.