On March 30, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials (Press release, BioThera Solutions, MAR 30, 2022, View Source [SID1234611201]).
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"BAT6026 has demonstrated highly potent anti-tumor activity as a single agent and in combination with BAT1308 in in vivo pharmacology studies." said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. To date, anti-OX40 antibodies as agonists have not delivered optimal clinical responses, and recent studies revealed that their activities correlate directly to antibody isotypes and Fc functions, suggesting that Treg depletion might be important in improving clinical outcomes. BAT6026 has demonstrated potent Treg depletion activity, while synergistically activating T effector cells.
This Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of the combination of BAT6026 and BAT1308 in advanced solid tumor patients. Key objectives in the study include determining maximum tolerated dose and recommended Phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6026 in a variety of malignancies thereafter. In addition, BAT6026 has previously entered a monotherapy clinical study in China.
Bio-Thera Solutions is developing several innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, TIGIT and IO bispecifics targeting synergistic targets like PD-L1/CD47. Bio-Thera recently disclosed its next generation Antibody-Drug Conjugate (ADC) platform that has generated clinical candidate for important and validated tumor target like Folate Receptor alpha.