Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced 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.

“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.

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 six candidates into late-stage clinical trials and has two approved products, QLETLI® and POBEVCY® in China. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on immuno-oncology, ADC targeted therapies, autoimmune diseases, and other severe and emerging unmet medical needs. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and wechat (Bio-Thera).

Cautionary Note Regarding Forward-Looking Statements

This news release contains certain forward-looking statements relating to BAT6026, BAT1308 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.

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