Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors.

BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2 designed for the treatment of solid tumors. Trop2 (Trophoblast cell-surface antigens 2), also known as TACSTD2, M1S1, GA733-1, EGP-1, is a member of tumor associated calcium signal transduction protein (TACSTD) family, which is related to the regulation of intracellular calcium concentration.

Trop2 is not expressed or has low expression levels in normal human tissues while overexpressed in a variety of solid tumors, especially epithelial tumors including breast cancer, cervical cancer, colorectal cancer, esophageal cancer, gastric cancer, lung cancer, oral squamous cell cancer, ovarian cancer, prostate cancer, pancreatic cancer, thyroid cancer, urinary bladder cancer, uterine cancer, glioma, etc. High expression levels of Trop2 in tumors is correlated with poor prognosis for patients. Trop2 is a validated drug target with one approved drug for the treatment of solid tumors and is a target of high interest for new drug discovery.

BAT8008 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8008 has a strong cell membrane penetration ability. Consequently, when targeted cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8008 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Preclinical data generated using BAT8008 was presented in a poster at the 2022 San Antonio Breast Cancer Conference (http://doi.org/10.1158/1538-7445.SABCS22-P4-01-32).

Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Her2, Nectin-4. All the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular and eye diseases, and other severe and emerging unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products, QLETLI^®, POBEVCY^® and BAT1806 in China. In addition, the company has 25 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. 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 BAT8008 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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