Bio-Thera Solutions Announces First Patient Dose in Phase 1 Study for BAT8006, an Antibody-Drug Conjugate Targeting the Folate α Receptor for the Treatment of Advanced Solid Tumors

GUANGZHOU, CHINA–(BUSINESS WIRE)–Bio-Thera Solutions, Ltd. (HS:688177), a commercial-stage pharmaceutical company, today announced that dosing has commenced in a Phase 1 clinical study evaluating BAT8006, an antibody-drug conjugate (ADC) that targets the folic acid receptor α (FRα). The clinical trial is a multicenter, open-label, Phase 1 clinical study in patients with advanced solid tumors to assess the safety and tolerability of BAT8006 and to determine the recommended Phase 2 dose.

FRα is a folic acid binding protein located on cell membranes that is overexpressed in a variety of solid tumors such as ovarian, lung, breast cancers, etc., but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make FRα an ideal target for ADC drug development. BAT8006 was developed using Bio-Thera’s anti-FRα antibody and Bio-Thera’s proprietary ADC-payload combination which includes a systemically stable and cleavable linker and a small molecule topoisomerase I inhibitor. A series of preclinical studies have shown that BAT8006 has good stability and safety and has high anti-tumor activity. The small molecule topoisomerase I inhibitor payload carried by BAT8006 has a strong ability to penetrate the cell membrane, so when the target cancer cells are killed, the payload can be released and further kill the cells nearby cancer cells, producing a bystander effect and effectively overcoming tumor heterogeneity. BAT8006 demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacology studies and is a potential “best-in-class” ADC that targets FRα. BAT8006 is the first ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another milestone in the company’s research and development in the area of ​​innovative oncology drugs.

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT8006 is designed to evaluate the safety and tolerability of BAT8006. The main objectives of the study are to determine the maximum tolerated dose and the recommended phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumors. Additionally, Bio-Thera Solutions is developing several additional ADCs targeting B7H3, Her2 and two other targets, as well as additional innovative oncology assets for important IO targets including PD-1, OX40, CTLA-4 and TIGIT, all in early phase. stage of clinical studies.

About Bio-Thera Solutions

Bio-Thera Solutions, Ltd., a leading global biotechnology company based in Guangzhou, China, is dedicated to the research and development of novel therapies for the treatment of cancer, autoimmune, cardiovascular and cardiovascular diseases. other serious unmet medical needs, as well as biosimilars for , branded biologics to treat a range of cancers and autoimmune diseases. A leader in the discovery and engineering of next-generation antibodies, the company has advanced six candidates in late-stage clinical trials and has two approved products, QLETLI® and POBEVCY® in China. Additionally, the company has several promising candidates in early clinical trials and studies enabling IND, focusing on immuno-oncology, ADC-targeted therapies, autoimmune diseases and other serious medical needs. and emerging unsatisfied. For more information, please visit www.bio-thera.com/fr/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

Caution Regarding Forward-Looking Statements

This press release contains certain forward-looking statements relating to BAT8006 or Bio-Thera Solutions’ product pipelines generally. Readers are strongly cautioned that reliance on forward-looking statements involves known and unknown risks and uncertainties. Forward-looking statements include, but are not limited to, those that contain “could”, “could”, “should”, “will”, “should”, “anticipate”, “believe”, “plan”, “promising”, “potentially”. . », or similar expressions. They reflect the Company’s current views regarding future events which are based on what the Company considers to be reasonable assumptions based on information currently available to Bio-Thera Solutions, and are not guarantees of future performance or developments. Actual results and events may differ materially from the information contained in forward-looking statements due to a number of factors, including, but not limited to, the risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of preclinical studies and clinical studies, for example, the development processes could be long and high in vitro affinity may not translate to desired results live or successful clinical studies. Other risks and uncertainties include difficulties in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in the global healthcare situation, changes in the company’s financial conditions and changes in applicable laws and regulations, etc. the forward-looking statements contained herein speak only as of the date of their initial publication. Unless required by law or regulation, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in company opinions or otherwise.

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