GUANGZHOU, China I March 06, 2023 I Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8010, an antibody-drug conjugate (ADC) that targets HER2. The multicenter, open-label Phase 1 clinical study in patients with local advanced or metastatic solid tumors aims to evaluate the safety and tolerability of BAT8010. 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 tumor.

BAT8010 is an antibody-drug conjugate (ADC) targeting HER2 designed for the treatment of solid tumors. HER2, a member of the epidermal growth factor receptor family (EGFR), is overexpressed in a variety of solid tumors, plays an important role in tumor proliferation, invasion, and metastasis, and is related to the poor prognosis of tumors. HER2 is a validated drug target with a number of approved drugs for the treatment of breast and gastric cancer and is still a target of high interest for new drug discovery.

BAT8010 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 BAT8010 has a strong cell membrane penetration ability, when the target 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. BAT8010 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Trop2, Nectin-4. All of the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

In addition, Bio-Thera has developed an ADCC-enhanced anti-HER2 monoclonal antibody, BAT1006, that is also in early-stage clinical development. Different HER2 recognition sites can effectively inhibit the formation of HER2/HER3 heteromer. With different HER2 recognition sites and functional synergy, a combination therapy of BAT1006 and BAT8010 has the potential to improve the efficacy of targeting HER2. Bio-Thera intends to explore such a combination upon completion of the Phase 1 studies of each asset.

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 or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).

SOURCE: Bio-Thera Solutions