Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8010, an Antibody Drug Conjugate Targeting HER2 for the Treatment of Advanced Solid Tumors

Bio-Thera Solutions, 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 for the treatment of solid tumors. 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.