Therapy Areas: Cardiovascular
First Patient Dosed in Phase 1 Study for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Advanced Solid Tumors
15 July 2022 - - Dosing has begun in a Phase 1 clinical study evaluating BAT8006, an antibody drug conjugate that targets folic acid receptor α, China-based commercial-stage pharmaceutical company Bio-Thera Solutions, Ltd. (SH: 688177) said.

The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate 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 cancer, 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 linker-payload combination that 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 cell membrane penetration ability, so when the target cancer cells are killed, the payload can be released and further kill nearby cancer cells, producing a bystander effect and effectively overcoming the heterogeneity of the tumor.

BAT8006 has demonstrated high anti-tumor activity and good safety in both in vitro and in vivo pharmacological 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 important milestone in the company's research and development in the field of innovative oncology drugs.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8006 is designed to assess the safety and tolerability of BAT8006.

Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose, and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor.

In addition, Bio-Thera Solutions is developing several additional ADCs targeting B7H3, Her2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early-stage clinical studies.

Bio-Thera Solutions, Ltd., a 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.
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