Bio-Thera Solutions Announces First Patient Dosed in Study for the Treatment of Advanced Solid Tumors

Bio-Thera Solutions, a commercial-stage pharmaceutical company, has announced that dosing has begun in a Phase 1 clinical study evaluating BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8007. Key objectives of the Bio-Thera 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.

BAT8007 is an antibody-drug conjugate (ADC) targeting Nectin-4 designed for the treatment of solid tumors. Nectin-4 (Nectin cell adhesion molecule 4) belongs to the nectin subfamily of immunoglobulin-like adhesion molecules that participate in Ca(2+)-independent cell-cell adhesion. Nectin-4 has high expression levels in a normal embryo and fetal tissues, while those expression levels decline in adulthood and has limited distribution in healthy tissues.

Nectin-4 is overexpressed in a variety of solid tumors, such as urothelial carcinoma, breast cancer, non-small cell lung cancer, pancreatic cancer, esophageal cancer and head and neck cancer, etc. High expression levels of Nectin-4 in tumors is associated with poor prognosis for patients. Nectin-4 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.

BAT8007 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 BAT8007 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. BAT8007 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies.