Bio-Thera Solutions, Ltd., a commercial-stage pharmaceutical company, 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 tumours aims to evaluate the safety and tolerability of BAT8007. 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 tumours.
BAT8007 is an antibody-drug conjugate (ADC) targeting Nectin-4 designed for the treatment of solid tumours. 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 foetal tissues, while those expression levels decline in adulthood and has limited distribution in healthy tissues.
Nectin-4 is overexpressed in a variety of solid tumours, 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 tumours is associated with poor prognosis for patients. Nectin-4 is a validated drug target with one approved drug for the treatment of solid tumours and is a target of high interest for new drug discovery.
BAT8007 was developed by using Bio-Thera
