Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK counterpart GSK plc (NYSE: GSK) have jointly announced that they have received the prestigious Breakthrough Therapy Designation (BTD) from the US FDA for their candidate HS-20093, also known as GSK5764227. This B7-H3-targeted antibody-drug conjugate (ADC) is being developed for the treatment of extensive-stage small-cell lung cancer (ES-SCLC) in patients with disease progression following platinum-based chemotherapy, characterized as relapsed or refractory.
GSK5764227/HS-20093 represents an innovative investigational ADC that targets B7-H3, consisting of a fully humanized anti-B7-H3 monoclonal antibody linked to a topoisomerase inhibitor (TOPOi) payload. In a strategic licensing agreement signed in December 2023, GSK acquired global exclusive rights to the drug, excluding mainland China, Hong Kong, Macau, and Taiwan, for an upfront payment of USD 185 million and potential future milestone payments totaling USD 1.525 billion.
The BTD was granted based on compelling data from the ongoing ARTEMIS-001 Phase I clinical trial, an open-label, multi-center study involving over 200 patients. The trial, led by Hansoh, is assessing the safety, tolerability, and preliminary anti-tumor activity of GSK5764227/HS-20093 in patients with locally advanced or metastatic solid tumors, including those with relapsed or refractory ES-SCLC. The findings from this trial are scheduled to be presented at the 2024 World Conference on Lung Cancer, to be held from September 7-10 in San Diego, California, USA.- Flcube.com
