LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE: GSK), has been awarded the Breakthrough Therapy Designation (BTD) by the US FDA for their jointly developed antibody-drug conjugate (ADC) HS-20093, also known as GSK5764227. The therapy is intended for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) whose disease has progressed following platinum-based chemotherapy, indicating a relapsed or refractory state.
GSK57644227/HS-20093 is an innovative B7-H3-targeted ADC that pairs a fully humanized anti-B7-H3 monoclonal antibody with a topoisomerase inhibitor (TOPOi) payload. The two companies entered into a licensing agreement in December 2023, with GSK securing exclusive global rights to the drug, excluding the Chinese mainland, Hong Kong, Macau, and Taiwan. The upfront payment for the licensing deal was USD 185 million, with potential future milestone payments amounting to USD 1.525 billion.
The BTD designation from the FDA comes on the heels of promising data from the ongoing ARTEMIS-001 Phase I clinical trial, an open-label, multi-centre study involving over 200 patients. The trial is designed to evaluate the safety, tolerability, and preliminary anti-tumour activity of the ADC in patients with locally advanced or metastatic solid tumors, including those with relapsed or refractory ES-SCLC. The study is being conducted by Hansoh and the results are expected to be presented at the 2024 World Conference on Lung Cancer, scheduled from September 7 to 10 in San Diego, California, USA.- Flcube.com
