On April 25, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, reported that the Phase I/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 for multiple advanced solid tumors will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which will be held in Chicago, USA, from May 31-June 4, 2024 (Press release, Mabwell Biotech, APR 25, 2024, View Source;mabwell-to-present-clinical-data-of-9mw2821-in-multiple-advanced-solid-tumor-302127436.html [SID1234642363]).
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Oral Presentation
Abstract Title: 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study.
Session Date and Time: 6/3/2024; 8:00 AM-9:30 AM CDT
Presenter: Prof. Zhang Jian Chief Physician/Doctoral Supervisor (Fudan University Shanghai Cancer Center)
Abstract Number for Publication: 3013
About 9MW2821
9MW2821 is the first site-specific conjugated novel ADC targeting Nectin-4 developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. Multiple clinical studies of 9MW2821 have been conducted in China to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of 9MW2821 in patients with various advanced solid tumors.
The phase III clinical study of 9MW2821 monotherapy has officially been initiated in patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The phase I/II clinical study of 9MW2821 in combination with PD-1 inhibitors is also ongoing, with the first patient already enrolled. 9MW2821 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in February 2024 for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Currently, 9MW2821 is the first therapeutic drug candidate targeting Nectin-4 in the world to disclose clinical efficacy and safety data for indications of cervical cancer and esophageal carcinoma.