Mabwell (688062.SH) has initiated a Phase III clinical study of 9MW2821, its proprietary Nectin-4-targeting antibody-drug-conjugate (ADC), for patients with locally advanced or metastatic triple-negative breast cancer.
The company announced that 9MW2821 is the world's first Nectin-4 ADC to enter Phase III development for this difficult-to-treat cancer.
Metastatic triple-negative breast cancer (TNBC) is one of the most aggressive forms of breast cancer, lacking estrogen, progesterone, and HER2 receptors- which means patients have fewer targeted treatment options. It accounts for 15-20% of global breast cancer cases and is more commonly diagnosed in younger women. Standard therapies often rely on chemotherapy or topoisomerase inhibitor-based ADCs, but many patients eventually progress, leaving a significant unmet medical need.
The newly launched Phase III trial is a randomized, open-label, controlled, multicentre study comparing 9MW2821 with the investigator's choice of chemotherapy in patients who have previously received taxane-based therapy, with or without immunotherapy, and an ADC containing a topoisomerase inhibitor payload. The goal is to evaluate whether 9MW2821 can improve outcomes in patients who have exhausted current standard options.
9MW2821 has already shown encouraging activity in earlier studies and has received Fast Track Designation from the U.S. FDA for Nectin-4-positive TNBC, underscoring its potential to address a high-need patient population. The therapy is also being evaluated across multiple tumor types, including urothelial carcinoma and cervical cancer, where additional pivotal trials are underway.
With the Phase III initiation, Mabwell moves closer to determining whether 9MW2821 can become a new treatment option for patients with advanced TNBC- a group for whom therapeutic progress has historically been limited.
Mabwell has traded between $16.78 and $63.59 over the past year. The stock closed Wednesday's trading at $38.10, up 5.44%.
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