FDA has granted Mabwell Orphan Drug Designation (ODD) for their investigational Nectin-4-targeting antibody-drug conjugate (ADC), 9MW2821, for treating esophageal cancer.
This designation recognized unmet medical needs for esophageal cancer, offering benefits to 9MW2821 drug developers such as assistance with medication development, tax credits for clinical trials, and potential market exclusivity after approval.
This action follows the FDA’s previous Fast Track Designation (FTD) for 9MW2821, which aimed to expedite developing and reviewing this ADC for esophageal squamous cell carcinoma.
Significantly, 9MW2821 is the first therapeutic drug candidate targeting Nectin-4 developed by a Chinese company to enter clinical trials and demonstrate clinical benefit.
While esophageal cancer was the current focus, 9MW2821 also holds promise for cervical cancer, making it the first ADC targeting Nectin-4 to reveal clinical data for both these indications.
In addition to the esophageal cancer program, Mabwell is conducting clinical studies in China to evaluate 9MW2821 for treating a broader range of advanced solid tumors.
Furthermore, a phase III clinical study for 9MW2821 monotherapy in urothelial carcinoma patients, who had received standard treatments, was underway while a phase I/II study assessing 9MW2821 in combination with PD-1 inhibitors completed enrollment of its first patient.
Source: FDA Grants Orphan Drug Designation to 9MW2821
https://www.mabwell.com/en/news_info/id-146.html
