16 July 2024: FDA Grants Orphan Drug Designation to 7MW3711
Mabwell announced that its novel B7-H3-targeting ADC, 7MW3711 received an Orphan Drug Designation from the U.S. FDA for treating Small-Cell Lung Cancer
7MW3711 is developed using Mabwell’s IDDC™ platform and consists of a unique antibody molecule, a novel linker, and the payload Mtoxin™ (TOP1i). It targets tumor cell membranes, gets internalized, and releases a cytotoxic drug to induce apoptosis in tumor cells
In animal models, 7MW3711 demonstrated superior tumor-killing effects compared to other ADCs. Safety evaluations in cynomolgus monkeys showed effective control of on-target and off-target toxicities, indicating a favorable safety profile and pharmacokinetic properties
Research results suggest that 7MW3711 possesses clinical differentiation characteristics, indicating a promising future for its development
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