FDA has granted Orphan Drug Designation (ODD) to Mabwell (688062. SH), an innovation-driven biopharmaceutical company, for their novel B7-H3-targeting antibody-drug conjugate (ADC), 7MW3711, for treating small cell lung cancer (SCLC).
The ODD offered significant benefits to Mabwell and patients with SCLC, including aid in medication development, tax credits for clinical trials, and 7 years of market exclusivity upon approval if 7MW3711 is successful.
The FDA acknowledged 7MW3711’s promising preclinical data, offering hope to patients with SCLC.
This ADC, developed using Mabwell’s IDDC™ platform, demonstrated superior tumor-killing effects in animal models compared to existing drugs in the same class.
These findings emphasized the 7MW3711 potential and differentiation within the current SCLC treatment landscape, supporting its advancement to clinical trials.
Mabwell has several ADCs in development stages, including 7MW3711, which is now entering clinical trials for SCLC.
Additionally, Mabwell’s Nectin-4-targeting ADC, 9MW2821, is already in phase III trials for urothelial carcinoma, showcasing the potential of their IDDC™ platform.
Source: FDA Grants Orphan Drug Designation to 7MW3711
https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-7mw3711-302198021.html
