FDA Grants Orphan Drug Status to 7MW3711
Wednesday, July 17, 2024
Mabwell (688062.SH), an innovative biopharmaceutical company with a comprehensive industry chain, recently announced that its self-developed novel ADC targeting B7-H3 (R&D code: 7MW3711) has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer.
Orphan Drug Designation by the FDA is granted to treatments for rare diseases affecting fewer than 200,000 patients in the United States. This designation provides several benefits to drug developers, including assistance with drug development, tax credits for a portion of clinical trial expenses, and seven years of market exclusivity post-approval.
7MW3711, developed using Mabwell's IDDC™ platform, is an innovative ADC comprising a unique antibody molecule, novel linker (IDconnect™), and a novel payload (Mtoxin™). Upon entering the body, 7MW3711 specifically targets antigens on tumor cell membranes, internalizes, and traffics to lysosomes, where it releases a cytotoxic drug, inducing tumor cell apoptosis.
Pharmaceutically, 7MW3711 is characterized by its stable structure, homogeneous composition, high purity, and suitability for industrial scale-up. Compared to other ADCs in its class globally, 7MW3711 has demonstrated superior tumor-killing effects in various animal tumor models. Safety evaluations in animal models, including cynomolgus monkeys, have effectively managed both on-target and off-target toxicities, highlighting its favorable safety profile and pharmacokinetic properties. These findings underscore 7MW3711's clinical differentiation and promising prospects for further development.
Mabwell's IDDC™ platform represents a next-generation ADC technology, incorporating proprietary core technologies such as DARfinity™ for site-specific conjugation, IDconnect™ for precise linking, Mtoxin™ for novel payload delivery, and LysOnly™ for conditional release structures. ADCs developed using these technologies exhibit enhanced structural uniformity, stability, efficacy, and tolerability. The novel payload Mtoxin™ (MF6) has demonstrated strong pharmacodynamic properties, bystander killing efficacy, and efficacy against multidrug resistance.
Multiple drug candidates utilizing the IDDC™ platform are currently in various stages of clinical development at Mabwell. Notably, the novel Nectin-4-targeting ADC, 9MW2821, is in Phase III trials for urothelial carcinoma, while 7MW3711 and the Trop-2-targeting ADC, 9MW2921, are progressing through clinical trial stages.
Source: prnewswire.com
