The investigational therapy, targeting the B7-H3 antigen, has shown promising tumor-killing effects and a good safety profile in preclinical models.
RT’s Three Key Takeaways:
- FDA Orphan Drug Designation: Mabwell’s 7MW3711 has received Orphan Drug Designation from the FDA for the treatment of small cell lung cancer.
- Innovative ADC Technology: 7MW3711, developed through Mabwell’s IDDC platform, targets the B7-H3 antigen on tumor cells and has demonstrated tumor-killing effects in multiple animal models.
- Safety and Efficacy: Preclinical studies, including those involving cynomolgus monkeys, have shown that 7MW3711 has a favorable safety profile with controlled on-target and off-target toxicities.
Shanghai-based biopharmaceutical company Mabwell announced that its antibody-drug conjugate 7MW3711 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer.
The FDA grants Orphan Drug Designation to treatments for rare diseases in the United States that affect fewer than 200,000 patients. Orphan Drug Designation offers policy benefits to drug developers, including as aid with medication development, tax credits for a part of clinical trial expenditures, and seven years of market exclusivity upon approval.
7MW3711, developed through Mabwell’s IDDC platform, targets the B7-H3 antigen on tumor cells. It is composed of an antibody molecule, a novel linker, and a novel payload, Mtoxin. When 7MW3711 enters the human body, it binds to antigens on the tumor cell membrane surface, is internalized and trafficked to the lysosome, releases a cytotoxic drug, and induces the apoptosis of tumor cells.
Early Results in Animal Models
7MW3711 is a pharmaceutical characterized by stable structure, homogeneous composition, high purity, and is suitable for industrial scale-up. Compared with antibody-drug conjugates in the same class at home and abroad, 7MW3711 has shown better tumor-killing effects in multiple animal tumor models, according to a release from the company.
In a safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 were effectively controlled, showing a good safety profile and pharmacokinetic properties. “The research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development,” according to a release from the company.
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