FDA Grants Orphan Drug Designation to 7MW3711 for SCLC

The United States Food and Drug Administration (FDA) has granted orphan drug designation to the antibody-drug conjugate (ADC) 7MW3711 for the treatment of small cell lung cancer (SCLC), according to an announcement from Mabwell, the drug developer.

The novel B7-H3–targeting ADC is composed of an “innovative antibody molecule, novel linker, and novel payload Mtoxin (TOP1i),” according to Mabwell.

“Compared with ADCs in the same class at home and abroad, 7MW3711 has shown better tumor-killing effects in multiple animal tumor models,” company officials said in the announcement. “In the safety evaluation model of animals, including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties.”

Mabwell currently has several ADCs in clinical development stages that use the IDDC platform, which has “been validated in multiple drug candidates under development,” according to the company. These include the novel Nectin-4–targeting ADC 9MW2821, which is currently under evaluation for the indication of urothelial carcinoma in a phase 3 clinical trial. In addition, the novel B7-H3–targeting ADC 7MW3711 and Trop-2–targeting ADC 9MW2921 are both in clinical trial stages.

Source: PR Newswire