Antengene Announces ATG-101 Granted Orphan Drug Designation by the U.S. FDA

Key Facts

HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S.
Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases (a condition with a prevalence of less than 200,000 in the U.S.), and to provide incentives to the subsequent development, registration and commercialization to designated drugs.
ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile.
Dr. Bo Shan, Antengene's Chief Scientific Officer, said, "We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer.