China-based biotech Antengene Corp., Ltd (HKG: 6996) has announced that its pipeline candidate ATG-101, a PD-L1/4-1BB bispecific antibody (BsAb), has been awarded orphan drug designation (ODD) status from the US FDA for its use in treating pancreatic cancer. This designation is expected to facilitate greater communication with the FDA and potentially accelerate the approval timeline, according to Antengene.
Pancreatic Cancer and Orphan Disease Status
Pancreatic cancer is classified as an orphan disease due to its prevalence falling below the 200,000 annual cases stipulated in the US for orphan drug designation. Despite this classification, pancreatic cancer is a relatively common rare disease, with over 55,000 new cases and 44,330 related deaths reported in 2018. Projections indicate that pancreatic cancer incidence will rise, making it the second most common form of cancer by 2030.
ATG-101 Mechanism and Clinical Trials
ATG-101’s dual action blocks the binding of the immunosuppressive PD-1/PD-L1 pathway and conditionally induces 4-1BB stimulation, thereby activating anti-tumor immune effectors and delivering enhanced anti-tumor activity with an improved safety profile. Phase I clinical trial approvals have been obtained in Australia, the US, and China to assess the molecule in treating a range of solid tumors and B-cell non-Hodgkin’s lymphoma.
Future Outlook
The orphan drug designation for ATG-101 underscores Antengene’s commitment to addressing significant unmet needs in pancreatic cancer treatment. With its innovative mechanism and ongoing clinical trials, ATG-101 is poised to contribute to improved patient outcomes in this challenging disease area.-Fineline Info & Tech
