Idience, an oncology drug development subsidiary of Ildong Pharmaceutical Group, announced Wednesday that its targeted anticancer drug candidate benadaparib has received Fast Track designation from the U.S. Food and Drug Administration.
Fast Track is an FDA expedited review program designed to accelerate the development of new drugs for serious conditions. Benadaparib is a next-generation inhibitor that selectively targets PARP1, an enzyme that repairs DNA damage in cancer cells, thereby suppressing tumor growth. The drug previously received FDA Orphan Drug designation for gastric cancer in 2022.
Idience is currently conducting Phase 1b/2a clinical trials in South Korea and the United States, testing benadaparib in combination with irinotecan, an existing chemotherapy agent, for gastric cancer patients. The trials aim to establish optimal dosing, safety, and efficacy data.
"This designation recognizes benadaparib's clinical potential and its ability to address unmet medical needs," said Lee Won-sik, CEO of Idience.
