Onconic Targeted Anticancer Drug 'JPI-547' Designated as a Rare Drug by MFDS

[Asia Economy Reporter Chunhee Lee] Onconic Therapeutics' targeted anticancer drug under development has been designated as an orphan drug in the development stage.

Onconic, a new drug development subsidiary of Jeil Pharmaceutical, announced on the 2nd that its pancreatic cancer drug candidate 'JPI-547' has been designated as an orphan drug in the development stage by the Ministry of Food and Drug Safety (MFDS) for "BRCA mutation or HRD-positive unresectable advanced or metastatic pancreatic cancer." Earlier in March, JPI-547 was also designated as an orphan drug for pancreatic cancer treatment by the U.S. Food and Drug Administration (FDA).

JPI-547 is a dual-inhibitor targeted anticancer drug that simultaneously inhibits PARP (poly ADP-ribose polymerase) and Tankyrase. PARP is an enzyme that repairs DNA damage in cells, including cancer cell DNA, so inhibiting PARP induces cancer cell death. Tankyrase is an enzyme essential for cancer cell formation. The dual-inhibition mechanism of simultaneously suppressing these two enzymes to kill cancer cells is the characteristic of JPI-547.

The results of the Phase 1 clinical trial of JPI-547 will be disclosed at the annual meeting of the American Society of Clinical Oncology (ASCO), held online on the 4th. The full clinical results, including anticancer efficacy and safety data of JPI-547, will be revealed for the first time. Subsequently, based on the Phase 1 results, Onconic plans to initiate follow-up clinical trials in Korea and the U.S. targeting ovarian cancer and pancreatic cancer indications.

Jung-Hoon Kim, CEO of Onconic, said, "With JPI-547 being designated as an orphan drug in the development stage by the MFDS following the U.S. FDA, its potential in the pancreatic cancer field, where treatment options have been limited, has been recognized. We will do our best in follow-up research and clinical trials to help patients suffering from pancreatic cancer."

This content was produced with the assistance of AI translation services.