Onconic Therapeutics' Nesuparib Receives IND Approval for Phase 2 Ovarian Cancer Trial

Stepwise Validation of Pan-Cancer Expansion
Including Pancreatic and Endometrial Cancer Indications

Onconic Therapeutics announced on January 20 that the Ministry of Food and Drug Safety has approved the Phase 2 clinical trial plan (IND) for Nesuparib, its next-generation dual-targeted anticancer drug candidate, for the treatment of ovarian cancer.

Onconic Therapeutics Research Laboratory Facility. Onconic Therapeutics

This clinical trial will enroll approximately 87 patients with ovarian cancer who have relapsed or developed resistance after previous PARP inhibitor therapy. The study aims to clinically validate the concept of "re-maintenance therapy," which targets the treatment gap following existing maintenance therapy. Patient enrollment and dosing will take place at major tertiary hospitals in Korea, including Severance Hospital.

Under a joint research and development agreement with Celltrion, Onconic Therapeutics will evaluate the safety, tolerability, and antitumor efficacy of the combination therapy of Nesuparib and Begzelma, an anti-angiogenic agent.

Nesuparib is a dual-mechanism anticancer drug candidate that simultaneously inhibits both "PARP" and "Tankyrase," which are enzyme proteins that function inside cells. The goal is to reduce the development of resistance, a problem associated with existing PARP inhibitor therapies.

Nesuparib has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for pancreatic cancer and gastric cancer indications. It is currently in Phase 2 clinical trials for four indications: pancreatic cancer, endometrial cancer, ovarian cancer, and gastric cancer.