Onconic and Celltrion team on phase 2 re-maintenance study in ovarian cancer

Onconic Therapeutics has submitted an investigational new drug (IND) application to Korea’s Ministry of Food and Drug Safety (MFDS) to run a phase 2 study combining its experimental pill nesuparib with Celltrion’s Vegzelma, a bevacizumab biosimilar to Roche and Genentech’s Avastin, in women with ovarian cancer previously treated with a PARP inhibitor.

The trial is designed for re-maintenance therapy -- a second course of maintenance treatment after prior PARP-inhibitor maintenance -- where platinum chemotherapy is often the remaining option. Investigators plan to evaluate safety, tolerability and antitumor activity of the combination.

Nesuparib blocks PARP, an enzyme that helps repair DNA damage, and tankyrase, part of the WNT signaling pathway involved in tumor growth, with the goal of selectively killing cancer cells dependent on those pathways. 

Onconic said it is also running or preparing studies in pancreatic, gastric and endometrial cancers, and recently received MFDS clearance to advance nesuparib into a phase 2 first-line trial in advanced or metastatic pancreatic cancer.