Onconic Therapeutics Submits IND Application for Phase 2 Trial of Anticancer Drug 'Nesuparib' in Collaboration with Celltrion

Combination with Europe’s Top-Prescribed Bevacizumab-Based Anticancer Therapy

Onconic Therapeutics has initiated a clinical trial for a combination therapy that could change the global paradigm for ovarian cancer treatment.

On October 1, Onconic Therapeutics announced that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase 2 clinical trial in Korea. The trial will evaluate a combination therapy of its next-generation dual-inhibitor synthetic lethality anticancer drug candidate, Nesuparib, and Celltrion’s anticancer biosimilar, Vegzelma® (active ingredient: bevacizumab).

This Phase 2 clinical trial is significant in that it aims to address the high unmet medical needs in the field of ovarian cancer by creating a new therapeutic opportunity-re-maintenance therapy-through the combination of Nesuparib and Vegzelma. This is particularly important in situations where platinum-based therapy is the last line of treatment after the use of PARP inhibitor monotherapy, which is the current standard maintenance therapy for ovarian cancer.

Through this Phase 2 trial, Onconic Therapeutics will focus on comprehensively verifying the safety, tolerability, and antitumor efficacy of the new re-maintenance combination therapy of Nesuparib and Celltrion’s Vegzelma®.

Nesuparib is a next-generation synthetic lethality anticancer drug candidate with a differentiated dual-inhibition mechanism. It simultaneously inhibits PARP (Poly ADP-ribose polymerase), which is responsible for the repair of DNA damage in cancer cells, and tankyrase, which is involved in cancer growth and proliferation.

Currently, Onconic Therapeutics is conducting or preparing clinical trials targeting solid tumor indications with limited existing treatment options, such as pancreatic cancer, gastric cancer, endometrial cancer, and ovarian cancer. Notably, the company recently received approval from the Ministry of Food and Drug Safety to proceed to Phase 2 clinical trials for first-line treatment of advanced/metastatic pancreatic cancer based on the safety and antitumor efficacy data from Phase 1b. This has heightened expectations for the emergence of a new first-line therapy for pancreatic cancer.

Celltrion’s Vegzelma® is an antibody biosimilar that inhibits tumor angiogenesis by blocking vascular endothelial growth factor (VEGF) signaling. It is the top-prescribed bevacizumab-based therapy in Europe and has received approval from major global regulatory agencies. This combination clinical trial is expected to maximize the synergy between the two pipelines and create a new field of re-maintenance therapy after PARP inhibitor use in ovarian cancer, presenting a next-generation therapeutic paradigm.

An official from Onconic Therapeutics stated, "With this IND application, Nesuparib, through strategic collaboration with Vegzelma, will create new value as an innovative anticancer drug in the global ovarian cancer market. We will strive to provide tangible survival benefits to patients with refractory cancers."

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