Onconic Therapeutics is advancing its cancer drug candidate, Nesuparib, into Phase 2 clinical trials for ovarian cancer, following successful studies in pancreatic and endometrial cancers.
The company announced on Tuesday that it received approval from the Ministry of Food and Drug Safety for its Investigational New Drug (IND) application to test Nesuparib in ovarian cancer patients.
Onconic is now gearing up to enroll patients and begin dosing at leading medical centers across the country, including Severance Hospital. This trial aims to establish a groundbreaking re-maintenance therapy approach, which is not currently part of standard treatment guidelines for ovarian cancer.
The study seeks to validate this novel re-maintenance strategy following conventional PARP inhibitor maintenance treatments, potentially offering a new lifeline for patients with recurrent ovarian cancer.
Designed to include about 87 participants, the Phase 2 trial will focus on ovarian cancer patients who have either relapsed or developed resistance after treatment with first-generation PARP inhibitors.
Under a collaboration agreement inked last June with biotech giant Celltrion, Onconic plans to evaluate the safety, tolerability, and anti-tumor efficacy of combining Nesuparib with Celltrion’s anti-angiogenesis drug, Vegzelma.
Nesuparib stands out as a first-in-class dual-target cancer drug candidate, simultaneously inhibiting PARP and Tankyrase. This innovative approach tackles resistance issues plaguing existing synthetic lethality-based therapies and addresses limitations of current treatments, such as changes in the tumor microenvironment and activation of the Wnt/β-catenin pathway.
The drug’s ability to modulate Wnt signaling through Tankyrase inhibition offers a potential solution to the resistance and treatment durability challenges that have stumped PARP monotherapy, positioning Nesuparib as a uniquely competitive option for hard-to-treat solid tumors.
Nesuparib has already caught the U.S. Food and Drug Administration’s (FDA) attention, receiving Orphan Drug Designation for both pancreatic and gastric cancer indications in 2021 and 2025, respectively.
Accelerating next-generation synthetic lethality dual-target anticancer drug development
The company has secured significant regulatory advantages, including Fast Track eligibility and potential Accelerated Approval based on Phase 2 results, as well as exemption from new drug application review fees.
With this latest milestone in ovarian cancer, Onconic aims to demonstrate Nesuparib’s broad applicability across major cancer types and accelerate its global approval strategy.
Currently, Nesuparib is undergoing Phase 2 trials for four indications, including pancreatic, endometrial, and ovarian cancers, as well as a recently approved Phase 1b/2 trial in gastric cancer.
This progress signifies Nesuparib’s transition beyond initial safety evaluations, entering a critical phase where it can simultaneously prove its clinical potential as a pan-tumor treatment for multiple challenging solid tumors that Target.
The company expects this development to strengthen its position in future global approval strategies and partnership negotiations.
Onconic is committed to accelerating clinical progress across multiple indications, aiming to establish Nesuparib as a next-generation cornerstone in cancer treatment.
An Onconic spokesperson stated that this Phase 2 IND approval marks Nesuparib’s transition from a promising candidate to a rigorously tested potential therapy. They’re now entering a crucial validation phase, putting Nesuparib to the test in real-world patient scenarios. Backed by its strong financial position and extensive late-stage clinical experience, it is poised to ramp up the multi-indication trials and position Nesuparib as a game-changing option in the global fight against cancer.
