Onconic Therapeutics announced on December 17 that it has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) of its next-generation synthetic lethal dual-target anticancer drug candidate, "Nesuparib," for a new indication in relapsed or metastatic gastric cancer.
This clinical trial aims to evaluate the safety, tolerability, and efficacy of Nesuparib in combination with the conventional chemotherapeutic agent irinotecan. The study will be conducted at major tertiary hospitals in Korea, targeting patients with relapsed or metastatic gastric cancer who have undergone at least third-line treatment and have limited therapeutic options.
This IND approval is considered a significant turning point in rigorously validating the clinical potential of Nesuparib in the field of advanced gastric cancer, where treatment alternatives are extremely limited. Building on this approval, the company will begin patient enrollment and dosing preparations, and plans to commence full-scale clinical trial operations.
According to "GLOBOCAN 2022," published last year by the International Agency for Research on Cancer (IARC) under the World Health Organization (WHO), gastric cancer sees 968,734 new cases and 660,175 deaths annually, ranking fifth in both incidence and mortality among 32 types of cancer worldwide. This figure is more than three times higher than ovarian cancer, which ranks 18th with approximately 320,000 new cases per year, highlighting that gastric cancer remains a disease with significant unmet medical needs globally.
"Nesuparib" is a first-in-class synthetic lethal dual-target anticancer drug candidate that simultaneously inhibits PARP and "Tankyrase," which is involved in regulating the Wnt signaling pathway. It is a core anticancer pipeline asset for Onconic Therapeutics.
This compound received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for pancreatic cancer in 2021. In March 2025, it additionally secured orphan drug designation for gastric cancer and gastroesophageal junction cancer, further recognizing its potential as a new treatment for gastric cancer.
Orphan drug designation in the United States is granted after the FDA reviews the scientific data for the compound. Upon approval, various economic incentives are provided, such as a waiver of the New Drug Application (NDA) review fee, which amounts to approximately 6.5 billion won, and seven years of market exclusivity post-approval. Notably, about 49% of new drugs approved by the FDA in 2022 received orphan drug designation, making this designation one of the key indicators of new drug development potential.
Currently, Nesuparib has begun patient dosing in a phase 2 clinical trial for pancreatic cancer and is also being studied in a phase 2 investigator-initiated trial for endometrial cancer in combination with the immuno-oncology drug Keytruda. By adding this new gastric cancer indication as a phase 2 pipeline, Onconic Therapeutics now has a total of three phase 2 clinical indications for anticancer therapies.
With the entry into clinical trials for gastric cancer, Onconic Therapeutics plans to expand its development strategy, previously focused on pancreatic and endometrial cancers, into the gastric cancer field, thereby accelerating the diversification of indications within its anticancer pipeline.
A representative from Onconic Therapeutics stated, "The IND approval for the phase 1b/2 trial in gastric cancer, along with the recent initiation of patient dosing in the phase 2 pancreatic cancer trial, marks a stage where the development value of Nesuparib as an anticancer drug is being fully validated. We will do our utmost to conduct the clinical trial to provide new treatment options for patients with advanced gastric cancer who have limited therapeutic alternatives."
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