JEIL PHARMACEUTICAL said on the 17th that its subsidiary Onconic Therapeutics received approval from the Ministery of Food and Drug Safety for an investigational new drug (IND) application for phase 1b–2 clinical trials of the next-generation anticancer drug candidate "Nesuparib" in patients with relapsed or metastatic gastric cancer.
The purpose of this trial is to evaluate the safety, tolerability, and efficacy of a combination therapy of Nesuparib and the conventional chemotherapeutic agent irinotecan. It is scheduled to be conducted at major tertiary hospitals in Korea, targeting patients with relapsed or metastatic gastric cancer who have undergone third-line treatment or more.
Nesuparib is a next-generation synthetic lethal anticancer drug candidate based on a dual-inhibition mechanism that simultaneously inhibits "PARP," which is responsible for DNA damage repair in cancer cells, and "Tankyrase," which is involved in cancer growth and proliferation.
Earlier, in 2021, Nesuparib received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for pancreatic cancer. Then, in Mar. 2025, it additionally obtained orphan drug designation for gastric cancer and gastroesophageal junction cancer, once again recognizing its development potential as a new treatment for gastric cancer.
In the United States, orphan drug designation is determined by the FDA after reviewing the scientific data of the substance, and when designated, various incentives are provided, including a waiver of the approximately 6.5 billion won new drug application (NDA) fee and seven years of market exclusivity after approval. In fact, about 49% of the new drugs approved by the FDA in 2022 had received orphan drug designation, and the industry views orphan designation as one indicator of the potential for new drug development.
Nesuparib has begun dosing patients in a phase 2 clinical trial for pancreatic cancer, and an investigator-initiated phase 2 trial in endometrial cancer in combination with Merck's immuno-oncology therapy "Keytruda" is also underway. With the addition of the gastric cancer indication as a new phase 2-stage pipeline, Onconic Therapeutics has secured a total of three phase 2 anticancer indications.
Onconic Therapeutics plans to use this entry into a gastric cancer trial as an opportunity to expand its development strategy, currently focused on pancreatic and endometrial cancers, into the gastric cancer field, accelerating the diversification of indications in its oncology pipeline.
An official at Onconic Therapeutics said, "The IND approval for phase 1b–2 in gastric cancer, in tandem with the recent start of patient dosing in the phase 2 pancreatic cancer trial, means that Nesuparib has entered a stage where its development value as an anticancer drug is being substantiated in earnest," adding, "We will do our utmost in conducting the trial to provide a new treatment option for patients with advanced gastric cancer who have limited treatment choices."