Onconic Therapeutics has submitted a clinical trial plan to the Ministry of Food and Drug Safety to initiate Phase 2 clinical trials for Nesuparib, its dual-target anticancer drug candidate for advanced and metastatic pancreatic cancer. The company announced on December 18th that it will begin recruiting patients for the next phase of clinical development.
Addressing Critical Unmet Medical Need
Pancreatic cancer represents one of the most challenging malignancies in oncology, with limited treatment options and poor survival outcomes. In Korea, the 5-year survival rate stands at only 16.5%, while in the United States, it drops to just 9%. The disease is considered a representative incurable cancer due to difficulties in early diagnosis and the scarcity of effective therapeutic interventions.
Novel Dual-Target Mechanism
Nesuparib operates through a unique dual-target mechanism, simultaneously inhibiting both Tankyrase and poly ADP-ribose polymerase (PARP). This next-generation synthetic lethal anticancer approach targets PARP, which is involved in repairing DNA damage in cancer cells, and Tankyrase, which affects cancer growth and progression.
The drug's development addresses a critical limitation of existing PARP inhibitors, which are known to have a resistance incidence rate exceeding 50% within two years of treatment. Nesuparib has demonstrated therapeutic efficacy even when administered as monotherapy to solid cancers that have developed resistance to existing PARP inhibitors.
Regulatory Recognition and Market Positioning
Nesuparib has received significant regulatory recognition for its therapeutic potential. The U.S. Food and Drug Administration designated it as an orphan drug for pancreatic cancer in 2021, with the Korea Food and Drug Administration following suit. In March, the FDA extended orphan drug designation to include gastric cancer and gastroesophageal junction cancer.
The drug's international competitiveness has been acknowledged by industry analysts. A recent report by Delve Insight, a global market research firm, cited Nesuparib as a promising candidate alongside pipelines from major pharmaceutical companies including AstraZeneca and Merck.
Clinical Development Progress
The company has completed Phase 1b clinical trials in patients with advanced and metastatic pancreatic cancer, with results showing encouraging trends. An Onconic Therapeutics official stated, "We have confirmed an encouraging trend as a result of 1b clinical trials in patients with advanced and metastatic pancreatic cancer, and we plan to release related data at the Global Cancer Society."
Currently, Nesuparib is undergoing Phase 1b/2 clinical trials for pancreatic cancer and Phase 2 trials for endometrial cancer. The company is also conducting research and development to expand treatment indications through combination therapy approaches with established immunotherapies, including MSD's Keytruda and Celltrion's Begzelma, targeting various cancers such as ovarian cancer.
Intellectual Property Protection
Onconic Therapeutics has strengthened its intellectual property position by obtaining a patent for Nesuparib's use in Australia. The patent specifically covers the drug's therapeutic effect when administered as monotherapy to solid cancers resistant to existing PARP inhibitors. This family patent has been filed in 21 countries and registered in Australia, Eurasia, and South Africa, with patent protection extending until May 18, 2042.
Global Development Strategy
The company is preparing a comprehensive global clinical program utilizing the FDA's orphan drug system following the initiation of Phase 2 trials in Korea. An Onconic Therapeutics official emphasized their commitment to expanding Nesuparib's treatment indications through additional clinical development, aiming to provide new treatment options for unmet medical needs in the global anticancer drug market.
