Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical specializing in novel drug development, said its next-generation dual-target synthetic lethal anticancer drug candidate, Nesuparib, has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of gastric cancer, including gastroesophageal junction cancer.
Onconic Therapeutics’ nesuparib secures FDA Orphan Drug Designation for gastric cancer, highlighting its potential as a next-generation dual-target anticancer therapy.
Onconic Therapeutics’ nesuparib secures FDA Orphan Drug Designation for gastric cancer, highlighting its potential as a next-generation dual-target anticancer therapy.
This marks the second time Nesuparib has received an ODD, following its designation as an orphan drug for pancreatic cancer by both the FDA and the Ministry of Food and Drug Safety (MFDS) in 2021.
Receiving an ODD from the FDA provides several benefits for drug development, including fast-track review, accelerated approval pathways, exemption from certain regulatory fees, access to research and development grants, and extended market exclusivity. These incentives facilitate the faster development and commercialization of promising therapies for rare diseases.
“The fact that the same drug candidate has been designated as an orphan drug for two different cancer types demonstrates the superior technology and development potential of nesuparib as an anticancer treatment,” an Onconic Therapeutics official said. “We are committed to advancing our research and development efforts to offer new treatment options for gastric cancer patients with limited therapeutic choices.”
Nesuparib is a next-generation targeted anticancer agent designed to inhibit both Poly ADP-ribose polymerase (PARP) and tankyrase. PARP is an enzyme that repairs DNA damage, including that of cancer cells, thereby promoting their survival.
Inhibiting PARP can lead to the destruction of cancer cells. tankyrase, on the other hand, regulates the Wnt/β-catenin signaling pathway, which plays a crucial role in cancer cell growth and metastasis.
Blocking Tankyrase is expected to effectively suppress cancer cell proliferation. Onconic Therapeutics anticipates that this dual-inhibition mechanism will enhance the anticancer efficacy of nesuparib compared to existing PARP inhibitors and enable its use in indications where conventional PARP inhibitors have shown limited effectiveness.
Onconic is currently conducting a phase 1b/2 clinical trial of nesuparib for pancreatic cancer and a phase 2 investigator-initiated trial in combination with Keytruda for endometrial cancer. The company also plans to present its research findings on nesuparib at the American Association for Cancer Research (AACR) 2025 annual meeting in April.
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Lee Han-soo corea022@docdocdoc.co.kr
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