Hope for Improved Survival Rates in Patients with Metastatic and Advanced Pancreatic Cancer
Onconic Therapeutics announced on September 29 that it has received approval from the Ministry of Food and Drug Safety for a Phase 2 clinical trial plan (IND) for "Nesuparib," a next-generation synthetic lethal dual-target anticancer drug candidate, targeting locally advanced and metastatic pancreatic cancer.
The Phase 2 clinical trial aims to verify the antitumor efficacy and safety of Nesuparib in combination with standard therapy as a first-line treatment, based on the safety, tolerability, and antitumor effects confirmed in the Phase 1b trial.
Nesuparib is a "first-in-class" dual-target synthetic lethal anticancer drug candidate that simultaneously inhibits PARP (an enzyme involved in DNA damage repair in cancer cells) and Tankyrase (an enzyme that affects cancer growth and progression).
Onconic Therapeutics has begun preparations for patient recruitment and administration, aiming to quickly establish scientific evidence for Nesuparib as a next-generation treatment option for locally advanced and metastatic pancreatic cancer, which remains a significant area of unmet medical need worldwide, and to demonstrate its value as an anticancer drug.
Nesuparib was designated as an orphan drug (ODD) for pancreatic cancer by the U.S. Food and Drug Administration (FDA) in 2021, and it has also been designated as a developmental-stage orphan drug for pancreatic cancer by the Ministry of Food and Drug Safety in Korea. In May of this year, the U.S. FDA additionally granted ODD status for gastric cancer and gastroesophageal junction cancer. Nesuparib is currently being developed as a pan-tumor therapy to address unmet medical needs across various types of cancer.
According to the National Cancer Information Center, the five-year survival rate for pancreatic cancer in Korea is only 16.5%, and for patients with distant metastasis, the five-year survival rate drops to as low as 1-3%. Market research firm Fortune Business Insights forecasts that the global pancreatic cancer therapeutics market will grow from approximately $2.9 billion in 2023 to about $10.7 billion in 2032, representing a compound annual growth rate of 15.8%.
With this entry into Phase 2 clinical trials for pancreatic cancer, Onconic Therapeutics has now initiated its second Phase 2 trial, following the ongoing investigator-initiated Phase 2 study of endometrial cancer in combination with Keytruda.
A representative from Onconic Therapeutics emphasized, "This approval is highly significant as it marks a key milestone for Nesuparib, moving beyond being a mere candidate to entering the full-scale efficacy validation stage. The successful development of Nesuparib will not only provide new treatment options for patients but also serve as a crucial turning point in enhancing our technological value and in strategic partnership and licensing-out (L/O) negotiations with global pharmaceutical companies."
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