Onconic Therapeutics Receives Approval for Phase 1b Clinical Trial of Pancreatic Cancer Drug Candidate

Onconic Therapeutics CI (Photo by Onconic Therapeutics)

[Asia Economy Reporter Chunhee Lee] Onconic Therapeutics' pancreatic cancer drug candidate 'JPI-547' has received approval for clinical Phase 1b from the Ministry of Food and Drug Safety.

Onconic Therapeutics announced on the 4th that the clinical Phase 1 trial plan for its PARP/Tankyrase dual-inhibitor targeted anticancer drug JPI-547 has been approved by the Ministry of Food and Drug Safety. This clinical trial is scheduled to be conducted at Seoul National University Hospital and will evaluate safety and tolerability in patients with locally advanced/metastatic pancreatic cancer.

JPI-547 was designated as an orphan drug (ODD) by the U.S. Food and Drug Administration (FDA) in March last year, followed by designation as a development-stage orphan drug by the Ministry of Food and Drug Safety in June. In the same month, at the American Society of Clinical Oncology (ASCO), Phase 1 clinical trial results targeting multiple cancer types including ovarian and breast cancer were disclosed, drawing industry attention.

JPI-547 is a novel drug candidate that simultaneously inhibits PARP and tankyrase as a dual-inhibitor targeted anticancer agent. PARP is an enzyme that repairs cellular DNA damage, including cancer cell DNA, so inhibiting PARP is necessary to induce cancer cell death. Tankyrase is an enzyme essential for cancer cell formation. JPI-547 has a dual-inhibitory mechanism that simultaneously suppresses both enzymes to induce cancer cell death, making it a promising next-generation drug candidate.

An Onconic Therapeutics representative stated, “We plan to promptly advance the Phase 1b clinical trial to ensure that JPI-547 is recognized as an innovative drug,” adding, “We also intend to continue clinical trials for various cancer types with high unmet needs beyond pancreatic cancer.”

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