Arbele Receives FDA Orphan Drug Designation for ARB1002, an Anti-CDH17 Antibody-Drug Conjugate for the Treatment of Pancreatic Cancer

SEATTLE, Jan. 7, 2026 /PRNewswire/ — Arbele, a biotechnology company focused on developing innovative targeted cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARB1002, its investigational antibody-drug conjugate (ADC) for the treatment of pancreatic cancer.

ARB1002 is composed of an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent. The ADC is designed to selectively bind CDH17, a cell-surface adhesion molecule overexpressed in pancreatic cancer, enabling targeted delivery of the cytotoxic payload to tumor cells while limiting off-target exposure.

“Orphan Drug Designation for ARB1002 marks a significant regulatory milestone for Arbele and reflects the critical need for new treatment options for patients with pancreatic cancer,” said Dr Linda Wu, Chief Development Officer of Arbele. “This designation reinforces our confidence in the therapeutic potential of ARB1002 and supports its continued advancement through clinical development.”

Pancreatic cancer is among the deadliest solid tumors, with limited effective therapies and poor long-term survival outcomes. The FDA’s Orphan Drug Designation program is intended to incentivize the development of therapies for rare diseases affecting fewer than 200,000 patients in the United States, offering benefits that may include tax credits for qualified clinical development expenses, exemption from certain FDA user fees, and seven years of market exclusivity following regulatory approval.

ARB1002 is planned to enter a Phase 1 clinical trial this year, with Arbele completing IND-enabling studies to support its clinical evaluation in pancreatic cancer.

“This designation highlights CDH17 as a promising target in pancreatic cancer and validates Arbele’s ADC development strategy,” added Dr Tony Wong, Chief Technology Officer. “We look forward to continued engagement with the FDA as we progress ARB1002.”

About Arbele

Arbele is a clinical-stage biotechnology company developing potential first-in-class and best-in-class immunotherapies for gastrointestinal cancers including colorectal, gastric and oesophageal cancers with high unmet medical needs. With a focus on CDH17-targeted T-cell engagers and antibody-drug conjugates, Arbele’s mission is to improve survival outcomes for patients with limited treatment options. Learn more at www.arbelebio.com

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SOURCE Arbele