Seattle, January 7, 2026 — Arbele, a biotechnologycompany focused on developing innovative targeted cancer therapies, todayannounced that the U.S. Food and Drug Administration (FDA) has granted OrphanDrug 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 chemicallylinked to a potent cytotoxic agent. The ADC is designed to selectively bindCDH17, a cell-surface adhesion molecule overexpressed in pancreatic cancer,enabling targeted delivery of the cytotoxic payload to tumor cells whilelimiting off-target exposure.

“Orphan Drug Designation for ARB1002 marks a significant regulatorymilestone for Arbele and reflects the critical need for new treatment optionsfor patients with pancreatic cancer,” said Dr Linda Wu, Chief DevelopmentOfficer of Arbele. “This designation reinforces our confidence in thetherapeutic potential of ARB1002 and supports its continued advancement throughclinical development.”

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

ARB1002 is planned to enter a Phase 1 clinical trial this year, withArbele completing IND-enabling studies to support its clinical evaluation inpancreatic cancer.

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

About Arbele

Arbele is a clinical-stage biotechnology company developing potentialfirst-in-class and best-in-class immunotherapies for gastrointestinal cancersincluding colorectal, gastric and oesophageal cancers with high unmet medicalneeds. With a focus on CDH17-targeted T-cell engagers and antibody-drugconjugates, Arbele’s mission is to improve survival outcomes for patients withlimited treatment options. Learn more at www.arbelebio.com

For Press Contact, BD & Partnering Inquires

Dr. Diana Hay, diana.hay@arbelebio.com

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