Onco-Summaries: Daily Oncology Updates at a Glance

07/01/2026

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• Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer 

• Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer

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Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer (Ref)

The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer.

• Dr Linda Wu, CDO, Arbele: "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. This designation reinforces our confidence in the therapeutic potential of ARB1002 and supports its continued advancement through clinical development."

• Dr Tony Wong, CTO, Arbele: "This designation highlights CDH17 as a promising target in pancreatic cancer and validates Arbele's ADC development strategy. We look forward to continued engagement with the FDA as we progress ARB1002."

• 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.

Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer (Ref)

The US FDA and the EMA granted the orphan drug designation to Curadel Pharma's CPI-008 (cRGD-ZW800-1; integrin-targeted, zwitterionic imaging drug) for margin detection of pancreatic cancer during surgery.

• John V. Frangioni, MD, PhD, Founder and CEO, Curadel: “Receiving orphan designation from both the FDA and the EMA is a profoundly important milestone for Curadel, granting us valuable incentives to fuel our development efforts. As a pioneering company working to introduce significant advances in surgical imaging, the efficiencies of fee exemptions, credits, along with the potential for market exclusivity are vital tools to help us smartly deploy our resources and focus on delivering value to the surgical community.”

• CPI-008 has demonstrated strong imaging capabilities in investigator-initiated Phase 2 studies in multiple cancers including pancreatic cancer, head and neck cancer, and colorectal cancer.