AIM ImmunoTech Plans Phase 3 Pancreatic Cancer Trial After Over 100-Patient Phase 2 Success
AIM ImmunoTech is planning a Phase 3 Ampligen trial in pancreatic ductal adenocarcinoma under a Thermo Fisher PPD agreement, building on Phase 2 DURIPANC data showing improved progression-free and overall survival in over 100 patients. The company holds US and EU Orphan Drug status and a Japanese patent expiring 2039.
1. Phase 3 Trial Planning
AIM ImmunoTech has engaged Thermo Fisher’s PPD to design a pivotal Phase 3 Ampligen trial in pancreatic ductal adenocarcinoma, marking the transition to late-stage development. This collaboration aims to optimize study protocols and accelerate regulatory submissions for Ampligen’s monotherapy and combination regimens.
2. Clinical Data Highlights
Encouraging signals from the Phase 2 DURIPANC study, which tests Ampligen with AstraZeneca’s durvalumab, have shown improvements in progression-free and overall survival across more than 100 treated patients, alongside a favorable safety profile. Additional positive outcomes emerged from an 82-patient Named Patient Program monotherapy dataset demonstrating significant survival gains versus historical controls.
3. IP and Orphan Drug Status
AIM holds Orphan Drug Designations for pancreatic cancer in the US and EU, and has applied for the same in Japan. Its global IP estate includes US, European and Japanese patents—expiring in 2039—that cover Ampligen combinations with checkpoint inhibitors across multiple oncology indications.
4. Upcoming Milestones
Key near-term value drivers include completion of Phase 2 DURIPANC enrollment and data updates, progress on Japanese Orphan Drug designation, and submission of an IND to initiate the planned Phase 3 study. These milestones are expected to support long-term value creation.