OCALA, Fla., June 24, 2026
AIM ImmunoTech Inc. highlighted significant progress across its pancreatic cancer development program, positioning Ampligen® (rintatolimod) for potential pivotal-stage clinical development. The company outlined multiple clinical, regulatory, intellectual property, and financial milestones achieved over recent months that strengthen its strategy to advance Ampligen as a novel immunotherapy for metastatic pancreatic cancer, one of the deadliest and most difficult-to-treat cancers.
Phase 2 DURIPANC Trial Reaches Key Clinical Milestones
Ampligen is currently being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca’s Imfinzi® (durvalumab) for metastatic pancreatic cancer. AIM announced that patient enrollment has been completed ahead of schedule, with the final participant successfully dosed. Interim clinical updates have continued to demonstrate encouraging safety findings, with no significant treatment-related toxicity reported. The study is being conducted in collaboration with AstraZeneca and Erasmus Medical Center, supporting the evaluation of Ampligen’s ability to stimulate innate immunity and potentially enhance checkpoint inhibitor activity.
Growing Clinical Evidence Supports Phase 3 Planning
The DURIPANC trial builds upon previous clinical experience, including a Dutch government-approved named patient program in which Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Alongside continued favorable safety data, AIM has expanded its global intellectual property portfolio covering Ampligen and checkpoint inhibitor combinations while maintaining orphan drug designation for pancreatic cancer in major markets. The company has also strengthened its financial position and regained compliance with NYSE American listing requirements, providing additional support for future development activities.
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Multiple Catalysts Expected Through 2027
With enrollment completed, AIM expects several important milestones over the coming months. Additional clinical updates from DURIPANC are anticipated before primary endpoint analyses begin in December 2026, followed by topline results expected during the first quarter of 2027. Secondary endpoint analyses, including progression-free survival, overall survival, immune monitoring, and biomarker assessments, are expected to begin in June 2027. The company also plans to continue regulatory discussions, expand its intellectual property portfolio, advance Phase 3 planning, and prepare for a potential registration-focused pivotal study. AIM believes these milestones could further validate Ampligen’s therapeutic potential while strengthening its long-term position in pancreatic cancer immunotherapy.
Source: AIM ImmunoTech press release
