Ocala, Florida | June 18, 2026
AIM ImmunoTech Inc. announced that the final patient has received the first dose in the Phase 2 DURIPANC clinical trial, marking an important development milestone for its investigational immunotherapy Ampligen® (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of metastatic pancreatic cancer. Completion of first-dose enrollment enables the study to progress toward its scheduled efficacy evaluations, with primary endpoint analysis expected to begin in December 2026 and topline clinical results anticipated during the first quarter of 2027. The trial is designed to evaluate whether the combination therapy can improve outcomes in one of the deadliest cancers, where treatment options remain limited and survival rates continue to be among the lowest across oncology indications. The study is expected to generate critical clinical evidence supporting the design of a future pivotal Phase 3 clinical trial.
Phase 2 Study Evaluates Clinical Benefit and Long-Term Survival Outcomes
The DURIPANC study is an investigator-initiated, open-label, single-center Phase 2 clinical trial conducted through a collaboration between AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The study’s primary endpoint is the Clinical Benefit Rate (CBR), measuring the percentage of patients achieving stable disease, partial response, or complete response at 24 weeks following initiation of combination therapy. Beyond disease control, investigators will evaluate several important secondary endpoints, including Overall Survival (OS), Progression-Free Survival (PFS), immune profiling, and quality-of-life assessments. Secondary analyses are expected to begin in June 2027, approximately 49 weeks after the final enrolled patient received treatment. These endpoints will provide valuable insight into the long-term clinical activity of the Ampligen and durvalumab combination while helping researchers better understand immune responses associated with treatment effectiveness in metastatic pancreatic cancer.
Biomarker Research May Support Personalized Phase 3 Development
A major objective of the DURIPANC program is the identification of predictive biomarkers that may help determine which patients derive the greatest benefit from treatment. AIM ImmunoTech plans to analyze exploratory immune profiling data to identify potential “super-responder” patient populations, supporting a more personalized treatment strategy in future clinical development. The company’s approach builds upon encouraging findings from its earlier Named Patient Program conducted with Erasmus Medical Center, where Ampligen monotherapy demonstrated promising survival improvements among biomarker-selected patients. Previous analyses suggested patients with favorable neutrophil-to-lymphocyte ratios experienced progression-free survival of 17.7 months and overall survival of 34.8 months, substantially exceeding historical control data. Similarly, patients with CA 19-9 levels below 1000 demonstrated prolonged progression-free and overall survival, while improvements in patient-reported quality of life were also observed. These encouraging observations have provided the scientific rationale for expanding evaluation of Ampligen in combination with immune checkpoint inhibition.
Study Could Shape Future Treatment Strategies for Pancreatic Cancer
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Metastatic pancreatic cancer remains one of the most aggressive and difficult-to-treat malignancies, with limited therapeutic advances despite ongoing research. Ampligen, a double-stranded RNA (dsRNA) selective Toll-like receptor 3 (TLR3) agonist, is designed to stimulate innate immune responses and potentially enhance the activity of immunotherapies such as durvalumab. By combining immune activation with PD-L1 checkpoint blockade, investigators hope to improve anti-tumor immune responses in patients with advanced disease. According to AIM ImmunoTech, biomarker-driven analyses from DURIPANC may provide critical information for designing a Phase 3 registration-directed clinical trial, allowing future studies to focus on patients most likely to benefit from treatment. With enrollment milestones now completed and key efficacy analyses scheduled over the coming year, the DURIPANC program represents an important step in evaluating Ampligen-based combination immunotherapy as a potential new treatment option for patients living with metastatic pancreatic cancer.
Source: AIM ImmunoTech press release
