On June 18, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.
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With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate ("CBR"), defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy.
Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival ("OS") – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial.
AIM Chief Executive Officer Thomas K. Equels stated: "AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most likely to benefit from Ampligen-based therapy, thus supporting a more targeted and personalized treatment approach."
DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications:
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival ("PFS") of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, OS of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in OS
Based upon stratification for immune marker CA 19-9 less than 1000, PFS of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in PFS
Based upon stratification for immune marker CA 19-9 less than 1000, OS of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in OS
These results were accompanied by consistent reports of improved quality of life.
About DURIPANC
DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.
Read more about the DURIPANC study at ClinicalTrials.gov NCT05927142.
(Press release, AIM ImmunoTech, JUN 18, 2026, View Source [SID1234668796])