On August 3, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the final subject has received their last dose of Ampligen (rintatolimod) under the study protocol, reaching this milestone ahead of schedule in the Phase 2 DURIPANC clinical trial evaluating Ampligen in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.
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Following planned data collection, DURIPANC 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 the DURIPANC Overall Survival Endpoint 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 – the gold standard in oncology trials – as well as progression-free survival and a completed immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best clinical benefit and overall survival results, which could be critical to the design of a pivotal Phase 3 clinical trial.
AIM saw encouraging results in a Dutch Ministry of Health-approved Named Patient Program that provided more than 50 post-standard of care pancreatic cancer patients with access to Ampligen as a monotherapy. While the program was not designed to assess efficacy and the findings were exploratory observations, analysis of biomarker stratifications was extremely promising. For example, Ampligen achieved a median Overall Survival of 34.8 months compared to 12.5 months for historical controls – for an improvement of 22.3 months – in the patient subset with immune biomarker Neutrophil/Lymphocyte ratios less than 4.5. AIM hopes to see similar trends in the final DURIPANC overall survival results.
AIM Chief Executive Officer Thomas Equels stated: "While the tremendous improvement in overall survival seen in our Named Patient Program is an important signal, it is one which requires Phase 2 and Phase 3 clinical trials to verify efficacy and support statistical validity. The execution of DURIPANC Phase 2 milestones ahead of schedule affirms our commitment to analyze biomarker stratifications as we set about designing a pivotal Phase 3 clinical trial that will help move Ampligen toward eventual submission of a New Drug Application for the treatment of pancreatic cancer."
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 and progression-free survival; 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, AUG 3, 2026, View Source [SID1234669602])