OCALA, Fla., Aug. 3, 2026

AIM ImmunoTech Inc. announced that the final patient has received the last protocol-defined dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen® (rintatolimod) in combination with AstraZeneca’s Imfinzi® (durvalumab) for the treatment of metastatic pancreatic cancer. Achieving this milestone ahead of schedule advances the study toward key clinical readouts, with the primary endpoint analysis expected to begin in December 2026 and topline results anticipated in the first quarter of 2027.

DURIPANC Advances Toward Key Clinical Benefit and Survival Readouts

The investigator-initiated DURIPANC trial is an open-label, single-center Phase 2 study conducted through a collaboration between AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The study is evaluating Ampligen in combination with the PD-L1 inhibitor Imfinzi (durvalumab) in patients with metastatic pancreatic cancer. The primary endpoint is Clinical Benefit Rate (CBR), measuring the proportion of patients achieving stable disease, partial response, or complete response 24 weeks after treatment initiation. Following completion of data collection, the primary endpoint analysis is scheduled to begin in December 2026, with topline efficacy results expected during Q1 2027. Secondary endpoints include overall survival, progression-free survival, immune profiling analyses, and quality-of-life assessments, with the overall survival analysis expected to begin in mid-2027.

Biomarker Findings Support Future Precision Medicine Strategy

AIM highlighted encouraging exploratory observations from a Dutch Ministry of Health-approved Named Patient Program, where more than 50 post-standard-of-care pancreatic cancer patients received Ampligen monotherapy. Although the program was not designed to demonstrate efficacy, patients with a neutrophil-to-lymphocyte ratio below 4.5 achieved a median overall survival of 34.8 months, compared with 12.5 months in historical controls. The company believes immune biomarker analyses incorporated into the DURIPANC trial could help identify patient populations most likely to benefit from treatment, providing important information for the design of a future pivotal Phase 3 clinical trial.

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Ampligen Program Progresses Toward Late-Stage Development

With final patient dosing completed ahead of schedule, AIM ImmunoTech continues advancing Ampligen® (rintatolimod) as a potential immunotherapy for one of the most challenging solid tumors. Ampligen is a double-stranded RNA (dsRNA) Toll-like receptor 3 (TLR3) agonist designed to stimulate anti-tumor immune responses. The company expects data from the ongoing DURIPANC study to guide future regulatory development, with successful Phase 2 outcomes potentially supporting the initiation of a pivotal Phase 3 program and eventual New Drug Application (NDA) submission for metastatic pancreatic cancer..

Source: AIM ImmunoTech, press release