AIM ImmunoTech Completes Final Patient Dosing In Phase 2 DURIPANC Trial Of Ampligen For Metastatic Pancreatic Cancer Ahead Of Schedule

AIM ImmunoTech Inc. (NYSE American: AIM) has announced that the final patient in its Phase 2 DURIPANC clinical trial has received the last scheduled dose of Ampligen® (rintatolimod), marking the completion of treatment ahead of schedule. The study is evaluating Ampligen in combination with AstraZeneca's immune checkpoint inhibitor Imfinzi® (durvalumab) as a potential treatment for metastatic pancreatic cancer.

With patient dosing now complete, the company will move into the planned data collection and analysis phase. AIM expects the primary endpoint analysis to begin in December 2026, with topline results anticipated in the first quarter of 2027. The primary endpoint of the DURIPANC trial is the Clinical Benefit Rate (CBR), which measures the percentage of patients who achieve stable disease, partial response, or complete response 24 weeks after starting the combination treatment.

The trial will also evaluate several important secondary endpoints, including overall survival, progression-free survival, and immune profiling. Analysis of the overall survival data is expected to begin in June 2027, approximately 49 weeks after the final patient received the first treatment dose. The immune profiling analysis is designed to identify biomarkers that may help determine which patients are most likely to benefit from Ampligen, potentially supporting the design of a future pivotal Phase 3 study.

AIM said the DURIPANC trial builds on encouraging observations from a Dutch Ministry of Health-approved Named Patient Program, where more than 50 patients with advanced pancreatic cancer received Ampligen after standard treatments were no longer effective. Although the program was not designed to evaluate the drug's effectiveness and the findings were exploratory, patients with a neutrophil-to-lymphocyte ratio below 4.5 showed a median overall survival of 34.8 months compared with 12.5 months reported in historical controls, representing a difference of 22.3 months. The company hopes similar trends will be confirmed in the ongoing Phase 2 trial.

Chief Executive Officer Thomas Equels said the survival results observed in the Named Patient Program are encouraging but must be confirmed through well-controlled Phase 2 and Phase 3 clinical trials before the therapy's effectiveness can be established. He added that completing key milestones in the DURIPANC study ahead of schedule reflects the company's commitment to advancing Ampligen's clinical development, evaluating biomarker-driven patient selection, and preparing for a pivotal Phase 3 trial that could support a future New Drug Application (NDA) for pancreatic cancer.

Metastatic pancreatic cancer remains one of the most difficult cancers to treat, with limited treatment options and poor long-term survival rates. AIM believes the combination of Ampligen and Imfinzi has the potential to improve outcomes by enhancing the body's immune response against cancer, and the upcoming clinical data will play an important role in determining the next steps for the program.