AIM ImmunoTech Inc. Reports Phase 2 DURIPANC Study Progress Evaluating Ampligen® With AstraZeneca’s Imfinzi® In Metastatic Pancreatic Cancer Patients Post-FOLFIRINOX Therapy

AIM ImmunoTech Inc. announced recent milestones and updates in its ongoing Phase 2 clinical study evaluating Ampligen® (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, Imfinzi® (durvalumab), for patients with metastatic pancreatic cancer who have achieved stable disease following FOLFIRINOX standard-of-care therapy. The DURIPANC study, an investigator-initiated, exploratory, open-label, single-center trial, is being conducted in collaboration with AstraZeneca and Erasmus Medical Center in the Netherlands. To date, 18 patients have been enrolled in the study, which is designed to assess both safety and efficacy signals of the combination therapy.

The study has a clearly defined timeline of milestones, with patient enrollment expected to be completed by July 2026, followed by the completion of full Ampligen dosing for all participants in August 2026. The primary endpoint, Clinical Benefit Rate, will be evaluated in December 2026 and is defined as stable disease, partial response, or complete response at six months after initiating combination therapy. Secondary endpoints will be assessed in June 2027, once the last patient reaches week 49. 

These include Progression-Free Survival, measured from the start of therapy to disease progression or death, and Overall Survival, measured from the start of therapy to death. The study will also evaluate immunogenic efficacy, defined as a greater than 50% increase in circulating Ki67+ CD8+ T cells in peripheral blood 12 weeks after the start of therapy, as well as changes in the infiltrating immune profile in tumors. Patient-reported quality of life, using the EORTC QLQ-C30 questionnaire, will be assessed at baseline, six weeks, three months, nine months, and one year after beginning treatment.

AIM has committed to providing mid-year and year-end interim updates on DURIPANC progress, with the most recent report released in early February. Lead investigator Marjolein Y. V. Homs, MD, PhD, from the Department of Medical Oncology at Erasmus MC Cancer Institute, noted that encouraging trends in Progression-Free Survival and Overall Survival observed during the Phase 1 portion of the study have continued in Phase 2. 

She confirmed that patient enrollment is ongoing and that detailed study results are expected to be published later this year. The safety profile of Ampligen in the study has been favorable, with no significant toxicity reported, an important consideration for patients who have completed chemotherapy. Participants have also consistently reported high quality of life throughout the course of treatment, supporting the tolerability of the combination therapy.

In addition to clinical progress, AIM recently updated its corporate presentation to highlight the company’s priority goal of securing new drug approval for Ampligen in pancreatic cancer. The presentation details AIM’s research and development strategy, the proposed mechanism of action for Ampligen in pancreatic cancer, and the potential benefits of advancing the therapy into later-stage clinical trials. 

AIM believes that successfully moving Ampligen toward a Phase 3 trial could have substantial clinical and financial value, given the strong interest in oncology assets in late-stage development. Overall, the DURIPANC study represents a significant step in AIM ImmunoTech’s efforts to develop new therapeutic options for pancreatic cancer while advancing Ampligen toward regulatory approval and broader clinical impact.