On June 1, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company’s original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).
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The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study’s primary endpoint, Clinical Benefit Rate ("CBR"), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers.
AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks.
"This achievement represents another important execution milestone for the DURIPANC program and further strengthens the momentum behind Ampligen in pancreatic cancer," said AIM Chief Executive Officer Thomas K. Equels. "We continue to observe encouraging survival outcomes, consistently high quality-of-life measures and Ampligen’s strong safety profile. Together with our ongoing Phase 3 planning efforts, orphan drug designations in the United States and Europe, expanding global intellectual property portfolio, and growing body of positive clinical data, we believe Ampligen is advancing toward a significant value-inflection period for AIM and, most importantly, toward addressing a critical unmet need for pancreatic cancer patients."
Mr. Equels continued, "We remain on track to complete Ampligen dosing for all subjects in August, which should allow us to evaluate the study’s critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy."
The enrollment milestone further advances AIM’s broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company’s strategy of advancing Ampligen toward pivotal-stage development.
DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life.
Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.
(Press release, AIM ImmunoTech, JUN 1, 2026, View Source [SID1234666293])