OCALA, Fla. — September 22, 2026

AIM ImmunoTech Inc. highlighted the potential role of Ampligen® (rintatolimod) in pancreatic cancer following the U.S. FDA approval of Revolution Medicines’ daraxonrasib. AIM said Ampligen has a differentiated mechanism as a Toll-like receptor 3 (TLR3) agonist designed to activate innate immunity and influence the tumor microenvironment, distinguishing it from targeted RAS inhibition. The company also cited historical clinical data in a selected pancreatic cancer population in which Ampligen monotherapy was associated with a median overall survival of 34.8 months versus 12.5 months in matched historical controls, while emphasizing that further rigorous clinical trials are needed to establish the treatment’s efficacy.

Ampligen Targets Innate Immune Responses

Ampligen is designed to stimulate TLR3-mediated innate immune activity, with the potential to alter immune responses within solid tumors. AIM contrasted this mechanism with daraxonrasib, a selective RAS inhibitor that directly targets a major driver of pancreatic cancer. The company said Ampligen’s immune-modulating approach could potentially complement targeted therapies and checkpoint inhibitors by addressing biological barriers within the pancreatic tumor microenvironment. Ampligen has previously received FDA Orphan Drug designation for pancreatic cancer and is being investigated across multiple solid-tumor settings.

Historical Data Support Further Clinical Study

AIM highlighted a selected patient analysis from a Dutch government-approved Named Patient Program, involving pancreatic cancer patients with a blood neutrophil-to-lymphocyte ratio below 4.5. In that analysis, Ampligen monotherapy was associated with median overall survival of 34.8 months compared with 12.5 months in well-matched historical controls. The comparison is based on separate datasets and is not a randomized controlled trial, meaning the observed survival difference cannot establish a causal treatment effect. AIM said the findings provide a rationale for continued prospective clinical evaluation of Ampligen in pancreatic cancer.

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DURIPANC Evaluates Ampligen With Durvalumab

AIM is evaluating Ampligen in combination with AstraZeneca’s durvalumab in the Phase 2 DURIPANC study for patients whose pancreatic cancer remained stable following FOLFIRINOX treatment. The exploratory, open-label, single-center study is assessing the proportion of patients with stable disease or tumor response at 24 weeks following initiation of combination therapy. AIM expects topline DURIPANC results in Q1 2027, followed by a detailed overall survival analysis in Q3 2027. The company said results from the study are intended to inform parameters for potential subsequent pivotal development, although additional controlled trials would be required to establish Ampligen’s clinical benefit.

Source :AIM ImmunoTech, press release