AIM ImmunoTech (NYSE American: AIM) announced plans to advance rintatolimod (Ampligen) into a Phase III trial for late-stage pancreatic ductal adenocarcinoma, citing qualitative signals from an ongoing Phase II study and a Dutch named patient program, though no quantitative efficacy data were disclosed.
The ongoing DURIPANC study is a Phase II trial evaluating rintatolimod in combination with AstraZeneca's durvalumab in late-stage pancreatic ductal adenocarcinoma, conducted in collaboration with Erasmus Medical Center.
AIM reported that DURIPANC is showing improvement in progression-free survival and overall survival alongside a favorable safety profile, but released no numerical data to support those characterizations. Enrollment is expected to complete later in 2026. Earlier, a Dutch government-approved named patient program administered rintatolimod as monotherapy to 82 patients with late-stage pancreatic ductal adenocarcinoma and reported positive findings on both progression-free and overall survival compared to historical controls; that program is the subject of a 2022 publication in Cancers. The company also referenced positive Phase I/II safety and efficacy data from combinations with durvalumab and Merck's pembrolizumab, again without providing specific figures. In total, AIM states more than 100 subjects have been treated across its pancreatic programs.
Rintatolimod's TLR3 agonism
Rintatolimod is a synthetic double-stranded RNA that acts as a selective TLR3 agonist, activating innate immune signaling and promoting interferon-mediated responses. The mechanistic rationale for combining a TLR3 agonist with a PD-L1 checkpoint inhibitor such as durvalumab is that innate immune priming may increase tumor immunogenicity and improve responsiveness to adaptive checkpoint blockade — a hypothesis that has gained traction in immunologically "cold" tumors like pancreatic ductal adenocarcinoma, where checkpoint monotherapy has largely failed. Cross-trial comparisons are limited by differences in patient selection, prior treatment history, and endpoints, so the DURIPANC signals cannot be directly benchmarked against other immunotherapy combinations in this disease.