AIM ImmunoTech Inc. (NYSE American: AIM) announced it has completed enrollment in its Phase 2 DURIPANC clinical study ahead of schedule and has dosed the final patient in the trial, according to a company press release.

The study is evaluating Ampligen (rintatolimod), a TLR3 agonist immunotherapy, in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. The trial is being conducted in collaboration with AstraZeneca and Erasmus Medical Center.

The company said primary endpoint analysis is anticipated to begin in December 2026, with topline results expected in the first quarter of 2027. Progression-free survival, overall survival, and other secondary endpoint assessments are expected to begin in June 2027.

AIM also reported that the drug combination has thus far shown no significant toxicity in study updates. The company maintains orphan drug designation for pancreatic cancer in major markets and has expanded its intellectual property portfolio covering Ampligen and checkpoint inhibitor combinations.

Additional milestones cited by the company include regaining compliance with NYSE American continued listing standards and completing financing transactions to support clinical operations.

"Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech.

The company said it is advancing Phase 3 planning activities and considering design and initiation of a registration-focused pivotal study, pending results from the ongoing Phase 2 trial.