AIM ImmunoTech Announces Phase 2 Ampligen Trial Milestones for Pancreatic Cancer

AIM ImmunoTech Inc. (NYSE American: AIM) announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating 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).

DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands.

The planned DURIPANC milestones include completion of subject enrollment in July 2026 and completion of full Ampligen dosing for all subjects in August 2026. In December 2026, the company expects evaluation of the Primary Endpoint of Clinical Benefit Rate, defined as stable disease, partial response or complete response (progression-free disease) at 6 months (24 weeks) after start of combination therapy.

In June 2027, evaluation of the Secondary Endpoints is planned once the last subject reaches week 49. These secondary endpoints include Progression-Free Survival, defined as the time between the start of combination therapy with Ampligen and durvalumab to date of progression or death, whichever occurs first. Overall Survival is defined as the time between the start of combination therapy with Ampligen and durvalumab to date of death. Immunogenic efficacy is defined as greater than 50% increase in circulating Ki67+ CD 8+ T cell in peripheral blood evaluated 12 weeks after start of combination therapy. Infiltrating immune profile is defined as the change in infiltrating immune profile after start of combination therapy. Reporting of Quality of life (EORTC QLQ-C30) will be based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy.

AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. The lead investigator emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.

According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting "high quality of life" during treatment.

AIM has published on its website an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM's stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen (rintatolimod), for the treatment of late-stage pancreatic cancer. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.