AIM ImmunoTech Announces Positive Phase 1b/2 Data for Ampligen and Imfinzi Combo in Late-Stage Pancreatic Cancer

AIM ImmunoTech Inc. (NYSE American: AIM) recently revealed promising preliminary results from their Phase 1b/2 study termed "DURIPANC," which investigates the combined use of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s Imfinzi® (durvalumab) for treating advanced pancreatic cancer. This exploratory, open-label, single-center study is spearheaded by researchers at Erasmus Medical Center (Erasmus MC) in the Netherlands.

The trial involves a dose escalation design, and the initial focus was on the safety of the combination therapy. In earlier announcements, AIM shared that the safety evaluation for the first dose level in the first group of subjects was completed successfully, with the combination therapy proving to be generally well-tolerated. Importantly, there were no severe adverse events or dose-limiting toxicities reported. Now, after a six-month assessment, two of the three patients in this first group have shown stable disease. These patients will continue to receive treatment and undergo formal evaluations of their disease progression every three months.

To determine the median progression-free survival (PFS), more than half of the subjects need to show disease progression. However, since 67% of the patients from the first group have maintained stable conditions at the six-month mark, AIM has not been able to report the PFS figures yet.

In the second group of patients, who are receiving a higher dose, two out of three patients also have stable disease. These patients have not yet reached the six-month stability assessment mark but will continue to be monitored closely.

Dr. Casper H.J. van Eijck, a Pancreato-biliary Surgeon at Erasmus MC and the Coordinating Investigator for the DURIPANC study, expressed optimism about the findings. He noted improvements in the quality of life for patients receiving the combination therapy and highlighted the absence of toxicity as a significant positive outcome. He underscored that, in comparison, approximately 80% of similar patients who did not receive this treatment experienced disease progression within three months. Dr. van Eijck remarked on the remarkable stability of the disease in several patients for six to seven months after maintenance therapy and even for 15 or more months following initial treatment with FOLFIRINOX. He is hopeful that the observed immune infiltration in metastatic lesions could lead to partial or complete responses in these patients.

Thomas K. Equels, AIM’s Chief Executive Officer, commented on the potential of Ampligen as part of combination therapy with checkpoint inhibitors. He emphasized that the recent data reinforces Ampligen’s promise for treating late-stage pancreatic cancer, a disease that remains a significant unmet medical challenge.

The study, registered under ClinicalTrials.gov NCT05927142, aims to explore the therapeutic effect of combining the anti-PD-L1 immune checkpoint inhibitor durvalumab with the TLR-3 agonist rintatolimod in patients suffering from metastatic pancreatic ductal adenocarcinoma.

AIM ImmunoTech Inc. is an immuno-pharmaceutical company dedicated to the development of therapeutics for various types of cancers, immune disorders, and viral diseases, including COVID-19. Their lead product, Ampligen® (rintatolimod), is a first-in-class investigational drug with broad-spectrum activity, undergoing clinical trials for its potential in treating globally significant cancers, viral diseases, and immune system disorders.