AIM ImmunoTech Inc. reported follow-on data from its previously published single-center named patient program. For the study, patients with locally advanced pancreatic cancer or metastatic disease were treated following FOLFIRINOX. The enrollment of additional patients in the Early Access Program (EAP) was approved by the Inspectorate of Healthcare in the Netherlands and new patients have been treated at Erasmus M.C. The Overall and Progression-Free Survival was recently presented by Professor C.H.J. van Eijck, MD, PhD, of Erasmus Medical Center (Lead Investigator) at the 5th Dutch Multidisciplinary Gastrointestinal Oncology Congress held in Ermelo, Netherlands.

In addition, AIM has evaluated the initial data reported from Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and that data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months.

Based on the data demonstrated to date, the Company is advancing the development of Ampligen in a Phase 2 study to evaluate its potential as a therapy for locally advanced pancreatic cancer (AMP-270). AMP-270 is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability.

The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe (60 subjects in the Ampligen group and 30 subjects in the control group). The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites. To manage the AIM-sponsored Phase 2 study, on April 7, 2022, the Company engaged Amarex Clinical Research LLC, a CRO with a strong track record on advising sponsors through the product development process and providing customized solutions for clinical studies.

The AMP-270 clinical trial is on track to commence in Third Quarter 2022.