On March 8, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported the publication of positive data from a single-center named patient program treating advanced and metastatic pancreatic cancer patients (Press release, AIM ImmunoTech, MAR 8, 2022, View Source [SID1234609637]). The manuscript titled, "Rintatolimod (Ampligen) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1," was published in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer.

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In the single-center named patient program, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen for 6 weeks, at 2 doses per week with 400 mg per infusion. The study found that Ampligen improved the median survival of these patients.

"We are very encouraged by these data, which we believe reaffirm the potential of Ampligen to offer an important treatment option to patients living with pancreatic cancer. These data now in hand play a key role in the overall advancement of our pancreatic cancer program and provide valuable insight as we continue to execute the path forward. We continue to be encouraged by the favorable results demonstrated with Ampligen and are committed to securing the next phase of development of this important program," commented Thomas Equels, Chief Executive Officer of AIM.

The study’s primary endpoints were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells as measured by flow cytometry. Secondary endpoints were progression-free survival (PFS) and overall survival (OS). The median overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.

"This is the first study investigating the immunomodulatory effect of the TLR-3 agonist Ampligen in patients with locally advanced or metastatic pancreatic cancer following FOLFIRINOX therapy and these results are compelling. We remain encouraged by the data demonstrating patients who were treated with Ampligen had a longer median PFS and overall survival compared to matched controls of patients who did not receive Ampligen. We look forward to further evaluation of Ampligen as a treatment for pancreatic cancer in our upcoming Phase 2 study," stated David Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the Company and Board Certified in Medical Oncology.

Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC and co-author of the published manuscript added, "There remains a critical need for more effective therapies to treat this devastating disease. Based on these positive data, I believe Ampligen has the potential to be a meaningful extension to the standard of care for advanced pancreatic cancer and may offer much needed hope for patients and families. Of particular note, we were pleased to see the improved overall survival rates of our patients treated with Ampligen. These initial data suggest Ampligen has the potential to be an important treatment for pancreatic cancer patients, and I look forward to being a part of the planned Phase 2 study."

From January 2017 to February 2019, a total of 42 patients with LAPC or metastasized disease were treated with Ampligen. Twenty-seven of the patients had been treated with FOLFIRINOX prior to Ampligen. Of the 27 patients, 25 patients completed the first cycle of Ampligen. Based on OS after Ampligen treatment, the 27 patients were divided into 11 long-term survivors and 16 short-term survivors.

Ampligen was administered in cycles of six weeks. Patients received treatment for a maximum of three cycles of six weeks or until progression. A treatment cycle consisted of twice per week intravenous administration of 200 milligrams in the first two weeks and 400 milligrams in the last 4 weeks. Laboratory assessments and peripheral blood sample collections for immunology flow cytometry analysis were obtained at baseline and 5 days after the last infusion of the first treatment cycle. Progression of disease was assessed by CT imaging scans according to RECIST criteria 1.1 and serum carbohydrate antigen 19-9 examinations every 3 months during follow-up, if clinically indicated or when recurrence was suspected.

Key Results Highlights

While at 6 weeks, the Systemic Immune-Inflammation Index (SIII) and the Neutrophils to Lymphocyte Ratio (NLR) values from the long-term and short-term patients combined showed no significant difference compared to baseline, the values were found to be significantly lower in 11 long-term survivors versus 16 short-term survivors.
The numbers of B-cells were significantly increased in long-term survivors. T-cells and myeloid cells were not significantly increased after treatment with Ampligen.
The median PFS was significantly longer (13 months) with rintatolimod compared to both matched controls and the subset of matched controls (5 and 8.6 months, respectively); hazard ratio was 0.51; 95% CI 0.28-0.90, p=0.007.
The median overall survival was significantly longer (19 months) with Ampligen compared to both matched controls and the subset of matched controls (7.5 and 12.5, respectively); hazard ratio was 0.52; 95% CI 0.28 – 0.90, p=0.016.
At the time of analysis in November 2021, a total of three patients with the metastasized disease were still alive.
Based on these data, the Company believes that Ampligen could be a potential effective maintenance therapy after systemic chemotherapy in patients with advanced pancreatic cancer.

The Company plans to conduct a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer. The planned AMP-270 clinical trial of approximately 90 subjects will 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 carcinoma. Secondary objectives include comparing safety and tolerability.

Amarex Clinical Research will manage the AIM-sponsored Phase 2 study. 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, although additional sites are anticipated.