AIM ImmunoTech Announces the Publication of Positive Data from the Advanced Pancreatic Cancer (EAP) Early Access Program in the Cancer Special Issue: Combination and Innovative Therapies for Pancreatic Cancer

Amplifier^® (rintatolimod) is being evaluated as a monotherapy to treat patients with pancreatic cancer under an early access program (EAP) approved by the Netherlands Health Care Inspectorate. Down at the Erasmus Medical Center

Ampligen treatment after FOLFIRINOX was associated with improved survival rates in patients with pancreatic cancer compared to matched controls of patients who did not receive Ampligen

Phase 2 study in patients with locally advanced pancreatic cancer expected to start in the second quarter of 2022

OCALA, Fla., March 08, 2022 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharmaceutical company focused on researching and developing therapies to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today announced the release of positive data from a single-center named patient program treating patients with advanced and metastatic pancreatic cancer. The manuscript entitled “Rintatolimod (Ampligen^®) increases peripheral B-cell counts and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pretreated with FOLFIRINOX: a single-center patient program named¹“, was published in the peer-reviewed journal, Cancer Special issue: Combination and innovative therapies for pancreatic cancer.

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 of 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 Ampligen’s potential to offer an important treatment option for patients with pancreatic cancer. This data now in hand plays a key role in the overall advancement of our pancreatic cancer program and provides valuable insights as we continue to chart the way forward. We continue to be encouraged by the favorable results demonstrated with Ampligen and are committed to securing the next phase of development for this important program,” commented Thomas Equels, President and CEO of AIM.

The primary endpoints of the study were systemic immuno-inflammation index (SIII), neutrophil-to-lymphocyte ratio (NLR), and absolute counts of 18 different populations of circulating immune cells, measured by flow cytometry . Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Median overall survival in the Ampligen group was 19 months, compared to a historical control group and a subgroup (7.5 and 12.5, respectively) who 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 after treatment with FOLFIRINOX and these results are compelling. We are encouraged by the data demonstrating that patients who were treated with Ampligen had 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,” said David Strayer, MD, Chief Medical Officer, Chief Scientific Officer of the company and Board Certified in Medical Oncology.

Professor Casper HJ van Eijck, MD, PhD, pancreatic-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 this positive data, I believe Ampligen has the potential to be a significant extension of the standard of care for advanced pancreatic cancer and can offer much-needed hope to patients and families. Of particular note, we were delighted to see the improved overall survival rates of our patients treated with Ampligen. These initial data suggest that Ampligen has the potential to be an important treatment for patients with pancreatic cancer, and I look forward to being 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 before Ampligen. Of the 27 patients, 25 patients completed the first cycle of Ampligen. Based on OS after treatment with Ampligen, the 27 patients were divided into 11 long-term survivors and 16 short-term survivors.

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

Highlights of key results

While at 6 weeks, the systemic immuno-inflammation index (SIII) and neutrophil-to-lymphocyte ratio (NLR) values of long-term and short-term patients combined showed no significant difference from Baseline values were found to be significantly lower in 11 long-term survivors compared to 16 short-term survivors.

The number of B cells increased significantly in long-term survivors. T cells and myeloid cells did not increase significantly after treatment with Ampligen.

Median PFS was significantly longer (13 months) with rintatolimod compared to matched controls and the matched control subset (5 and 8.6 months, respectively); the hazard ratio was 0.51; 95% CI 0.28-0.90, p=0.007.

Median overall survival was significantly longer (19 months) with Ampligen compared to matched controls and the subset of matched controls (7.5 and 12.5, respectively); the 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 metastasized disease were still alive.

Based on these data, the Company believes that Ampligen could be a potentially effective maintenance treatment after systemic chemotherapy in patients with advanced pancreatic cancer.

The Company plans to conduct a Phase 2 study of Ampligen as a treatment 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 after FOLFIRINOX for subjects with locally advanced pancreatic disease. carcinoma. Secondary objectives include comparison of 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 main study sites, although additional sites are planned.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immunopharmaceutical company focused on the research and development of therapies to treat several types of cancers, immune disorders and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus .

For more information, please visit www.aimimmuno.com.

Caution

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may”, “will”, “expect”, “plan”, “anticipate” and similar expressions (as well as other words or expressions referring to future events or circumstances) are intended identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for these statements, the Company claims safe harbor protection for forward-looking statements contained in the PSLRA. Although the Company believes that the results of the single center designated patient program mentioned above were positive, significant additional testing will be required. Among other things, the study included only a small number of selected patients and lacked randomization. Although the Company plans to sponsor a Phase 2 study, no assurance can be given that the study or any future study will be timely, successful or produce favorable data. In addition, studies and trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or changing priorities at sponsoring institutions. trials. There is also a risk of delays in clinical trial registration and notification due to the COVID-19 medical emergency. We previously noted that the FDA placed a clinical hold on our pancreatic cancer IND. However, we have corresponded with the FDA and expect, but cannot guarantee, that the hold will be lifted. The Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Investor Relations
JTC Team, LLC
jenene thomas
833-475-8247

AIM@jtcir.com

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¹Cancer 2022, 14(6), 1377; https://doi.org/10.3390/cancers14061377 (DOI registration)