AIM ImmunoTech Reports Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® (Rintatolimod) in Healthy Subjects

Intranasal administration of Ampligen demonstrated to be well-tolerated

Based on data generated to date, Ampligen could have potential as a prophylactic or early treatment against respiratory viral infections

Data presented in poster presentation at the British Society for Immunology Congress 2022

OCALA, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) — 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, today reported that data were recently presented by Lisanne C.A. Smidt – Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 . The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.

The study found:

• Repeated intranasal administration of Ampligen was well tolerated. No severe or serious AEs reported
• Solicited local AEs were comparable across all treatment groups and placebo
• An increase in IL-6, IL-8, and TNF production was observed for both Ampligen and placebo after dosing
• MCP-1 and RANTES — which are important immunomodulators — peaked 3-24 hours after administration, mainly for 500 μg Ampligen
• At doses evaluated, intranasal Ampligen administration did not drive a significant change in nasal immune cell abundance

The presented poster is available to view on the Events & Presentations page of the Company’s website.

AIM Chief Executive Officer Thomas K. Equels stated: “The results from this Phase 1 study evaluating intranasal Ampligen in healthy subjects support the promising potential in the ability of Ampligen to inhibit respiratory viruses at the point of entry. The repeated intranasal dosing regimen was shown to be well tolerated in all tested dose levels. These Phase 1 data, in combination with the prior promising results of in vitro modelling which demonstrated that Ampligen could decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, continue to be encouraging as we advance the development of Ampligen as a potential intranasal prophylactic approach to prevent infection and spread of COVID-19.”

In a randomized, double-blind, placebo-controlled, dose-escalation study, Ampligen (75µg, 200µg, 500µg, 1250µg) or placebo (4:1) was administered in both nostrils every other day, for a total of 7 consecutive doses. Safety and tolerability were monitored for 28 days after first dosing. To characterize the mucosal immune response, nasal mucosal samples were obtained frequently, especially around first and last dose (pre-dose, 3h, 6h, 24h and 48h post-dose). Type I interferons (IFN-α, IFN-β), NFκB-mediated cytokines (IFN-g, IL-6, IL-8, TNF) and chemokines (CXCL10, RANTES, MCP-1) were measured. Mucosal immune cells (granulocytes, monocytes, dendritic cells, NK-cells, T-cells and B-cells) were characterized using spectral flow cytometry. A total of 40 adult subjects were enrolled in the study.

David R. Strayer, M.D., AIM’s Chief Scientific & Medical Officer, stated: “Ampligen, AIM’s synthetic double-stranded RNA (Poly I:Poly C12U), is a Toll-like receptor 3 (TLR3) agonist, inducing type-I interferons. Intranasal administration of Ampligen could induce an innate mucosal immune response, thereby inhibiting respiratory viruses at the point of entry. Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. We have conducted laboratory experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. Ampligen is currently being evaluated for the safety and effectiveness to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients.”

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is 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 Company’s lead product, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system.

Ampligen is currently being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM has commenced a Phase 2 clinical study in 2022. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

Cautionary Statement

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 referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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