OCALA, Fla., June 13, 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, announced today that the Netherlands Patent Office (Octrooicentrum Nederland) has issued Patent No. 2027383 – a utility patent – covering Ampligen® (rintatolimod) and other AIM developed dsRNA products for use in the prevention or treatment of COVID-19, with a base patent term extending until 2041.
Ampligen is AIM’s RNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen is designed to modulate the immune system and has demonstrated anti-viral activity.
Thomas K. Equels, M.S. J.D., Chief Executive Officer of AIM, stated, “Over the course of the past few years, we have steadily been working to bolster and expand our patent portfolio covering COVID-19. This new utility patent in the Netherlands is directed to a composition comprising a therapeutic double-stranded RNA product being developed by AIM for use in treating or preventing a SARS-CoV-2 virus infection, including COVID-19 an infectious disease caused by a SARS-CoV-2 virus infection. In one embodiment, the therapeutic double-stranded RNA product may comprise Ampligen. In another patent embodiment, the therapeutic double-stranded RNA product may be one or more of a number of therapeutic double-stranded RNA (tdsRNA) developed by AIM. An example of such tdsRNA includes the rugged double-stranded RNA which is patented via composition of matter patent by AIM in the U.S. and worldwide. Data from in vitro, pre-clinical and clinical experiments strongly suggest that Ampligen has a broad-spectrum early onset anti-viral effect by stimulating a powerful innate immune response not stimulated by the target virus due to the virus’ characteristics which stymie the natural immune response inhibiting viral replication. This new utility patent is also directed to a composition comprising a vaccine against SARS-CoV-2 virus and Ampligen® designed to, in part, provide expanded immunity against future variants and also provide a similar response enhancing natural immunity post-infection, where Ampligen is administered as an early onset intranasal therapy.”
To date, AIM has established a growing patent portfolio covering Ampligen in its effort to join the global health community in the fight against the deadly coronavirus – as well as cancer – including:
- Three provisional patent applications filed in February 2020 for: 1) Ampligen as a therapy for the coronavirus; 2) Ampligen as part of a proposed intranasal universal coronavirus vaccine that combines Ampligen with inactivated coronavirus, conveying immunity and cross-protection; and 3) a high-volume manufacturing process for Ampligen. Under the Patent Cooperation Treaty of 1970 (PCT), which provides a unified procedure for filing patent applications to protect inventions in most countries, these three provisional patent applications were converted into two PCT patent applications claiming priority to the provisional patent applications. National patent application filings based on these PCTs, entitled to claim priority from the provisional patent applications, are ongoing.
- In June 2020, AIM filed a provisional patent application directed to compositions and methods for the treatment of Long COVID which is a wide range of new, returning, or ongoing health problems that people experience after first being infected with the virus that causes COVID-19. A PCT patent application was filed in June 2021 claiming priority to the June 2020 filing. National patent application filings based on this PCT and entitled to claim priority from the provisional patent application, are ongoing.
- In August and September of 2021, the Company filed two additional COVID-19-related provisional patent applications for: 1) Ampligen as both an intranasal and an intravenous therapy for what we describe as Post-COVID conditions; and 2) Ampligen as a potential early-onset intranasal therapy designed to enhance and expand infection-induced immunity, epitope spreading, cross-reactivity and cross-protection in patients exposed to a wide range of RNA respiratory viruses, such as influenza, Rhinoviruses and SARS-CoV-2.
- In March 2021, the Company was granted a patent by the Netherlands Patent Office with claims that include, but are not limited to, Ampligen and other AIM developed dsRNA products and checkpoint blockade inhibitors (e.g. pembrolizumab, nivolumab) for use as a combination cancer therapy. Interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial demonstrated that evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab and cisplatin. It is critical to note that increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. All told, the study has seen an Objective Response Rate (ORR) of 38.5%; a study (KEYNOTE-100) of pembrolizumab alone in the treatment of advanced recurrent ovarian cancer found Objective Response Rates of 8.1% and 9.9% across two cohorts. The positive data makes this patent have heightened potential. Similar patents are pending in other counties.
“This newly issued patent, along with other patents and patent applications, significantly support our goal of developing a prophylactic and early-onset therapy against COVID-19 and other deadly viruses. The issuance of this, and other patents, in the Netherlands is supportive of our extensive research program there. For example, AIM’s Ampligen intranasal safety study demonstrating Ampligen as well-tolerated and our groundbreaking pancreatic cancer research data all took place in the Netherlands. We look forward to advancing our research programs with our development partner in the Netherlands and importantly, taking another step toward a potential therapeutic for the treatment of multiple types of cancers, immune disorders, and viral diseases, including COVID-19,” concluded Mr. Equels.
AIM continues to execute on its strategic plan to develop an effective therapeutic for “Long COVID” with its investigational drug, Ampligen:
- In August 2020, AIM identified an effective in vitro model using human tracheal, bronchial epithelial cells at The Institute for Antiviral Research at Utah State University which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
- In November 2020, AIM disclosed positive pre-clinical results from a test by Japan’s National Institute of Infectious Diseases (NIID) This pre-clinical work determined that Ampligen, when used as a vaccine adjuvant, provided 100% survival in a pre-clinical rodent model of SARS-CoV as a surrogate model of SARS-CoV-2, in contrast to the control group, which demonstrated 100% mortality. The pre-clinical findings suggested Ampligen was generally well-tolerated by the experimental cohort.
- In early 2021, AIM launched a Phase 1 intranasal safety study of Ampligen, testing the safety, tolerability and biological activity of Ampligen at increasing doses, in anticipation of testing its potential as an intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. In June 2021, AIM announced that there were no Severe Adverse Effects observed in the study at any dosage level, thus establishing that Ampligen was well-tolerated when administered intranasally in humans.
- A June 2021 article in the medical journal Cancers stated that Ampligen has the potential to reduce the severity of COVID-19 by “activating the innate and the adaptive immune systems by activating a cascade of actions in human pancreatic cancer cells.”
- A Phase 3 prospective, double-blind, randomized, placebo-controlled trial of Ampligen in ME/CFS (AMP-516) produced objective improvement in exercise tolerance. An analysis of a subset of patients in that trial with early onset of symptoms showed a statistically significant 51.2% positive response (p=0.003) (See: PLOS ONE).
- In an amendment to its ongoing, U.S. Food and Drug Administration (“FDA”)-authorized AMP-511 (See: ClinicalTrials.gov) expanded access program (EAP), AIM has enrolled four post-COVID patients with new onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.003), despite the small number of patients.
Based in part on the early positive data seen to date, AIM is working toward filing an Investigational New Drug (“IND”) application with the FDA for a Phase 2 study of Ampligen for the treatment of Post-COVID conditions.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immune-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 plans to initiate 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 Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 treatments and COVID-19 Long Hauler treatment.
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. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for COVID-19 and Long COVID. Additionally, there is no guarantee as to when or whether an IND application will be submitted to the U.S. Food and Drug Administration, nor, if an application is submitted, whether it will be accepted.
Investor Relations Contact
JTC Team, LLC
Jenene Thomas
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