AIM ImmunoTech Bolsters Intellectual Property Portfolio for Ampligen® with Issuance of New Netherlands Utility Patent Covering Ampligen® and other AIM Developed dsRNA Products for Use in COVID-19 Treatment or Prevention
13 Juin 2022 - 2:05PM
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 ContactJTC Team, LLCJenene
Thomas833-475-8247AIM@jtcir.com
AIM ImmunoTech (AMEX:AIM)
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