Item
7.01. Regulation FD Disclosure.
AIM
ImmunoTech Inc. (the “Company” or “AIM”) is providing this update on efforts being undertaken by Shionogi
& Co. Ltd. (Shionogi”) and Japan’s National Institute of Infectious Diseases (the “NIID”) for the
potential use of Ampligen as part of a COVID-19 vaccine, and the tripartite agreement between AIM, Shionogi and the NIID related
to Ampligen as a potential adjuvant for an NIID COVID-19 vaccine candidate whose primary component, known as the antigen, is a
protein molecule that triggers an immune response specific to the COVID-19 virus. This is created using a method known as the
baculovirus-expression vector system (“BEVS”).
The
Japan Agency for Medical Research and Development (“AMED”) has expressed support for efforts in Japan in a recent
publication: “‘The products of BEVS have already been used in human papillomavirus vaccine and influenza HA vaccine,’
says Hideki Hasegawa, director of the NIID’s Influenza Virus Research Center, and the project’s principal investigator.
‘Through our experience of influenza vaccine studies, we know that serum IgG antibodies are not protective against viral
infection in upper respiratory epithelial cells. Secretory IgA antibodies instead play an essential role in the prevention of
respiratory tract infection. So our final target is a COVID-19 mucosal vaccine which induces protective secretory IgA antibody
in the respiratory tract mucosa.’” (see AMED’s advertisement, which mentions AIM, “How AMED is supporting
Japanese researchers tackling the novel coronavirus”, Nature Research, September 23, 2020, a copy of which
is furnished herewith as Exhibit 99.1). (See also: Ichinohe J Infect Dis. 2007, Overton Vaccine 2014 and AIM PR February
11, 2020)
Like
many vaccines, the NIID candidate also contains a molecule known as an adjuvant, which aims to strengthen the immune response,
and reduce the amount of antigen required. The team is planning to use a TLR9 or TLR3 (Ampligen) agonist as the adjuvant, according
to Hasegawa, who is also collaborating with Kyushu University and Florida-based AIM ImmunoTech Inc. for adjuvant candidates.
AIM
has made two shipments of Ampligen to Japan, first to the NIID and subsequently to Shionogi directly. Shionogi stated, “On
26th Aug., Shionogi most recently received Ampligen (80 frozen vials) provided by AIM. Shionogi has continuously conducted immunogenicity
tests in mice in collaboration with the National Institute of Infectious Diseases (NIID) to examine the multiple candidate antigen
proteins including candidate adjuvants.”
The
information in this item, including Exhibit 99.1, is “furnished” and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It
may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities
Act of 1933, as amended, if and to the extent such subsequent filing specifically references the information herein as being incorporated
by reference in such filing.
Cautionary
Statement
This
Current Report on Form 8-K contains forward-looking statements that involve a number of risks and uncertainties. Among other things,
for those statements, we claim the protection of safe harbor for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements set forth in this Report speak only as of the date of this Report.
We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the
date hereof. For example, according to the advertisement, the NIID candidate contains a molecule known as an adjuvant and the
team is planning to use a TLR9 or TLR3 agonist. No assurance can be given that the Company’s Ampligen (a TLR3 agonist) will
be chosen. In addition, significant additional testing and trials will be required to determine whether Ampligen will be effective
in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models
do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be
efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful
or yield favorable data and the 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. In addition, initiation of planned clinical trials may
not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials
are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional
funding. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for
COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving
this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately
unproductive. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing
intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.
We
note that some of the information provided in this Report is from the AMED advertisement furnished herewith as Exhibit 99.1. According
to the advertisement, AMED “was established by the Japanese government in 2015 to support medical R&D in various fields,
ranging from basic research to clinical trials. AMED is funding at least five research projects related to COVID-19.” The
advertisement states: “As the world struggles to adjust to a new normal with the novel coronavirus, researchers around the
globe are working to end the pandemic. In Japan, AMED is supporting scientists to contribute to the international effort to develop
a vaccine, as well as drugs to treat COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).”