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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report January 10, 2024
AIM
IMMUNOTECH INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-27072 |
|
52-0845822 |
(state or other jurisdiction |
|
(Commission |
|
(I.R.S. Employer |
of incorporation) |
|
File Number) |
|
Identification No.) |
2117 SW Highway
484, Ocala FL |
|
34473 |
(Address of principal executive
offices) |
|
(Zip Code) |
Registrant’s
telephone number, including area code: (352) 448-7797
AIM
ImmunoTech Inc.
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
AIM |
|
NYSE
American |
Item
7.01. Regulation FD Disclosure.
Furnished
herewith as Exhibit 99.1 is a press release titled AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating Ampligen®
(rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer. This press release
references a video interview with Thomas K. Equels concerning the study, which is posted on the homepage of our website at
https://aimimmuno.com/whatthismeansvideo1/.
This
information, including Exhibit 99.1 and the video interview, referenced herein, 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
EXHIBIT
INDEX
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
AIM
IMMUNOTECH INC. |
|
|
|
January
10, 2024 |
By: |
/s/
Thomas K. Equels |
Exhibit
99.1
AIM
ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating
Ampligen® (rintatolimod) in Combination with AstraZeneca’s
Imfinzi®
(durvalumab) for the Treatment of Pancreatic Cancer
First
enrollment and first subject dosing expected soon at Erasmus Medical Center in Rotterdam, Netherlands
Management
discusses the announcement and what this means here: video
OCALA,
Fla., January 10, 2024 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced
that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen®
(rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of pancreatic
cancer (the “DURIPANC Study”). Ampligen has shown therapeutic synergies with checkpoint inhibitors, potentially increasing
survival rates and efficacy.
AIM
announced in January 2023 that it had entered into an external sponsored collaborative clinical research agreement with Erasmus
MC and AstraZeneca. The DURIPANC Study is an investigator-initiated, exploratory, open-label, single-center study with the full name
“Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic
ductal adenocarcinoma for therapy effect.” The primary objective of the Phase 1b portion is to determine the safety of combination
therapy with durvalumab and Ampligen. The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination
therapy.
Prof.
Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated,
“While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy
thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence that rintatolimod
treatment enhances the immune response by activating immune cells in advanced PDAC, as well as highlighting its potential synergy with
ICI therapy. Therefore, we are excited about the promise of combining Ampligen with durvalumab in a clinical study and we believe this
approach could make a positive impact in the current treatment landscape for patients with metastatic pancreatic cancer and extend overall
and progression free survival.”
AIM
recently received a U.S. patent for the use of Ampligen as part of a combination therapy with an anti-PD-L1 antibody.
AIM
Chief Executive Officer Thomas K. Equels stated: “We believe that Ampligen has potential as both a monotherapy and a combination
therapy, but a combination therapy could be much more enticing as a partnership or buyout target, as Ampligen would be enhancing an already
approved drug in an established and successful Big Pharma market. Essentially, we are working to show that combining Ampligen treatment
with an already established cancer treatment could help save even more lives.”
Hear
more from Tom Equels about the significance of this news in the latest “What this Means” video.
The
DURIPANC Study is expected to enroll up to 18 subjects in its Phase 1b portion and up to 25 patients in its Phase 2 portion. Subjects
will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to
400 mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy
FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2. Patients
will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with
the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST
1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
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 is a first-in-class investigational drug called
Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials
for globally important cancers, viral diseases and disorders of the immune system.
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,” “continue,”
“believe,” “potential,” “upcoming” and other variations thereon 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. The Company urges investors to consider specifically the
various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent
Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”). You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date of this press release. 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.
Investor
Contact:
JTC
Team, LLC
Jenene
Thomas
(833)
475-8247
AIM@jtcir.com
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Grafico Azioni AIM ImmunoTech (AMEX:AIM)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni AIM ImmunoTech (AMEX:AIM)
Storico
Da Mag 2023 a Mag 2024