AIM ImmunoTech Announces Print Publication and Further Positive Findings from a Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer Research
August 20 2024 - 8:30AM
AIM ImmunoTech Inc. (NYSE American:
AIM) (“AIM”) today announced the official print
publication of the data analysis from a long-term Early Access
Program (“EAP”) studying the company’s drug Ampligen®
(rintatolimod) for the treatment of advanced pancreatic ductal
adenocarcinoma (“PDAC”). The manuscript titled “Rintatolimod in
Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through
Dendritic Cell-Mediated T Cell Responses,” appears in the journal
Clinical Cancer Research, one of oncology’s most prestigious
journals.
Ampligen is a dsRNA product candidate that acts
via the TLR-3 receptor present on several immune cells, epithelial
cells and tumors. Researchers at the Erasmus University Medical
Center (“Erasmus MC”) found that Ampligen treatment in pancreatic
cancer patients enhances peripheral immune activity at the
transcriptomic and proteomic levels, particularly involving type 1
conventional dendritic cells (cDC1s) and T cells. Post-Ampligen,
the increased peripheral abundance of BTLA+XCR1+ cDC1s and
CD4+SELL+ T cells correlated with improved clinical outcomes.
Patients with stable disease exhibited pronounced overexpression of
genes related to DC and T cell activation. Notably, the expression
of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen
across all patients.
“We are grateful to the Erasmus team for their
continued contributions to the advancement of Ampligen,” said AIM
Chief Executive Officer Thomas K. Equels “There remains a large and
growing unmet need for safe and effective treatments for pancreatic
cancer. This data continues to provide us with further insight into
Ampligen’s ability to improve progression-free survival and overall
survival and enables us to identify cancer patients who might
benefit more from Ampligen treatment than they would from other
known cancer treatments.”
Prof. Casper H.J. van Eijck, MD, PhD,
Pancreato-biliary Surgeon at Erasmus MC and co-author of the
published paper, added, “We continue to be encouraged by this data
which suggests Ampligen infusions modulate PD-L1 and PD-L2
expression in the tumor microenvironment, while at the same time
they upregulate Ki67+CD4+ and Ki67+CD8+ T-cells. We continue to
make progress in the ongoing DURIPANC trial, which looks at the
combination effect of Ampligen and AstraZeneca’s durvalumab and
look forward to continuing evaluation of its potential for the
treatment of pancreatic cancer.”
In addition to the published manuscript, further
commentary discussing the potential of Ampligen and two other
drugs, referencing findings from the journal article, were
published. Key highlights from the additional commentary
include:
- Ampligen has been found to be also
safely used through a systemic route.
- Interesting increases in cDC1
numbers and cytokines governing T-cell activation and migration are
found to be upregulated.
- Researchers detected an important
enrichment of B-cell numbers in peripheral blood from patients
treated with Ampligen.
- B-cells correlated with long-term
(>1 year) survival in a previous study.
AIM is currently evaluating Ampligen as a
therapy for metastatic pancreatic ductal adenocarcinoma in the
Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy
for locally advanced pancreatic adenocarcinoma in the Phase 2
AMP-270 clinical study (NCT05494697).
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 X, 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. Publication of this data, and pre-clinical and
clinical success seen to date, does not guarantee that Ampligen
will be approved for the commercial treatment of cancers. 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. 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 the 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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