AIM ImmunoTech Announces Publication of Positive Findings from a Pre-Clinical Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the American Journal of Cancer Research
27 Juni 2023 - 5:16PM
AIM ImmunoTech Announces Publication of Positive Findings from a
Pre-Clinical Study Evaluating Ampligen® in the Treatment of
Pancreatic Cancer in the American Journal of Cancer Research
AIM ImmunoTech Inc. (NYSE American:
AIM) (“AIM” or the “Company”), an immuno-pharma
company focused on the research and development of its TLR-3
agonist Ampligen (rintatolimod) as a novel and potentially powerful
therapeutic in locally advanced pancreatic cancer (“LAPC”) and
metastatic pancreatic cancer, today announced the publication of
pre-clinical data that suggests Ampligen has the potential to act
directly on tumor cells to reduce tumor cell growth in pancreatic
cancer patients with sufficient tumor levels of TLR-3, suggesting a
potential biomarker to identify patients who may respond to
Ampligen. The anti-tumor analysis was published in the
peer-reviewed journal American Journal of Cancer Research in the
paper “Rintatolimod: A potential treatment in patients with
pancreatic cancer expressing Toll-like receptor 3.”
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”) evaluated TLR-3 protein and mRNA expression
in thirteen pancreatic ductal adenocarcinoma (PDAC) tissue samples
as well as in the human PDAC (hPDAC) cell lines CFPAC-1, MIAPaCa-2
and PANC-1 using immunohistochemistry and multiplexed gene
expression analysis. The direct anti-tumor effects of Ampligen were
investigated using proliferation and migration assays after
different incubation time points with increasing concentrations of
Ampligen (ranging from 0.05 to 0.4 mg/ml).
After treating these three cell lines with
Ampligen, researchers observed significantly lower cell numbers
(amount of DNA per well, representing proliferation) and lower
migration rates only in the high TLR-3 expressing CFPAC-1 cells,
suggesting that the variating TLR-3 abundance of the three hPDAC
cell lines influences the effect of Ampligen on cell proliferation
and cell migration.
Prof. Casper H.J. van Eijck, MD, PhD,
Pancreato-biliary Surgeon at Erasmus MC and co-author of the
published paper, states: “An immune-modulating TLR-3 agonist such
as Ampligen is considered a promising novel treatment option for
pancreatic cancer and might have additional anti-tumoral effects on
epithelial tumor cells expressing TLR-3. Based on our findings, we
believe Ampligen is likely an agent offering anti-tumor effects and
potentially meeting the critical need for more effective therapies
to treat pancreatic cancer.”
AIM has a diverse clinical and business
portfolio concerning the treatment of pancreatic cancer:
- The AMP-270 Phase 2 clinical trial
is a randomized, open-label, controlled, parallel-arm study with
the primary objective of comparing the efficacy of Ampligen versus
a no treatment control group following FOLFIRINOX for subjects with
locally advanced pancreatic adenocarcinoma. Secondary objectives
include comparing safety and tolerability. (ClinicalTrials.gov:
NCT05494697)
- AIM entered into an external
sponsored collaborative clinical research agreement to support a
clinical trial at Erasmus MC combining AstraZeneca’s anti-PD-L1
immune checkpoint inhibitor durvalumab with Ampligen in patients
with metastatic pancreatic ductal adenocarcinoma. The study launch
is expected in Q4 2023.
- In March 2021, AIM was granted a
patent by the Netherlands Patent Office with granted patent claims
that include, but are not limited to, the use of Ampligen as a
combination cancer therapy with checkpoint blockade inhibitors
(e.g., pembrolizumab, durvalumab).
- AIM has been granted U.S. Food and
Drug Administration orphan drug designation status and European
Medicines Agency orphan medicinal product designation status for
Ampligen in the treatment of pancreatic cancer.
AIM CEO Thomas K. Equels states: “We remain
committed to establishing a new standard of care for pancreatic
cancer where there remains a significant unmet need. The data
generated to date, including the findings from this pre-clinical
study, continue to bolster our confidence in the potential of
Ampligen for the treatment of pancreatic cancer. These positive
results provide further validation as we continue to focus on
advancing our pancreatic cancer development program and execute on
our path forward.”
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” 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.
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