Auris Medical Announces Significant Inhibition of Tumor Growth with OligoPhore siRNA Targeting NF-κB in Murine Model of Adul...
21 Junio 2021 - 7:30AM
- Treatment with
OligoPhoreTM siRNA stops aggressive ATLL tumor growth to near
zero
- Significant
reduction in tumor size, spleen size and peripheral blood
lymphocyte counts
- Results add to
extensive body of evidence for effective OligoPhoreTM enabled
delivery of nucleic acids to extrahepatic tissues
Hamilton, Bermuda, June 21, 2021 – Auris Medical
Holding Ltd. (NASDAQ: EARS), a company dedicated to addressing
unmet medical needs through RNA therapeutics, allergy and viral
infection protection, and inner ear therapeutics, today announced
the publication of positive results from an in vivo study
demonstrating significant inhibition of tumor growth by siRNA
knock-down of NF-κB employing its OligoPhoreTM technology in Adult
T-cell Leukemia Lymphoma (ATLL). The article titled "Targeting
NF-κB with nanotherapy in a mouse model of adult T-cell leukemia /
lymphoma” was published in Nanomaterials, an international
peer-reviewed open-access journal.1
The study was performed jointly by research
groups at Washington University, St. Louis MO, and the University
of South Florida, Tampa FL. The researchers developed and evaluated
RNA nanoparticles based on Auris Medical’s OligoPhoreTM peptide
carrier and siRNA targeting simultaneously two NF-κB signaling
pathways. NF-κB is a protein complex that plays a key role in
regulating the immune response to infection and is critical for
tumor progression in ATLL. The siRNA nanoparticles were
administered systemically to two groups of mice with either
spontaneous ATLL tumor growth or tumor cell transplantation.
The study demonstrated rapid delivery of siRNA
to the tumor and significant reduction of target mRNA and protein
expression, which altered the natural history of subsequent tumor
progression. Tumor size, spleen size, and peripheral blood
lymphocyte counts were significantly lower in treated mice compared
to controls (p<0.01), and tumor growth was reduced to near zero
in the most aggressive tumors. Further, the siRNA nanoparticles
sensitized late-stage ATLL tumors to conventional chemotherapy with
etoposide.
ATLL is a rare and aggressive type of
non-Hodgkin’s lymphoma of mature T cells caused by the Human T-cell
Leukemia / Lymphotropic Virus type 1 (HTLV 1). It can be found in
the blood, lymph nodes, skin or other parts of the body. There are
5-10 million people infected with HTLV 1 globally, and it is
estimated that 61 out of 100,000 of carriers will develop ATLL
annually. The virus is endemic to Japan, sub Saharan Africa, South
America, the Caribbean, central Australia, the Middle East, and
Romania. Most cases are not curable with current treatments, even
when diagnosed early. The 5-year survival rate is 23.4% with a
median survival of 11 months. Overall survival has remained
unchanged since the disease was first described.
“We are very excited about the very encouraging
results from the study in ATLL mice”, commented Samuel Wickline,
MD, Auris Medical’s Chief Scientific Officer. “ATLL is a very
challenging condition with high mortality rate. Although NF-κB has
been known for some time as a promising target, it has remained
elusive to specific and effective treatment so far. With the use of
OligoPhore technology, siRNA targeting NF-κB can be delivered
intravenously and track the tumor very effectively with profound
suppression of aggressive tumor proliferation. Since ATLL is a
highly malignant tumor with no targeted molecular therapy at
present, this outcome is not only very encouraging for drug
discovery and development in this therapeutic indication, but also
for other tumors and inflammatory pathological conditions involving
the NF-κB molecular target.”
About
OligoPhoreTM
OligoPhoreTM is a versatile platform for safe
and effective delivery of oligonucleotides such as siRNA (small
interfering ribonucleic acid) into target cells. It is based on a
proprietary 21 amino acid peptide that can engage any type of RNA
in rapid self-assembly into a polyplex. The polyplex has a size,
charge, and other physical features that allow it to escape hepatic
clearance and thus to reach other target tissues than the liver.
OligoPhoreTM protects the RNA payload from degradation in the
circulation and allows for rapid cellular uptake, while enabling
pH-dependent nucleotide endosomal escape and cytoplasmic delivery.
Effective delivery and positive treatment outcomes have been
demonstrated in more than 10 murine models of disease for targets
in the NF-κB family, various members of the ETS transcription
factor family, and targets in the JNK and TAM pathways.
About Auris Medical
Auris Medical is dedicated to developing
therapeutics that address important unmet medical needs. The
Company is currently active in three areas: the development of RNA
therapeutics for extrahepatic therapeutic targets (OligoPhoreTM /
SemaPhoreTM platforms; preclinical), nasal sprays for protection
against airborne viruses and allergens (BentrioTM; pre-commercial)
or the treatment of vertigo (AM-125; Phase 2), and the development
of therapeutics for intratympanic treatment of tinnitus or hearing
loss (Keyzilen® and Sonsuvi®, Phase 3). The Company was founded in
2003 and is headquartered in Hamilton, Bermuda with its main
operations in Basel, Switzerland. The shares of Auris Medical
Holding Ltd. trade on the NASDAQ Capital Market under the symbol
“EARS.” The Company will change its name to “Altamira Therapeutics
Ltd.” and its ticker symbol to “CYTO”, subject to approval by a
Special General Meeting of shareholders to be held on July 21,
2021.
Forward-looking Statements
This press release may contain statements that constitute
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements are statements
other than historical facts and may include statements that address
future operating, financial or business performance or Auris
Medical’s strategies or expectations. In some cases, you can
identify these statements by forward-looking words such as “may”,
“might”, “will”, “should”, “expects”, “plans”, “anticipates”,
“believes”, “estimates”, “predicts”, “projects”, “potential”,
“outlook” or “continue”, or the negative of these terms or other
comparable terminology. Forward-looking statements are based on
management’s current expectations and beliefs and involve
significant risks and uncertainties that could cause actual
results, developments and business decisions to differ materially
from those contemplated by these statements. These risks and
uncertainties include, but are not limited to, the approval and
timing of commercialization of AM-301, Auris Medical’s need for and
ability to raise substantial additional funding to continue the
development of its product candidates, the timing and conduct of
clinical trials of Auris Medical’s product candidates, the clinical
utility of Auris Medical’s product candidates, the timing or
likelihood of regulatory filings and approvals, Auris Medical’s
intellectual property position and Auris Medical’s financial
position, including the impact of any future acquisitions,
dispositions, partnerships, license transactions or changes to
Auris Medical’s capital structure, including future securities
offerings. These risks and uncertainties also include, but are not
limited to, those described under the caption “Risk Factors” in
Auris Medical’s Annual Report on Form 20-F for the year ended
December 31, 2020, and in Auris Medical's other filings with the
SEC, which are available free of charge on the Securities Exchange
Commission's website at: www.sec.gov. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those indicated. All forward-looking statements and all
subsequent written and oral forward-looking statements attributable
to Auris Medical or to persons acting on behalf of Auris Medical
are expressly qualified in their entirety by reference to these
risks and uncertainties. You should not place undue reliance on
forward-looking statements. Forward-looking statements speak only
as of the date they are made, and Auris Medical does not undertake
any obligation to update them in light of new information, future
developments or otherwise, except as may be required under
applicable law.
Investor contact:
investors@aurismedical.com
1 Rauch DA et al. Targeting NF-κB with
nanotherapy in a mouse model of adult T-cell leukemia/lymphoma.
Nanomaterials 2021, 11(6), 1582.
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