- Treatment of
KRAS-driven colorectal cancer selected as first therapeutic
indication for OligoPhore™ platform
- Company to
launch development program under project code AM-401 with aim of
IND submission in late 2022
Hamilton, Bermuda, July 6, 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 selection of mutant KRAS-driven colorectal cancer as the first
therapeutic indication for its OligoPhore™ oligonucleotide delivery
platform. The Company intends to develop the treatment under
project code AM-401 with submission of an IND targeted for the end
of 2022.
Addressing high unmet medical
need
Colorectal cancer (CRC) is the fourth most
commonly diagnosed cancer and the second leading cause of cancer
death in the US.1 In 2021, there will be an estimated 149,500 new
cases of CRC in the US, and 52,980 deaths from CRC.2 Approximately
40 to 50% of patients with CRC harbor mutations of the KRAS gene,3
which are known to contribute to the development, invasion and
metastasis of CRC. KRAS encodes the Ras protein which controls -
like an “on / off switch” – cell growth, cell maturation, and cell
death. Through the mutations, the Ras proteins can be rendered
persistently active, causing cancer cells to grow and spread in the
body.
Beside CRC, KRAS mutations are frequently
observed in pancreatic cancer and lung cancer. Approximately 19% of
patients with cancer harbor Ras mutations, equivalent to
approximately 3.4 million new cases per year worldwide.4 Mutations
in KRAS alone account for approximately one million deaths per year
worldwide.5 Although the role of KRAS mutations in cancer has been
known for decades, they have remained a challenging target for
therapeutic interventions. Only recently two small molecule
inhibitors of single KRAS mutations were approved in a breakthrough
by the Food and Drug Administration (FDA) for use in the treatment
of non-small cell lung cancer (NSCLC).
Compelling results in KRAS-driven models
of colorectal and pancreatic
cancer
The selection of CRC as the first therapeutic
indication for the OligoPhore™ technology was made based on the
high unmet medical need, compelling outcomes from studies with
OligoPhore™ enabled KRAS silencing, and a well-defined regulatory
and development pathway. In vitro and in vivo experiments conducted
jointly by research teams from Washington University, St. Louis MO
and the University of South Florida, Tampa FL, demonstrated
efficient uptake of OligoPhore™ nanoparticles with KRAS-targeted
siRNA in colorectal and pancreatic cancer cells, strong inhibition
of KRAS expression, reduced viability of tumor cells and
significant reduction in tumor growth and volume.6 Importantly, a
murine model demonstrated the capacity of the OligoPhore™ platform
to drive targeted delivery of the nanoparticles specifically to
tumor cells.
“In our preclinical studies with OligoPhore
enabled siRNA delivery, we have demonstrated potent knock down of
KRAS in a highly targeted and effective fashion, which inhibited a
key driver of cancer cell proliferation and metastases”, commented
Samuel Wickline, MD, Auris Medical’s Chief Scientific Officer.
“Based on these compelling data and the results from our extensive
review of strategic development options, we look forward to
advancing OligoPhore first in colorectal cancer before applying the
technology also to other therapeutic indications. Thanks to its
flexibility and specificity, OligoPhore can be used to
simultaneously deliver different siRNA payloads for broad target
inhibition, which opens exciting novel therapeutic options.”
About
OligoPhore™
OligoPhore™ is a versatile platform for safe and
effective delivery of oligonucleotides such as siRNA (small
interfering ribonucleic acid) into target cells, using systemic or
local administration. It is based on a proprietary 21 amino acid
peptide that can engage any type of RNA, including mRNA, 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. OligoPhore™
protects the RNA payload from degradation in the circulation and
allows for rapid cellular uptake, while enabling pH-dependent
nucleotide full endosomal escape and cytoplasmic delivery.
Effective delivery and positive treatment outcomes have been
demonstrated in more than 10 diverse murine models of disease for
cancer, cardiovascular, and rheumatological 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 (OligoPhore™ /
SemaPhore™ platforms; preclinical), nasal sprays for protection
against airborne viruses and allergens (Bentrio™; 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 Benson AB et al. (2021), NCCN clinical practice guidelines in
oncology, colon cancer, version 2.2021, JNCCN 19(3):329-59. 2
National Cancer Institute,
https://seer.cancer.gov/statfacts/html/colorect.html 3 Armstrong SA
et al. (2020), Molecular profiling in metastatic colorectal cancer,
Oncology (Williston Park) 34(9):352-5.4 Prior IA et al. (2020), The
frequency of Ras mutations in cancer, Cancer Res 80(14):2969-74.5
Simanshu DK et al. (2017), RAS proteins and their regulators in
human disease, Cell 170(1):17-33.
6 Strand MS et al. (2019), Precision Delivery of
RAS-inhibiting siRNA to KRAS driven cancer via peptide-based
nanoparticles, OncoTarget 10(46):4761-75.
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