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Auris Medical Announces Significant Inhibition of Tumor Growth with OligoPhore siRNA Targeting NF-κB in Murine Model of Adult T-Cell Leukemia / Lymphoma

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  • 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: 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.

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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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