•Company’s novel drug development program AM-411 builds on positive animal data •Treatments for rheumatoid arthritis represent the second largest therapeutic area globally •AM-411 to run concurrently with AM-401 (KRAS-driven cancers) to leverage platform data
Hamilton, Bermuda, July 25, 2022 (GLOBE NEWSWIRE) —
HAMILTON, BERMUDA / July 25, 2022 / Altamira Therapeutics (“Altamira” or the “Company”) (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced the initiation of a development program based on its proprietary OligoPhoreTM delivery platform and siRNA targeting NF-κB, for a novel generation of rheumatoid arthritis (RA) therapeutics. The Company intends to develop the drug product under project code AM-411 with the objective of out-licensing it at a later stage in accordance with its partnering strategy.
OligoPhore particularly well suited for targeted RNA delivery in rheumatoid arthritis
“The treatment of arthritis is one of the most promising indications for application of our patented OligoPhore platform,” commented Covadonga Pañeda, Ph.D., Altamira Therapeutics’ Chief Development Officer. “By design, OligoPhore is delivering siRNA specifically to inflamed tissues, which in the case of RA is primarily the inflamed joints. The treatment is thus sparing non-inflamed tissues and avoiding the systemic side effects frequently observed with current treatment options. In addition, using siRNA to control a key inflammatory checkpoint promises not only potent treatment effects, but also a much-reduced risk of developing treatment resistance, another frequent issue with current treatment options.”
AM-411 is the second RNA-based development project pursued by Altamira, along with project AM-401 which is targeting KRAS-driven cancers affecting the pancreas, lungs or colorectum, among others. Altamira aims to become a leading provider of peptide-based polyplex technology for extrahepatic RNA delivery and will actively seek out-licensing opportunities for AM-401 and AM-411 as well as for its OligoPhore and SemaPhoreTM platforms to other biopharmaceutical companies. As part of its ongoing refocusing around RNA therapeutics, Altamira is planning to divest or spin off its legacy business outside RNA.
Rheumatoid arthritis is a major autoimmune disease
RA is a chronic inflammatory condition causing joint swelling and pain which may also affect other areas, including the skin, eyes, brain, and cardiovascular system. In the US, approximately 1.3 million adults suffer from RA;1 according to the World Health Organization (WHO), the autoimmune disease affects globally up to 14 million people. RA affects 1 in 28 women and 1 in 59 men during their lifetime. There is no cure for RA; current treatments seek to manage RA with biologic and non-biologic immunosuppressants, corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs). While useful, drug resistance occurs in up to 50% of patients and systemic adverse reactions are frequent, including rash, hair loss, altered liver function, low blood cell counts, nausea, increased infections and neuropathy. New biologics targeting JAK/interleukins have been issued black box warnings by the FDA. According to a market research study, the global anti-rheumatics market is expected to grow from $57.9 billion in 2019 to $62.9 billion in 20272, representing the second largest therapeutic area after oncology. Adalimumab, a biologic blocking TNF which is marketed as Humira®, is #1 among RA therapeutics and also the world’s largest selling drug.
AM-411 provides effective and specific suppression of inflammation in animal arthritis model
AM-411 is a polyplex nanoparticle delivering siRNA to inflamed tissues to target the NF-κB signaling pathway, a critical regulator of immune and inflammatory responses. The drug product is based on Altamira’s OligoPhore technology which allows for delivery of RNA payloads specifically to inflamed tissues with extensive endosomal release once inside cells, generating a new class of precision medicines with increased local efficacy and reduced systemic side effects. AM-411 comprises an optimized siRNA targeting p65, one of the main transcriptional regulators of the NF-kB pathway and a key checkpoint in RA inflammation that has generated high interest as a target. However, given NF-kB’s ubiquitous functions, the key challenge is to induce contextual, tissue specific effects, which is not possible with classic small molecule or biologic approaches. AM-411 reduces local inflammation without affecting the NF-κB pathway elsewhere and is less likely to generate resistance because it reduces synthesis of p65 rather than blocking the protein.
AM-411’s promising therapeutic potential in RA has already been demonstrated in a study using a collagen antibody–induced arthritis model in mice, where OligoPhore nanoparticles with siRNA targeting NF-κB (p65) potently suppressed early inflammatory arthritis.3 The treatment effectively reduced the expression of inflammatory cytokines and cellular influx into the joints, protected against bone erosions and preserved cartilage integrity. Importantly, the treatment did not affect p65 expression in off-target organs or elicit a humoral response after serial injections.
OligoPhore is a versatile platform for safe and effective delivery of siRNA (short 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. OligoPhore 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 Altamira Therapeutics
Altamira Therapeutics (NASDAQ:CYTO) 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 allergens and, where approved, viruses (Bentrio™; commercial) or for 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). Founded in 2003, it is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
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 Altamira Therapeutics’ 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, Altamira Therapeutics’ 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 Altamira Therapeutics’ product candidates, the clinical utility of Altamira Therapeutics’ product candidates, the timing or likelihood of regulatory filings and approvals, Altamira Therapeutics’ intellectual property position and Altamira Therapeutics’ financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira Therapeutics’ 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 Altamira Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2021, and in Altamira Therapeutics’ 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 Altamira Therapeutics or to persons acting on behalf of Altamira Therapeutics 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 Altamira Therapeutics 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.
1 Hunter TM et al. (2017), Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, Rheumatol Int 37(9):1551-57.
2 Allied Market Research.
3 Zhou et al. (2014), Peptide-siRNA nanocomplexes targeting NF-κB subunit p65 suppress nascent experimental arthritis, J Clin Invest 124(10):4363-74.