Altamira Therapeutics Ltd. announced that it has filed a provisional patent application with the United States Patent Office (USPTO) which covers nanoparticles comprising the Company's OligoPhore?? platform and siRNA targeting the p65 protein, a component of the NF-kB transcription factor. The provisional patent application describes novel nanoparticle compositions based on OligoPhore, Altamira's peptide-based oligonucleotide delivery platform, or derivatives thereof in combination with siRNA sequences designed to silence p65.

Activation of p65 has been observed in multiple types of cancer as well as in many inflammatory diseases and its function has been implicated in the pathogenesis of these diseases. For instance, p65 is a well-known key checkpoint in rheumatoid arthritis (RA) inflammation, and thought to regulate cell proliferation, cell death, and stimulate metastasis in cancer. The new filing is intended to extend Altamira's intellectual property related to its AM-411 development program for RA treatment, among others.

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; 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 2027, representing the second largest therapeutic area after oncology. Effective and specific suppression of inflammation in animal arthritis model AM-411's therapeutic potential in RA was demonstrated in a study using a collagen antibody-induced arthritis model in mice, where OligoPhore nanoparticles with siRNA targeting NF-kB (p65) potently suppressed early inflammatory arthritis.1 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.

Positive outcomes of NF-kB knock-down also in cancer animal models: In cancer, treatment with OligoPhore nanop articles delivering p65 siRNA showed positive outcomes in animal models of melanoma lung metastasis and of Adult T-cell Leukemia Lymphoma (ATLL). Three- serial i.v. injections of nanoparticles of nanoparticles retarded growth of lung metastasis within one week by 76% (p=0.003) as compared to saline control treatments. In the second study, tumor size was significantly lower in treated mice compared to controls, tumor growth was reduced to near zero in the most aggressive tumors and late-stage ATLL tumors were sensitized to conventional chemotherapy.