Altamira Therapeutics Files Second Provisional Patent Application for OligoPhore Nanoparticles Targeting Different KRAS Mutations in Cancer Treatment
Altamira Therapeutics Ltd. (Nasdaq: CYTO) has filed a second provisional patent application with the USPTO for its polyKRASmut siRNA, showing a 65-91% knockdown of KRAS mutations in colorectal, non-small cell lung, and pancreatic cancer cell lines. The nanoparticles developed as AM-401 aim to provide broad coverage of different KRAS mutations in human cancer treatment. The data suggests that polyKRASmut siRNA has the potential to knock down other untested mutations, making it a promising treatment for severe types of cancer.
Positive
The polyKRASmut siRNA has been shown to knock down at least 65-91% of KRAS mutations in colorectal, non-small cell lung, and pancreatic cancer cell lines.
The second provisional patent application aims to provide broad coverage of different KRAS mutations in human cancer treatment with nanoparticles developed as AM-401.
The combination of polyKRASmut siRNA with Altamira's OligoPhore platform can direct its delivery to the tumor and tackle many different KRAS mutations, potentially making it a more effective treatment for severe types of cancer.
The recent advancements by Altamira in targeting KRAS mutations with their polyKRASmut siRNA is a significant development in the field of oncology. KRAS mutations are a notorious contributor to the pathogenesis of various cancers, including colorectal, non-small cell lung and pancreatic cancers. The ability to knock down a wide spectrum of these mutations could represent a major therapeutic breakthrough. The in vitro efficacy ranging from 65-91% in knocking down mutations is promising, potentially offering a more comprehensive treatment option compared to existing therapies that target a single mutation. This broad-spectrum approach could be particularly beneficial in addressing tumor heterogeneity and the emergence of resistant cancer cell subpopulations.
Furthermore, the use of Altamira's OligoPhore platform for targeted delivery to the tumor could enhance the specificity of treatment, reducing off-target effects and improving tolerability. This specificity is crucial in reducing the systemic toxicity often associated with cancer treatments. The development of AM-401 nanoparticles also highlights the growing importance of RNA-based therapies in oncology, which may offer advantages over traditional small molecule inhibitors in terms of precision and reduced side effects.
Altamira's filing of a second provisional patent application indicates a strategic move to solidify its intellectual property and competitive position in the biotechnology market. The in vitro data supports the potential for AM-401 to treat multiple KRAS-driven cancers, which could translate into a significant clinical impact given the prevalence of these mutations across various cancer types. The comparison with existing small molecule inhibitors, which are limited to targeting the G12C mutation, underscores the potential for AM-401 to address a larger patient population.
From a research perspective, the robustness of the preclinical data will be critical for advancing AM-401 through the clinical development pipeline. The next steps will likely include further preclinical studies to assess the safety profile and efficacy in vivo, followed by clinical trials to evaluate the therapeutic benefits in patients. The success of these studies will be pivotal in determining the market potential of AM-401 and its impact on Altamira's valuation.
The announcement by Altamira could have a substantial impact on the market for cancer therapeutics, particularly in the niche of KRAS mutation-targeted treatments. Given that current treatments are limited to targeting a single KRAS mutation, the development of a therapy with the capability to address multiple mutations could disrupt the market and capture significant market share. The potential for better tolerability and fewer side effects with AM-401 suggests a favorable competitive advantage, which could influence prescribing patterns and insurance coverage decisions.
Investors and stakeholders should monitor Altamira's progress closely, as successful development and subsequent approval of AM-401 could lead to substantial revenue growth for the company. The long-term implications for Altamira's stock performance hinge on the clinical trial outcomes and the ability to scale production and distribution to meet global demand, should AM-401 prove to be effective and gain regulatory approval.
01/24/2024 - 08:47 AM
HAMILTON, BERMUDA, Jan. 24, 2024 (GLOBE NEWSWIRE) --
Altamira’s poly KRASmut siRNA shown to knock down at least 65-91% of KRAS mutations in colorectal, non-small cell lung, and pancreatic cancer cell lines Fresh experimental data expected to strengthen Altamira’s intellectual property around its AM-401 nanoparticles for the treatment of KRAS-driven cancers HAMILTON, BERMUDA, Jan. 24, 2024 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, today announced that it has filed a second provisional patent application with the United States Patent and Trade Office (USPTO) to provide broad coverage of different KRAS mutations in human cancer treatment with nanoparticles comprising the Company’s OligoPhore™ platform and a single siRNA sequence, poly KRASmut . The nanoparticles are developed by Altamira as AM-401.
The second provisional application contains in vitro data confirming the ability of poly KRASmut siRNA to knock down a broad range of KRAS mutations in cancer cell lines. These mutations include G12C, G12V, G12D, G12R, G12A, and A146T, which account for 90.9% of KRAS mutations reported in pancreatic ductal adenocarcinoma (PDAC), 65.3% in colorectal cancer (CRC) and 80.0% in non-small cell lung cancer (NSCLC).1 In comparison, currently approved small molecule inhibitors target just one KRAS mutation (G12C), which represents 1.7% , 7.1% and 41.0% of total KRAS mutations in PDAC, CRC and NSCLC, respectively. Since poly KRASmut was tested against only a limited number of mutations, it may potentially knock down other, yet untested mutations.
“We are very pleased to observe the latest data on our poly KRASmut siRNA confirming its ability in knocking down several KRAS mutations known to drive some of the most severe types of cancer” commented Covadonga Pañeda, Ph.D., Altamira Therapeutics’ Chief Operating Officer. “By combining the poly KRASmut siRNA with our OligoPhore platform we can direct its delivery to the tumor and tackle with one single compound many different KRAS mutations. This combination aims to not only treat cancers harboring different KRAS mutations but also addresses some of the escape mechanism developed by these tumors that make them less responsive to small molecule KRAS-directed therapies. Additionally, we expect that AM-401 will be better tolerated than small molecule-inhibitors as it specifically targets the tumor-affected organ without affecting healthy tissues. We are excited about advancing our AM-401 program to provide clinicians and patients with a comprehensive treatment option for KRAS-driven cancers.”
Altamira expects the second provisional patent application to further strengthen its intellectual property around the AM-401 program, under which the Company is aiming to develop a treatment for KRAS-driven cancers. Previous in vitro and in vivo work demonstrated efficient uptake of OligoPhore nanoparticles with KRAS-targeted siRNA in CRC and PDAC cells, strong inhibition of KRAS expression, reduced viability of tumor cells, and significant reduction in tumor growth and volume.2 Importantly, a murine model demonstrated the capacity of the OligoPhore platform to drive targeted delivery of the nanoparticles specifically to tumor cells. Altamira intends to file for an Investigational New Drug (IND) application with the FDA in 2025 and to partner the program upon an IND grant or following a phase 1 clinical trial.
The KRAS gene encodes one of the RAS proteins, that control – like an “on / off switch” – cell growth, maturation, migration, and death. Through mutations, the RAS proteins can be rendered persistently active, causing cancer cells to proliferate and spread in the body. Mutations of KRAS are associated with poor prognosis in several cancers, and there is a substantial body of evidence supporting the role of KRAS in the initiation and maintenance of cancer. Mutated forms of KRAS are found in one-fifth of all human cancers, including 32% of NSCLCs, 40% of CRCs and 85–90% of PDACs. According to the American Cancer Society, nearly 150,000 new cases of KRAS-mutated tumors are diagnosed annually in the United States across these three tumor types alone. It is estimated that KRAS mutations account for approximately one million deaths per year worldwide.3
Although the role of KRAS mutations in cancer has been known for decades, they have remained a challenging target for therapeutic interventions. KRAS was long considered undruggable, in part, because of the lack of obvious binding sites. Only recently, the FDA approved the first two treatments for KRAS-driven cancer: sotorasib and adagrasib, two small molecule inhibitors of G12C-mutated KRAS for the treatment of NSCLC.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a 49% stake (with additional economic rights) in its commercial-stage legacy asset Bentrio®, an OTC nasal spray for allergic rhinitis. Further, the Company is in the process of partnering / divesting its inner ear legacy assets (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com
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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Altamira’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 success of strategic transactions, including licensing or partnering, with respect to Altamira’s legacy assets, Altamira’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the clinical utility of Altamira’s product candidates, the timing or likelihood of regulatory filings and approvals, Altamira’s intellectual property position and Altamira’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Altamira’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 Altamira’s Annual Report on Form 20-F for the year ended December 31, 2022, and in Altamira’s other filings with the Securities Exchange Commission (“SEC”), which are available free of charge on the SEC’s website at: www.sec.gov
Contact Hear@altamiratherapeutics.com
1 Based on Huang et al. (2021), KRAS mutation: from undruggable to druggable in cancer, Sig Transduct Target Ther 6: 386. https://doi.org/10.1038/s41392-021-00780-4
2 Strand et al. (2019), Precision delivery of RAS-inhibiting siRNA to KRAS driven cancer via peptide-based nanoparticles, Oncotarget 10(46): 4761-75.
3 Simanshu et al. (2017), RAS proteins and their regulators in human disease, Cell 170(1):17-33.
What is the ticker symbol for Altamira Therapeutics Ltd.?
The ticker symbol for Altamira Therapeutics Ltd. is CYTO.
What is the significance of the second provisional patent application filed by Altamira?
The second provisional patent application aims to provide broad coverage of different KRAS mutations in human cancer treatment with nanoparticles developed as AM-401.
What percentage of KRAS mutations does the polyKRASmut siRNA aim to knock down?
The polyKRASmut siRNA aims to knock down at least 65-91% of KRAS mutations in colorectal, non-small cell lung, and pancreatic cancer cell lines.
What is the potential of polyKRASmut siRNA to knock down untested mutations?
The data suggests that polyKRASmut siRNA has the potential to knock down other untested mutations, making it a promising treatment for severe types of cancer.
Who commented on the latest data of polyKRASmut siRNA?
Covadonga Pañeda, Ph.D., Altamira Therapeutics’ Chief Operating Officer, commented on the latest data of polyKRASmut siRNA.
