Altamira Therapeutics Files Provisional Patent Application for OligoPhore Nanoparticles Targeting Different KRAS Mutations in Cancer Treatment

Rhea-AI Summary

Altamira Therapeutics Ltd. (NASDAQ:CYTO) has filed a provisional patent application for a polyvalent siRNA targeting various KRAS mutations, crucial for advanced cancer therapies. This innovation stems from their OligoPhore™ delivery platform, aimed at enhancing RNA therapeutics' effectiveness. The global market for KRAS inhibitors is projected to exceed $4 billion by 2029, with significant prevalence in cancers like colorectal and pancreatic. Altamira's approach is believed to reduce resistance compared to traditional methods. The company plans to pursue an Investigational New Drug (IND) application with the FDA by late 2023.

Positive

• Provisional patent application filed to cover multiple KRAS mutations, enhancing IP portfolio.
• Projected global market for KRAS inhibitors expected to surpass $4 billion by 2029.
• Demonstrated efficient uptake and tumor inhibition in vivo with AM-401 nanoparticles.

Negative

• None.

HAMILTON, BERMUDA, Feb. 27, 2023 (GLOBE NEWSWIRE) --

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• Altamira’s ability to target different KRAS mutations with a single polyvalent siRNA sequence illustrates versatility and potential of RNA therapeutics compared with conventional small molecule approaches
• Analysts project global market for KRAS inhibitors to be more than $4B by 2029

Altamira Therapeutics Ltd. (Nasdaq:CYTO), a company developing RNA-based therapeutics that address important unmet medical needs, today announced that it has filed a 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.

The provisional patent describes novel nanoparticle compositions based on OligoPhore, Altamira’s peptide-based oligonucleotide delivery platform or derivatives thereof, in combination with one siRNA (small interfering ribonucleic acid) sequence designed to silence KRAS. In contrast to small molecule inhibitors, that are designed to inhibit KRAS harboring one specific mutation, Altamira’s approach, polyKRAS^mut, is polyvalent as it allows for silencing KRAS carrying any of the most abundant mutations described for this oncogene. The new filing is intended to expand Altamira’s intellectual property related to its AM-401 development program for the treatment of KRAS-driven cancers.

The KRAS gene encodes the RAS protein which controls - 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.

COO Covadonga Pañeda’s Commentary

“The ability to target different KRAS mutations with one polyvalent siRNA sequence illustrates the great versatility and potential of RNA therapeutics compared to classic small molecule approaches,” stated Covadonga Pañeda, Ph.D., Altamira Therapeutics’ Chief Operating Officer. “In addition, the use of siRNA is expected to elicit less treatment resistance than the direct inhibition exerted by small molecules, which is of particular importance in cancer treatment. However, even the most effective RNA therapeutics are useless if they cannot be delivered to their target, the cancer cell. By combining the polyKRAS^mut siRNA with our OligoPhore technology to form the AM-401 nanoparticles, we can get it delivered precisely where it is required. We’re excited to advance our AM-401 program to provide clinicians and patients with a treatment option that is not limited to just one particular KRAS mutation.”   

The strategy behind AM-401 has already been tested in vitro and in vivo where it 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.¹ 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 late 2023.

There exist more than a dozen different KRAS mutations, but the prevalence of mutation is exceedingly variable among different types of cancers. Mutated forms of KRAS are found in one-fifth of all human cancers, including 32% of non-small-cell lung cancers (NSCLCs), 40% of colorectal cancers (CRCs) and 85–90% of pancreatic cancers. According to the American Cancer Society, overall, almost 150,000 new cases of KRAS-mutated tumors are diagnosed in the United States alone across just these three tumors types each year. It has been estimated that mutations in KRAS alone account for approximately one million deaths per year worldwide.²  Analysts project the global market for KRAS inhibitors to grow from virtually zero in 2021 to more than $4 billion by 2029.³ 

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 OligoPhore™

OligoPhore is a versatile platform designed to enable 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 target tissues other 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 ten 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 Altamira Therapeutics

Altamira Therapeutics (NASDAQ:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic targets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies.

In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection with its Bentrio® OTC nasal spray (commercial stage); and with inner ear therapeutics drugs AM-125 nasal spray for vertigo (post Phase 2), and 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 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 success of the continued commercialization of Bentrio and success of strategic transactions, including licensing or partnering, with respect to Bentrio or any other legacy assets, 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.

FAQ

What is Altamira Therapeutics' recent patent filing about?

Altamira has filed a provisional patent application for a polyvalent siRNA targeting various KRAS mutations to enhance cancer treatment.

What market growth do analysts expect for KRAS inhibitors?

Analysts project the global market for KRAS inhibitors to exceed $4 billion by 2029.

When does Altamira plan to file for an IND application?

Altamira intends to file for an Investigational New Drug (IND) application with the FDA by late 2023.

What benefits does the OligoPhore™ platform offer?

The OligoPhore™ platform enhances the delivery of RNA therapeutics, potentially reducing treatment resistance.

How prevalent are KRAS mutations in cancers?

KRAS mutations are found in approximately 20% of all human cancers, including significant rates in colorectal and pancreatic cancers.