SOURCE: Marina Biotech, Inc.

Marina Biotech, Inc.

September 11, 2014 07:30 ET

Marina Biotech Announces the Continued Worldwide Expansion of Its Delivery Technology Intellectual Property Estate

Patents Covering the Company's SMARTICLES®, tkRNAi, DILA2 and Lipopeptide Delivery Technologies Are Granted in Europe, Japan, Australia and China, Respectively

BOSTON, MA--(Marketwired - Sep 11, 2014) - Marina Biotech, Inc. (PINKSHEETS: MRNA), a leading nucleic acid-based drug discovery and development company focused on rare diseases, announced today that it had received patent protection for its comprehensive and diverse nucleic acid delivery platform with patent grants covering the following delivery technologies: SMARTICLES® in Europe; TransKingdom RNA™ interference (tkRNAi) in Japan; Di-terminal Amino Acid Lipids (DILA2) in Australia; and lipopeptide nucleic acid delivery in China. These grants support a global intellectual property estate broadly covering the Company's biochemistry and delivery technologies with over 100 issued or allowed patents and over 90 pending U.S. and foreign patent applications.

"Marina Biotech continues to extend patent coverage for its nucleic acid delivery technologies in key commercial markets," stated J. Michael French, president & CEO of Marina Biotech. "Looking broadly at our nucleic acid delivery capability, we believe we are the only company that has a delivery technology, SMARTICLES, in clinical development that is: (1) delivering both a single-stranded and double-stranded nucleic acid; (2) delivering to both the cell nucleus (ProNAi Therapeutics' single-stranded DNA decoy) and cell cytoplasm (Mirna Therapeutics' double-stranded microRNA mimic); and (3) delivering a lipid nanoparticle outside the liver, (i.e. tumors). Further, we believe we are the only company that has two separate and distinct delivery technologies, SMARTICLES (lipid nanoparticle) and tkRNAi (engineered bacteria), in clinical development. Finally, we are the only company with an orally administered RNAi-based therapeutic in clinical development - the Company's CEQ508 for the treatment of Familial Adenomatous Polyposis. Taken in its entirety, we believe our delivery platform is unparalleled within the sector and unequalled in clinical versatility. We expect these technologies to be instrumental in the rapid advancement of nucleic acid therapeutics treating rare diseases."

SMARTICLES® (Europe)
SMARTICLES are amphoteric liposomes composed of unique combinations of anionic and cationic lipids that work together to enable cell uptake and to provide serum stability and pH-triggered endosomal escape. SMARTICLES is the only technology delivering both single-stranded (PNT2258) and double-stranded (MRX34) nucleic acid payload in ongoing clinical trials conducted by licensees, ProNAi Therapeutics and Mirna Therapeutics, respectively.

The claims of Marina Biotech's patent for licensed SMARTICLES delivery technology in Europe (Ser. No. 10734065.5) cover delivery technology based on SMARTICLES amphoteric liposomes adapted for the release of therapeutic cargos, including the Company's RNA-based therapeutics having conformationally restricted nucleotides (CRN).

TransKingdom RNA™ interference (Japan)
tkRNAi are non-pathogenic bacteria engineered to produce, deliver, and release to targeted tissue various therapeutic molecules including interfering RNA mediators, such as short hairpin RNA and microRNA mimics, as well as other therapeutics. Marina Biotech's tkRNAi technology includes CEQ508, the only orally administered nucleic acid therapeutic in clinical development. CEQ508 has been orally administered in two cohorts of a four cohort dose-escalating study in a Phase 1 human clinical trial in Familial Adenomatous Polyposis (FAP) patients. The Company has received U.S. Food and Drug Administration Orphan Drug Designation for this program.

The claims of Marina Biotech's patent for tkRNAi delivery technology in Japan (Ser. No. 2007-546917) cover a wide range of compositions for bacterial mediated gene silencing, as well as the fundamental invasive bacterium for delivering RNA therapeutics. The patent issuance in Japan will expand the international coverage of this technology, which includes related patents granted in Europe, Korea, Australia and Canada. 

Di-terminal Amino Acid Lipids (Australia)
DILA2 are proprietary molecules composed of unique combinations of head groups and terminal groups on a central amino acid having unique cone angles for formation of small, cargo-carrying liposomes. DILA2 technology is designed to improve a variety of delivery characteristics including encapsulation of nanoparticles, cellular uptake, endosomal release, and cell/tissue targeting.

The claims of Marina Biotech's National Stage Application for DILA2 liposomal delivery technology in Australia (Ser. No. 2008247488) broadly cover DILA2 compounds, as well as compositions containing therapeutic nucleic acids, and uses for delivering drugs to cells, tissues, organs, and subjects having a wide range of diseases. The patent claims granted in Australia cover norarginine-based DiLA2 compounds, which are known to be some of the most efficacious liposome-forming compounds developed by Marina Biotech for delivery of nucleic acid-based therapeutics. 

Lipopeptide nucleic acid delivery (China)
Marina Biotech's proprietary lipopeptide delivery formulations encompass a novel lipopeptide structure with multiple attachment points that is designed to capture and bind anionic agent while allowing for the release of the agents in the cellular uptake process. In that sense, the lipopeptide formulations reflect a universal delivery technology for nucleic acid-based therapeutics.

The claims of Marina Biotech's patent for lipopeptide delivery technology in China (Ser. No. 200880110140.7) cover delivery technology based on lipopeptides that were developed by Marina Biotech for delivery of nucleic acid-based therapeutics. The granted claims cover lipopeptide formulations that are suitable for carrying and releasing therapeutic cargos such as the company's RNA-based drug candidates having conformationally restricted nucleotides (CRN), as well as other RNA and DNA-based therapeutics.

About Marina Biotech, Inc.
Marina Biotech is an oligonucleotide therapeutics company with broad drug discovery technologies providing the ability to develop proprietary single and double-stranded nucleic acid therapeutics including siRNAs, microRNA mimics, antagomirs, and antisense compounds, including messengerRNA therapeutics. These technologies were built via a roll-up strategy to discover and develop different types of nucleic acid therapeutics in order to modulate (up or down) a specific protein(s) which is either being produced too much or too little thereby causing a particular disease. We believe that the Marina Biotech technologies have unique strengths as a drug discovery engine for the development of nucleic acid-based therapeutics for rare and orphan diseases. Further, we believe Marina Biotech is the only company in the sector that has a delivery technology in human clinical trials with differentiated classes of payloads, through licensees ProNAi Therapeutics and Mirna Therapeutics, delivering single-stranded and double-stranded nucleic acid payloads, respectively. Our novel chemistries and other delivery technologies have been validated through license agreements with Roche, Novartis, Monsanto, and Tekmira. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and a preclinical program in myotonic dystrophy. Marina Biotech's goal is to improve human health through the development of RNAi- and oligonucleotide-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Additional information about Marina Biotech is available at www.marinabio.com.

Marina Biotech Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to obtain additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (v) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech's most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.

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