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news.Marina Biotech, a leading nucleic acid-based drug discovery and development company focused on rare diseases, has announced that a decision to grant a patent has been issued for the company's SMARTICLES delivery technology in Japan (Ser. No. 2008-530426).
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The claims of this National Stage Application cover delivery technology based on Marina’s proprietary SMARTICLES amphoteric liposomes and directly support the clinical programs of the company’s licensees ProNAi Therapeutics, Inc. and Mirna Therapeutics, Inc.
The granted claims cover amphoteric liposomes that are suitable for tailoring delivery systems for the release of therapeutic cargos, including DNA oligonucleotides, antisense and/or decoy entities, ribozymes, DNAzymes or aptamers, as well as proteins, peptides, and RNA-based drugs such as siRNA and miRNA.
"The decision to grant from the Japan Patent Office further extends the scope of our intellectual property covering our SMARTICLES technology, while the positive clinical delivery experiences of both ProNAi and Mirna provide significant scientific and clinical validation of SMARTICLES," stated J. Michael French, President and CEO of Marina Biotech.
"We believe that SMARTICLES, which is broadly covered by the company’s patent estate, is a leading means for the successful delivery of nucleic acid compounds. Further, we believe it is the only delivery technology in development that has delivered both a single- and a double-stranded oligonucleotide in a clinical setting. We believe that the breadth and flexibility of the SMARTICLES platform provides significant competitive advantages and differentiation as we move forward with our rare disease clinical pipeline."
The claims of this National Stage Application cover delivery technology based on SMARTICLES amphoteric liposomes, which are composed of phosphatidylcholine (PC) and phosphatidylethanolamine (PE), along with chargeable amphiphiles.
The chargeable amphiphiles include at least one pH sensitive anionic lipid and at least one pH sensitive cationic lipid. These amphoteric liposomes impart a unique in vivo serum stability to the delivery formulation. Serum stability is enhanced by synergistically balancing the overall charge of the amphoteric liposomes using the pH sensitive anionic lipids and pH sensitive cationic lipids. The stable amphoteric liposomes can have a particle size of from 50 to 500 nm, and represent a leading technology for delivering therapeutics in the fields of oligonucleotide, decoy and antisense drugs, as well as RNA-based drugs.
A significant aspect of the granted intellectual property is the breadth of the covered technology. For example, the ratio of phosphatidylethanolamine to phosphatidylcholine can be varied over a very wide range from 0.5 to 8. Further, the compositional balance between the PC/PE components and the chargeable amphiphiles can be varied over a wide range from 5% to 95%. These features give SMARTICLES technology an extraordinary flexibility in selection and development of lead formulations for clinical trials.