Tekmira Pharmaceuticals Corporation leading developer of RNA interference (RNAi) therapeutics, announced that the United States Patent & Trademark Office (USPTO) and the European Patent Office (EPO) have issued key patents covering elements of Tekmira’s leading lipid nanoparticle (LNP) technology, which is used to deliver nucleic acid therapeutics, including small interfering RNA (siRNA).
The EPO has granted claims (European Patent No. 1 519 714 B1) covering Tekmira’s proprietary manufacturing process and apparatus for the production of lipid nanoparticles. Tekmira’s manufacturing process is a proprietary method that is robust, scalable and highly reproducible. This process has been reviewed by multiple international regulatory agencies for the production of LNPs used in several ongoing human clinical trials. Tekmira generates revenue by providing manufacturing services to its collaboration partners, including Alnylam Pharmaceuticals, Inc, Bristol-Myers Squibb, Takeda, the United States Government’s Transformational Medical Technologies program and other undisclosed pharmaceutical and biotechnology companies.
The USPTO has granted claims (U.S. Patent No. 7,807,815) covering the identification and modification of siRNA sequence motifs responsible for immune stimulation. This case is the first in a series of Tekmira patent filings covering methods of mitigating siRNA immune stimulation through chemical modification. This intellectual property is based on research by Tekmira scientists on the sequence-dependent stimulation of the innate immune response by nucleic acids, including siRNA.
Dr. Mark J. Murray, Tekmira’s President and CEO, said, “These patents cover important elements of our LNP technology, which is recognized as the gold standard in the systemic delivery of siRNA, and further strengthens our dominant position in nucleic acid delivery. The patents cover our proprietary manufacturing process, which supports our ability to advance our own drug development pipeline while also supporting our partners as they advance their programs. In all, these patents increase the depth, breadth and strength of Tekmira’s intellectual property foundation, ensuring the company is well positioned to secure new research collaborations and business relationships, grow and diversify its sources of revenue, and create and deliver value for shareholders.”
RNAi therapeutics has the potential to treat a broad number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as “siRNAs,” requires delivery technology to be effective systemically. LNP technology is one of the most widely used siRNA delivery approaches for systemic administration. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nano-particles which are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners.