Scope and Funding of Contract Expanded to Include New, More Potent LNP Formulation
VANCOUVER, Canada I May 8, 2013 I Tekmira Pharmaceuticals Corporation (TKMR) (TKM.TO), a leading developer of RNA interference (RNAi) therapeutics, today announced that its contract with the U.S. Department of Defense (DoD) has been modified to support development plans that integrate advancements in Tekmira’s lipid nanoparticle (LNP) formulation and manufacturing technologies, and provide for additional funding for the TKM-Ebola program.
TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. DoD’s Joint Project Manager Transformational Medical Technologies (JPM-TMT) Office with a total contract value of approximately $140 million.
“We are pleased that since the initiation of the program in July 2010, our productive collaboration with the JPM-TMT has expanded to include significant advances in LNP formulation technology. The TKM-Ebola program will now incorporate an LNP formulation that is more than 10 times as potent as the previous formulation, and the most potent of all the LNP formulations evaluated in clinical trials. Many of Tekmira’s LNP technology innovations around process development, manufacturing scale-up, and lyophilization have been supported by JPM-TMT,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
Under the modification to the existing contract, funding has been increased by $6.9 million, from $34.8 million to $41.7 million for the first phase of the contract. The modification to the existing contract allows for the integration of a more potent LNP formulation in the TKM-Ebola program as well as advancements in manufacturing technology, including lyophilization. Tekmira has initiated pre-clinical, chemistry, manufacturing and control studies that support the use of these improvements in the program. Tekmira anticipates the completion of these studies and a submission to the FDA in the second half of 2013 in order to support the use of the enhanced product in a Phase I clinical trial. New data from the TKM-Ebola program will be presented at the 15th Annual TIDES Summit: Oligonucleotide and Peptide(R) Therapeutics from Research through Commercialization taking place in Boston, MA from May 12-15, 2013.
About JPM-TMT
JPM-TMT is a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). JPM-TMT aims to protect the Warfighter from emerging infectious diseases, genetically altered, and unknown biological threats. Through strategic investments and partnerships with innovative biotech firms, pharmaceutical corporations, other government agencies, and academic institutions, JPM-TMT facilitates the advanced development and acquisition of adaptable platform technologies, broad-spectrum medical countermeasures, and innovative systems to enhance our nation’s biodefense response capability. For more information, visit www.jpmtmt.mil.
About RNAi and Tekmira’s LNP
RNAi therapeutics have 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,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that 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.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
SOURCE: Tekmira
Post Views: 568
Scope and Funding of Contract Expanded to Include New, More Potent LNP Formulation
VANCOUVER, Canada I May 8, 2013 I Tekmira Pharmaceuticals Corporation (TKMR) (TKM.TO), a leading developer of RNA interference (RNAi) therapeutics, today announced that its contract with the U.S. Department of Defense (DoD) has been modified to support development plans that integrate advancements in Tekmira’s lipid nanoparticle (LNP) formulation and manufacturing technologies, and provide for additional funding for the TKM-Ebola program.
TKM-Ebola, an anti-Ebola viral therapeutic, is being developed under a contract with the U.S. DoD’s Joint Project Manager Transformational Medical Technologies (JPM-TMT) Office with a total contract value of approximately $140 million.
“We are pleased that since the initiation of the program in July 2010, our productive collaboration with the JPM-TMT has expanded to include significant advances in LNP formulation technology. The TKM-Ebola program will now incorporate an LNP formulation that is more than 10 times as potent as the previous formulation, and the most potent of all the LNP formulations evaluated in clinical trials. Many of Tekmira’s LNP technology innovations around process development, manufacturing scale-up, and lyophilization have been supported by JPM-TMT,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
Under the modification to the existing contract, funding has been increased by $6.9 million, from $34.8 million to $41.7 million for the first phase of the contract. The modification to the existing contract allows for the integration of a more potent LNP formulation in the TKM-Ebola program as well as advancements in manufacturing technology, including lyophilization. Tekmira has initiated pre-clinical, chemistry, manufacturing and control studies that support the use of these improvements in the program. Tekmira anticipates the completion of these studies and a submission to the FDA in the second half of 2013 in order to support the use of the enhanced product in a Phase I clinical trial. New data from the TKM-Ebola program will be presented at the 15th Annual TIDES Summit: Oligonucleotide and Peptide(R) Therapeutics from Research through Commercialization taking place in Boston, MA from May 12-15, 2013.
About JPM-TMT
JPM-TMT is a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). JPM-TMT aims to protect the Warfighter from emerging infectious diseases, genetically altered, and unknown biological threats. Through strategic investments and partnerships with innovative biotech firms, pharmaceutical corporations, other government agencies, and academic institutions, JPM-TMT facilitates the advanced development and acquisition of adaptable platform technologies, broad-spectrum medical countermeasures, and innovative systems to enhance our nation’s biodefense response capability. For more information, visit www.jpmtmt.mil.
About RNAi and Tekmira’s LNP
RNAi therapeutics have 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,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that 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.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
SOURCE: Tekmira
Post Views: 568
