Tekmira Pharmaceuticals Corporation, 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® Therapeutics from Research through Commercialization taking place in Boston, MA from May 12-15, 2013.