Sarepta Therapeutics, Tekmira, U.S. Department of Defense infectious, drug delivery news

The DoD will continue funding only Tekmira's Ebola medical countermeasure R&D contract after its and Sarepta's contracts were suspended in August due to government budget constraints. The government selected the TKM-Ebola program from Tekmira, which in 2010 received a contract worth up to $140 million by the DoD's Transformational Medical Technologies (TMT) program to advance an RNAi therapeutic utilizing Tekmira's lipid nanoparticle (LNP) technology, formerly stable nucleic acid-lipid particle (SNALP) technology. Sarepta said its 2010 contract from DoD's TMT program for AVI-7537 was terminated due to funding constraints. Sarepta said the termination does not apply to AVI-7288, which is being developed to treat Marburg virus under the same contract (see BioCentury, Aug. 13 & Sept. 10).

TKM-Ebola is an LNP-formulated combination of short interfering RNAs targeting Zaire Ebola L polymerase, Zaire Ebola membrane-associated protein ( VP24) and Zaire Ebola polymerase complex protein ( VP35). The program is being developed under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. AVI-7537 and AVI-7288 are single oligomer nucleic acid analogs based on morpholino-modified phosphorodiamidate oligomers (PMO) antisense chemistry. Earlier this year Sarepta, completed Phase I single ascending-dose studies for both compounds. ...