Sarepta Therapeutics, Tekmira, U.S. Department of Defense infectious, drug delivery news
The companies said the DoD extended an August stop-work order for their respective Ebola programs. The companies expect to receive notification from DoD by Sept. 30 on whether it will cancel the stop-work order, terminate the contracts or extend the stop-work order period. The DoD issued stop-work orders to Tekmira and Sarepta last month due to funding constraints (see BioCentury, Aug. 13).
Tekmira is developing TKM-Ebola under a contract awarded 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. 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). Both programs will be 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. ...