Tekmira Signs Manufacturing Pact for Ebola RNAi Drug
Tekmira Pharmaceuticals Corporation, a developer of RNA interference (RNAi) therapeutics, has formed a manufacturing and clinical trial agreement with the University of Oxford to provide a new TKM-Ebola-Guinea therapeutic product, an anti-Ebola virus RNAi therapeutic, for clinical studies in West Africa. The studies are expected to begin early this year, subject to finalization of a suitable clinical protocol.
The University of Oxford is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). ISARIC will conduct clinical studies of TKM-Ebola-Guinea in Ebola virus-infected patients, with funding provided by the Wellcome Trust. GMP manufacture of TKM-Ebola-Guinea is now complete and 100 treatment courses are available for the study.
The Ebola-Guinea strain is the virus responsible for the current outbreak in West Africa. This strain diverges slightly from the Kikwit strain, which was the original target of TKM-Ebola. The genomic sequence of the Ebola-Guinea strain was determined from several viral isolates and published in the New England Journal of Medicine in October 2014. Tekmira developed a modified RNAi therapeutic, based on the company’s original TKM-Ebola investigational therapeutic, to specifically target Ebola-Guinea. The new product, termed TKM-Ebola-Guinea, is designed to match the genomic sequence exactly, with two RNAi triggers.
TKM-Ebola is being developed under a $140 million contract with the US Department of Defense’s Medical Countermeasure Systems BioDefense Therapeutics (JPM-MCS-BDTX) Joint Product Management Office. In March 2014, Tekmira was granted a fast frack designation from the US Food and Drug Administration for the development of TKM-Ebola.