Gates Package — page 66

e@ =March 2012 --JPM-TMI (DoD) began funding to Medivector (Boston, MA) for development of Favipiravir (T-705) for influenza infection; project is in Phase 3 clinical studies © Approximately 32,000 influenza treatment courses available for purchase from Medivector o DoD has recently awarded contracts for domestic manufacturing but has not initiated manufacturing e July 2014 -- DoD showed the initial evaluation of this drug in Ebola-infected non-human primates had no efficacy; however suboptimal dosing may have occurred. e September 2014 -- DoD will evaluate drug again in Ebola-infected in non-human primates at higher dose to determine efficacy e October 2014-If non-human primate studies are successful, then Medivector will request FDA to determine if clinical bridging study(s) will be required for Ebola infections. VACCINES: Vaccine Research Center (VRC) and GSK -- Adenovirus-vector Ebola vaccine e 2009 - NIAID/VRC started early development of their chimp Ad3 Ebola vaccine e August 2014 - NIAID/VRC will submit an IND to FDA for their vaccine candidate e September 2014 - NIAID will conduct a dose-ranging safety Phase 1 clinical study in the U.S. in healthy adults in e January 2015 - NIAID will conduct a Phase1/2 safety and immunogenicity study in neighboring countries of those West African countries with Ebola outbreaks --NIAID/VRC will work GlaxoSmithKline to optimize and scale up manufacturing of the vaccine candidate in 2014-2015 Newlink Genetics and Public Health Agency Canada (PHAC) - Recombinant Vesicular Stomatitis Virus (rVSVAG) Ebola Vaccine e August 7, 2014 - DoD/DTRA awarded contract to PHAC and Newlink Genetics (Ames, IA) for development of a rVSV Ebola AG vaccine, which PHAC began developing in 2006 @ GMP material was produced at IDT in Germany e August 2014 -- PHAC indicated they had 1400 doses of vaccine on hand o 10 doses were sent to University of Geneva o 1400 doses at PHAC = 600 reserved for non-clinical studies to support Clinical Trial Application (CTA -- USA IND equivalent) and Phase 1 trial = 800 doses available e Anticipated September 2014 0. Preclinical toxicology studies utilizing product from PHAC o Manufacture GMP lot at IDT in Germany to support non-clinical and Phase 1 clinical study e Anticipated January 2015 -- Newlink Genetics will submit IND to FDA.