Timothy R Fouts
Profectus Bio-Sciences, USA
Title: Preclinical development of HeV-sG as a vaccine and m102.4 as a post exposure prophylaxis against henipavirus infections
Biography
Biography: Timothy R Fouts
Abstract
Henipaviruses, Nipah virus (NiV) and Hendra virus (HeV) are enveloped negative-sense RNA viruses causing fatal diseases in a variety of animal hosts and in humans. They are listed as Category C biothreat agents by the NIH and CDC and Overlap Select Agents by HHS and USDA. There is no approved human vaccine or therapeutic against either virus. NiV morbidity and mortality matches those of Ebola virus – incubation period 1-3 weeks, 40 to 90% mortality in 2-7 weeks, with evidence of human to human transmission. No human to human transmission were recorded with HeV, however, survivors developed relapsed encephalitis up to 2 years after the disease. In collaboration with Chris Broder of USUHS and Tom Geisbert, UTMB, we are developing HeV-sG, the ectodomain of HeV attachment glycoprotein, as a human vaccine and m102.4, an antiviral antibody, for post-exposure prophylaxis. A HeV-sG based vaccine protected cats, ferrets, African green monkeys and horses from lethal challenges with either HeV or NiV. M102.4 has shown complete post-exposure protection against either HeV or NiV challenge in ferrets and AGMs. Master Cell Banks (MCB) and toxicology lots for each of HeV-sG and m102.4 were prepared. A GLP toxicology study in rats confirmed that m102.4 is safe for Phase 1 clinical studies. AGLP toxicology study in rabbits for HeV-sG will be executed in 2015. Animal efficacy studies with m102.4 showed 100% protection of AGMs against NiV and over 75% protection against HeV. Animal efficacy studies for HeV-sG/Alum formulation are ongoing. Preliminary data showed protection of AGMs after 2 doses with 100ugHeV-sG/Alum.
