Date: 2016-08-03
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 2016 Workshop on Protein Aggregation and Immunogenicity, on August 2-4, 2016 in Breckenridge, Colorado
Company: Soligenix (USA - NJ) Hawaii Biotech (USA - HI) University of Hawaii (USA - HI)
Product: heat stable subunit Ebola vaccine
Action
mechanism: vaccine. Soligenix' ThermoVax® technology has been applied to stabilize an Ebola subunit vaccine. This technology is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. .
Disease: Ebola fever
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On August 3, 2016, results from the Ebola development studies have been presented by Dr. Carly Chisholm and Dr. Theodore Randolph in a poster entitled "Thermostable Lyophilized Ebola Vaccine Formulations" at the 2016 Workshop on Protein Aggregation and Immunogenicity, on August 2-4, 2016 in Breckenridge, Colorado. The poster describes the use of ThermoVax® to stabilize an Ebola subunit vaccine. Degradation of protein assembly state was observed in incubated liquid formulations, whereas changes in protein assembly state were minimal in incubated lyophilized formulations. In order to better differentiate immune responses between vaccine formulations, * On July 18, 2016, Soligenix announced positive preliminary proof-of-concept results from its collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaii at M?noa (UH M?noa) and Hawaii Biotech, to develop a heat stable subunit Ebola vaccine. Thermostabilization formulation studies, conducted with Theodore Randolph, PhD at the University of Colorado Boulder, have identified a formulation that enhances the physical stability of the protein and may be dose sparing (i.e., allowing immunization to potentially be achieved with fewer vaccinations). Dr. Lehrer, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates. Soligenix evaluated its proprietary vaccine thermostabilization technology, ThermoVax®, licensed from the University of Colorado, to stabilize components of the vaccine. These studies identified a formulation that maintained the physical state of the Ebola subunit protein despite incubation at 40°C for 12 weeks. Moreover, initial testing revealed that two doses of this new formulation is as effective as three doses of a non-stabilized vaccine in generating antibodies to Ebola, even after storage at 40 degrees Celsius for 12 weeks. Further studies evaluating the protective ability of the vaccines are planned. Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage. In preclinical studies, ThermoVax® has been previously demonstrated to enhance thermostability of ricin (RiVax™), anthrax and human papillomavirus (HPV) subunit vaccines. The most advanced Ebola vaccines involve the use of vesicular stomatitis virus (VSV) and adenovirus vectors - live, viral vectors which complicate the manufacturing, stability and storage requirements. Dr. Lehrer's vaccine is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Dr. Lehrer and HBI have developed a robust manufacturing process for the required proteins. Application of ThermoVax® may allow for a product that can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world.
passive protection studies in mice are now being conducted.
