Soligenix, Inc. last week announced that it has been granted a U.S. patent for its Thermovax vaccine thermostabilization technology entitled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition”.
The company, which is focused on developing products to treat inflammatory diseases and biodefense countermeasures, says the patent claims encompass composition of matter and methods for the ThermoVax technology, which is exclusively licensed to Soligenix by the University of Colorado.
ThermoVax is a novel method of rendering aluminum salt (alum) adjuvanted vaccines stable at elevated temperatures. Alum is the most widely employed adjuvant technology in the vaccine industry. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, Soligenix says that the use of ThermoVax can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.
ThermoVax was developed specifically to overcome the problems that are encountered with freeze-drying vaccines that contain aluminum adjuvants while simultaneously engineering them to withstand extremes of temperature.
“We expect that the introduction of an effective technology for long-term stabilization of vaccines has the potential to be a major advance in the national effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens,” said Christopher J. Schaber, Soligenix President and CEO.
Elimination of the cold chain could also further facilitate the use of vaccines in parts of the world with less reliable infrastructure.
Development of the technology was supported by a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of thermostable ricin (RiVax) and anthrax (VeloThrax) vaccines.
Proof-of-concept preclinical studies with ThermoVax indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with the company’s aluminum-adjuvanted ricin toxin vaccine, RiVax, made under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the ricin A chain, the immunogenic compound of the vaccine.
When kept at 40 degrees Celsius for six months, all of the animals vaccinated with the lyophilized RiVax vaccine developed potent and high titer neutralizing antibodies. Confirmatory results have extended the stability to six months when the vaccine is kept at 40 degrees Celsius.