Soligenix, Inc. announced today significant steps forward in the development of ThermoVax, its proprietary vaccine thermostabilization platform technology. Recent studies have demonstrated the potential for heat-sensitive vaccines formulated using this technology to withstand temperatures exceeding 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The underlying work has been conducted with the company’s proprietary ricin toxin vaccine (RiVax) as part of a continuing program to evaluate the effectiveness of protein subunit vaccines to withstand extremes of temperature and other environmental stress conditions.
These studies amplify and extend former evaluations that indicated retention of potency for at least six months at temperatures as high as 40 degrees Celsius, outside the range of typical vaccine storage conditions. The research and development of ThermoVax is currently being supported by a $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant to Soligenix for biodefense vaccines to prevent ricin toxin and anthrax exposure.
These results underline the potential for long-term stability of subunit vaccines stored under ambient conditions or at high temperatures. Vaccines are almost always stored refrigerated because of vulnerability to heat exposure, resulting in loss of potency and efficacy. By employing ThermoVax during final formulation of RiVax, which is extremely unstable in its liquid form, a stable and potent vaccine is produced that is capable of withstanding temperatures at least as high as 40 degrees Celsius for up to one year. The most recent studies, which employed a combination of sensitive techniques to evaluate the structure of the vaccine and the resulting immunogenicity, demonstrated that the vaccine retained original levels of potency after one year of storage at 40 degrees Celsius. RiVax, formulated with ThermoVax, has the potential to facilitate easier storage and distribution in a national stockpile for emergency situations.
In addition to RiVax, the Company has previously reported that its proprietary anthrax vaccine, VeloThrax, formulated with ThermoVax and subsequently exposed to temperatures as high as 70 degrees Celsius (158 degrees Fahrenheit) for at least one month, retained full potency in animals as well as other characteristics such as receptor binding indicative of full structural integrity. The combination of ThermoVax and VeloThrax along with a potent secondary adjuvant resulted in rapid onset of antibodies correlated to protection against anthrax in animal models. Additional studies have confirmed longer term stability of VeloThrax at 40 degrees Celsius for up to four months.
“The success attained thus far with both ThermoVax formulated RiVax and ThermoVax formulated VeloThrax further demonstrates the robustness and broad applicability of the ThermoVax technology,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We believe that ThermoVax could be applied to a wide variety of vaccines and adjvuants to eliminate the need for refrigeration and cold chain distribution.
Dr. Schaber continued, “We believe ThermoVax is a significant step forward in vaccine technology and has the potential to lead to major cost savings in the distribution and storage of currently marketed vaccines and could further facilitate their use in the developing world. We remain excited about the potential utility of the ThermoVax platform and have initiated discussions with a number of vaccine companies and non-profit organizations regarding the potential for collaboration on heat stable versions of their vaccine candidates.”
ThermoVax, RiVax, VeloThrax and OrbeShield are each trademarked by Soligenix.