Soligenix, Inc. announced today that it has been granted a Japanese patent (number 6110845) further extending protection around ThermoVax including coverage of the company’s ricin toxin vaccine candidate, RiVax.
The technology is designed to eliminate the cold chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.
For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of vaccine stabilization platforms has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.
The issued patent for ThermoVax is complementary to previous patents, including US patents 8,444,991 granted on May 21, 2013 and 8,808,710 granted on August 19, 2014, that include claims for methods of making stabilized vaccines and their attendant compositions. In this new patent, the main claims cover formulations of Soligenix’s proprietary thermostabilized ricin toxin vaccine, RiVax. The thermostable formulation of RiVax has been shown to be stable for at least 12 months at temperatures up to 40 degrees Celsius (104 degrees Fahrenheit) and to provide 100% protection to non-human primates exposed to aerosol ricin challenge.
“ThermoVax has successfully demonstrated that it can thermostabilize a number of different alum-adjuvanted protein antigens, including antigens for ricin, anthrax, human papillomavirus and Ebola,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “The RiVax program continues to progress towards potential approval under the Animal Rule, and as our most advanced product candidate using the ThermoVax technology, it also provides positive proof-of-concept for use of this proprietary heat stabilization platform with other development and commercial vaccines. While we advance RiVax with the support of NIAID contract funding, we also look forward to potentially applying the ThermoVax technology to other vaccine candidates in the future.”
By employing ThermoVax during the final formulation of RiVax, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. Similar stabilization at temperatures as high as 50 degrees Celsius for up to 3 months (maximum timepoint tested) have also been demonstrated with other antigens (e.g., human papillomavirus, Ebola and anthrax).
ThermoVax® with RiVax® are registered, protected terms by Soligenix, Inc.
