Soligenix receives Japanese patent

Soligenix, Inc.  (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced 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. ThermoVax is a proprietary vaccine heat stabilization platform technology and the patent, entitled "Thermostable vaccine compositions and methods of preparing same," is also being pursued in other major markets worldwide, such as China, Europe, and the US.

The issued patent 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.

Recent developments in the RiVax program have also described immune correlates of protection for the ricin toxin vaccine, which are important to facilitating potential approval of thermostabilized RiVax via the US Food and Drug Administration (FDA) "Animal Rule". As a biodefense vaccine, RiVax also has the potential to qualify for a priority review voucher (PRV) upon FDA approval. Recent PRVs have sold for as much $350 million.

"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."