PRINCETON, NJ – Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced in a press release that the US Patent and Trademark Office (USPTO) granted patent 8,808,710 entitled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition.”  The newly issued patent claims cover compositions and methods for manufacturing vaccines utilizing ThermoVax™, the Company’s proprietary vaccine thermostabilization technology. 

 

The new patent complements US patent 8,444,991, granted on May 21, 2013, that primarily included claims for methods of making stabilized vaccines.  In the new patent, the main patent claims describe compositions of immunologically-active adjuvant-bound, thermostable, freeze-dried vaccines in which the vaccine utilizes conventional adjuvants comprised of aluminum salts.  Aluminum salts are commonly used as adjuvants in many vaccines, including those administered to children. 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. 

 

“The newly issued patent is another milestone in the development of stabilized vaccines using ThermoVax™.  This patent is a critical component in our commercialization strategy for vaccines, by creating vaccines that avoid the costs and logistical burdens associated with cold chain storage and distribution,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “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 worldwide effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens. We continue to pursue a number of vaccine companies and non-profit organizations regarding the potential for collaboration on heat stable versions of their vaccine candidates.”

 

ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines.  Cold chain requirements add considerable cost to the production and storage of current conventional vaccines.  According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain.  Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities.  Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges.  NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production.  For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.