The US Patent and Trademark Office (USPTO) granted patent 8,444,991 entitled "Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition," to Soligenix, Inc. The new patent's claims encompass composition of matter and method claims for ThermoVax, the vaccine thermostabilization technology exclusively licensed to Soligenix by the University of Colorado.
The main patent claims describe methods of preparing an immunologically-active adjuvant-bound, thermostable, freeze dried vaccine composition in which the vaccine utilizes conventional adjuvants comprised of aluminum salts, as well as claims covering the adjuvant-bound composition itself. 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 granting of the thermostabilization patent is a significant milestone for the ThermoVax programme and is a critical component in our commercialization strategy for vaccines that can avoid the increased costs and logistical burdens associated with cold chain storage and distribution," stated Christopher J Schaber , 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 national effort to develop effective countermeasures and therapies for significant biothreats and emerging pathogens. We 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, is a novel method of rendering aluminum salt (known colloquially as Alum), adjuvanted vaccines stable at elevated temperatures. Alum is the most widely employed adjuvant technology in the vaccine industry. The value of ThermoVax lies in its potential ability to eliminate the need for cold-chain production, transportation, and storage for Alum adjuvanted vaccines. This would relieve companies of the high costs of producing and maintaining vaccines under refrigerated conditions. Based on historical reports from the World Health Organization and other scientific reports, a meaningful proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due to the fact that most aluminum adjuvanted vaccines need to be maintained at between 2 and 8 degrees Celsius and even brief excursions from this temperature range (especially below freezing) usually necessitates the destruction of the product or the initiation of costly stability programmes specific for the vaccine lots in question. The savings realized from the elimination of cold chain costs and related product losses would in turn significantly increase the profitability of vaccine products. Elimination of the cold chain would also further facilitate the use of these vaccines in the lesser developed parts of the world. ThermoVax has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency settings.
Soligenix is a clinical stage biopharmaceutical company developing products to treat serious gastrointestinal diseases where there remains an unmet medical need, as well as developing several biodefense vaccines and therapeutics.