Soligenix Announces Issuance of US Patent for ThermoVax™ Technology

New patent includes composition of matter claims

 

PRINCETON, N.J., Sept. 9, 2014 /PRNewswire/ -- Soligenix, Inc. (otcqb:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that the US Patent and Trademark Office (US PTO) 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."

 

About ThermoVax ™

 

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. 

 

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.  RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit).  By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. 

 

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.

 

About Soligenix, Inc.

 

Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Soligenix is developing proprietary formulations of oral BDP (beclomethasone 17,21-dipropionate) for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).  Soligenix is also advancing its novel innate defense regulator (IDR) technology SGX942 for the treatment of oral mucositis and SGX301, its novel first-in-class photodynamic technology utilizing synthetic hypericin with safe visible light, for the treatment of cutaneous T-cell lymphoma.  

 

Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan of 2011-2016 for inclusion in the US government's Strategic National Stockpile. Soligenix's biodefense products in development are a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin and VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Both RiVax™ and VeloThrax™ are currently the subject of a $9.4 million National Institute of Allergy and Infectious Diseases (NIAID) grant supporting development of Soligenix's new vaccine heat stabilization technology known as ThermoVax™.  Soligenix is also developing OrbeShield™ for the treatment of gastrointestinal acute radiation syndrome (GI ARS) under a BARDA contract award valued up to $26.3 million and a NIAID contract award valued up to $6.4 million. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in a canine model of GI ARS funded by NIAID.  Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +3.81% focused on the joint development of a treatment for melioidosis, a high priority biothreat and an area of unmet medical need.

 

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

 

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

 

SOURCE Soligenix, Inc.

 

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