UH Med Now
UH medical school Ebola vaccine development attracts second corporate partner
(Princeton, NJ – May 28, 2015) – Soligenix, Inc. (OTCQB: SNGX), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today a collaboration agreement with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UH Mānoa ) and Hawaii Biotech, Inc. (HBI) to develop a heat stable subunit Ebola vaccine. Dr. Lehrer, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates. Under the terms of the feasibility agreement, Soligenix will evaluate its proprietary vaccine thermostabilization technology, ThermoVax™, licensed from the University of Colorado, to stabilize components of the vaccine. Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage.ThermoVax™ has been previously demonstrated to enhance thermostability of both ricin (RiVax™) and anthrax (VeloThrax™) subunit vaccines. The initial work on the potential Ebola vaccine will focus on a single protein subunit antigen.
The most advanced Ebola vaccines involve the use of vesicular stomatitis virus (VSV) and adenovirus vectors – live, viral vectors which complicate the manufacturing, stability and storage requirements. Dr. Lehrer’s vaccine is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Dr. Lehrer and HBI, have developed a robust manufacturing process for the required proteins. Application of ThermoVax™ may allow for a product that can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world.
“We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other Ebola vaccines currently in development,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We are continuing to develop ThermoVax™ using RiVax™, our proprietary ricin vaccine, under a recent National Institute of Allergy and Infectious Diseases (NIAID) contract award of up to $24.7M over 6 years. We intend to apply this same technology beyond biodefense to emerging infectious diseases and see this collaboration with UH Manoa and HBI to be an important next step in demonstrating the broad applicability of this technology.”
The Ebola outbreak in 2014 primarily spanned three West African countries, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of 10,892 people as of May 1, 2015 according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States. The widespread nature of the infection and its devastating impact has further illustrated the need to develop an Ebola vaccine to prevent future and possibly more significant outbreaks.
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™ and VeloThrax™ are extremely labile in their 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 a cooperative grant from NIAID.
About John A. Burns School of Medicine, University of Hawaiʻi at Mānoa
About Hawaii Biotech, Inc.
About Soligenix, Inc.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis. 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.