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New partner, new patent
PRINCETON, N.J.—Soligenix Inc., a clinical stage biopharmaceutical company, will jointly develop a treatment for Melioidosis through a worldwide exclusive collaboration with Intrexon, a synthetic biology company. Soligenix intends to develop and commercialize human monoclonal antibody therapies for new biodefense and infectious disease applications for Melioidosis using Intrexon 's advanced human antibody discovery, isolation and production technologies. Soligenix's newly patented ThermoVax heat stabilization technology will be used to avoid problems associated with cold-chain vaccine storage and distribution.
Melioidosis is an often-lethal disease that is endemic in Southeast Asia and Northern Australia. It is also considered a high-priority biodefense threat as defined in the 2012 Public Health Emergency Medical Countermeasures Enterprise Strategy established by the U.S. Department of Health and Human Services with the potential for widespread dissemination through aerosol. The disease is caused by Burkholderia pseudomallei, a Gram-negative bacteria that is highly resistant to antibiotic treatment regimens. In many parts of Southeast Asia, mortality rates are as high as 40 percent, making Melioidosis the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.
Under the agreement, Intrexon will provide discovery and development of therapeutic antibody candidates, as well as optimize and expand production of human monoclonal antibodies targeting Melioidosis. Soligenix will undertake preclinical and clinical development, regulatory and government interactions, as well as the commercialization of therapeutic products. In addition, Soligenix will issue to Intrexon 1,034,483 shares of its common stock, representing 8.5 percent of Soligenix's issued and outstanding shares. Intrexon will also be granted the right to participate in securities offerings that may be conducted by Soligenix in the future as well as the right to make purchases of Soligenix's common stock in the open market.
Dr. Christopher J. Schaber, president and CEO of Soligenix, believes the collaboration is unique because the goal is to develop a therapy that will treat both a deadly disease currently affecting millions of people as well as fight a potential biological weapon.
"Our collaboration with Intrexon is consistent with our corporate strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Soligenix's mission of delivering disease-modifying therapies in areas of high unmet medical need," Schaber says.
Through its BioDefense Division, Soligenix is developing countermeasures pursuant to the Biomedical Advanced Research and Development Authority Strategic Plan of 2011-2016 for inclusion in the U.S. government's Strategic National Stockpile. Soligenix's lead 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. Both vaccines are currently the subject of a $9.4-million National Institute of Allergy and Infectious Diseases grant supporting development of Soligenix's new ThermoVax vaccine heat stabilization technology, for which the company was granted a patent last month. 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 program 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," states Schaber. "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."
Soligenix has 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, Schaber adds.