New partner, new patent

Soligenix to expand biodefense and infectious disease product pipeline through collaboration with Intrexon

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PRINCETON, N.J.—Soligenix Inc., a clinical stage biopharmaceuticalcompany, will jointly develop a treatment for Melioidosis through a worldwideexclusive collaboration with Intrexon, a synthetic biology company. Soligenixintends to develop and commercialize human monoclonal antibody therapies fornew biodefense and infectious disease applications for Melioidosis usingIntrexon's advanced human antibody discovery, isolation and productiontechnologies. Soligenix's newly patented ThermoVax heat stabilizationtechnology will be used to avoid problems associated with cold-chain vaccinestorage and distribution.
Melioidosis is an often-lethal disease that is endemic inSoutheast Asia and Northern Australia. It is also considered a high-prioritybiodefense threat as defined in the 2012 Public Health Emergency MedicalCountermeasures Enterprise Strategy established by the U.S. Department ofHealth and Human Services with the potential for widespread disseminationthrough aerosol. The disease is caused by Burkholderia pseudomallei, a Gram-negative bacteria that is highly resistantto antibiotic treatment regimens. In many parts of Southeast Asia, mortalityrates are as high as 40 percent, making Melioidosis the third most common causeof death from infectious disease in that region after HIV/AIDS and tuberculosis.
Under the agreement, Intrexon will provide discovery anddevelopment of therapeutic antibody candidates, as well as optimize and expandproduction of human monoclonal antibodies targeting Melioidosis. Soligenix willundertake preclinical and clinical development, regulatory and governmentinteractions, as well as the commercialization of therapeutic products. Inaddition, Soligenix will issue to Intrexon 1,034,483 shares of its commonstock, representing 8.5 percent of Soligenix's issued and outstanding shares.Intrexon will also be granted the right to participate in securities offeringsthat may be conducted by Soligenix in the future as well as the right to makepurchases 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 therapythat will treat both a deadly disease currently affecting millions of people aswell as fight a potential biological weapon.
"Our collaboration with Intrexon is consistent with ourcorporate strategy of building shareholder value through continuous evaluationof new product opportunities and acting upon those that meet Soligenix'smission of delivering disease-modifying therapies in areas of high unmet medicalneed," Schaber says.
Through its BioDefense Division, Soligenix is developingcountermeasures pursuant to the Biomedical Advanced Research and DevelopmentAuthority Strategic Plan of 2011-2016 for inclusion in the U.S. government'sStrategic National Stockpile. Soligenix's lead biodefense products indevelopment are a recombinant subunit vaccine called RiVax, which is designedto protect against the lethal effects of exposure to ricin toxin, andVeloThrax, a vaccine against anthrax exposure. Both vaccines are currently thesubject of a $9.4-million National Institute of Allergy and Infectious Diseasesgrant supporting development of Soligenix's new ThermoVax vaccine heatstabilization technology, for which the company was granted a patent last month.ThermoVax was developed specifically to overcome the problems that areencountered with freeze-drying vaccines that contain aluminum adjuvants whilesimultaneously engineering them to withstand extremes of temperature.
"The granting of the thermostabilization patent is asignificant milestone for the ThermoVax program and is a critical component inour commercialization strategy for vaccines that can avoid the increased costsand logistical burdens associated with cold-chain storage and distribution," statesSchaber. "We expect that the introduction of an effective technology forlong-term stabilization of vaccines has the potential to be a major advance inthe national effort to develop effective countermeasures and therapies forsignificant biothreats and emerging pathogens."
Soligenix has initiated discussions with a number of vaccinecompanies and non-profit organizations regarding the potential forcollaboration on heat-stable versions of their vaccine candidates, Schaberadds.

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