Soligenix Expands Pipeline with Acquisition of Novel Innate Defense Regulator Clinical Program Newly Acquired SGX94 Technology Strengthens Both BioTherapeutics and Vaccines/BioDefense Business Segments

PRINCETON, N.J., Dec. 18, 2012 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today the acquisition of a novel drug technology, known as SGX94, representing a unique approach to modulation of the innate immune system.  SGX94 is an innate defense regulator (IDR) that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1.  As part of the acquisition, Soligenix acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94, which is poised to enter Phase 2 clinical testing in humans and is highly synergistic with the company's existing development pipeline.

Due to its novel mechanism acting on the regulatory molecule p62, SGX94 is simultaneously anti-inflammatory and anti-infective.  SGX94 is active in a wide range of disease models including life-threatening bacterial infections as well as the severe side-effects of chemo- and/or radiation-therapy.  Moreover, since SGX94 targets the host and not the bacteria, it evades antibiotic resistance mechanisms and has potential as both an alternative and/or an adjunct to antibiotic therapy.  SGX94 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and is the subject of an open Investigational New Drug (IND) application which has been cleared by the US Food and Drug Administration.  SGX94 is being developed pursuant to discoveries made by Professors B. Brett Finlay and Robert Hancock of the University of British Columbia, Canada with approximately $40 million having been put towards its development to date, inclusive of government grants.

In addition to SGX94, the acquired technology package includes other analogs and crystal structures of SGX94 with its protein target p62, opening the possibility for a pipeline of additional products to be developed.  Soligenix intends to continue development of SGX94 in both of its key business segments, namely, cancer supportive care applications, such as oral mucositis under its BioTherapeutics business segment, and infectious disease applications such as melioidosis under its Vaccines/BioDefense business segment.

Dr. Finlay commented, "I look forward to working with Soligenix to continue to develop SGX94, which has the potential to be a ground-breaking technology for the treatment of infectious diseases and related innate immune disorders. I am confident that Soligenix has the drug development expertise to successfully develop SGX94 so that new treatments can be made available to these patients." 

"We are very excited by the acquisition of this cutting edge science which represents a new paradigm for the treatment of tissue injury and infection," stated Christopher J Schaber, PhD, President & Chief Executive Officer of Soligenix. "With SGX94 we will be able to leverage our experience in clinical development of cancer supportive care and biodefense products.  We also anticipate the potential for a number of grant funding opportunities for SGX94 across both segments of our business."

About Innate Immunity

The immune system is constantly exposed to pathogenic microorganisms (bacteria, virus, fungi, and parasites) but has evolved a powerful response to deal with these threats to our health. This response has been divided into two general types of reactions: reactions of innate immunity and reactions of adaptive immunity. Innate immunity is the "first responder" component of the immune system that is immediately activated to destroy invading microorganisms and trigger inflammation that contributes to blocking their assault.  If microorganisms breach the innate immune system, adaptive immunity is activated. Adaptive immunity uses T and B cells to produce antibodies and killer cells to destroy infected cells. The two components of the immune system provide excellent protection against infections but they also pose a risk. If the activation threshold of either component is too low, or if activation is excessive, inflammatory disease may follow.

The innate immune system is a highly integrated system of cells involving both circulating blood cells and cells in tissues protecting us from pathogens at all body surfaces that interface with the external environment: skin, mouth, gastro-intestinal tract and lung. Innate immunity is dependent on rapidly sensing infection or damage and responding quickly with both inflammation and host repair or anti-infective functions. When excessive activation of innate immunity causes inflammation, modulation of the activated innate immune system can re-direct the system to decrease inflammatory responses and increase the anti-infection or healing responses.  The innate immune system responds quickly by sensing non-specific molecules released by the process of infection and damage through its Toll-like receptors and associated receptors. The p62 molecule integrates and regulates the signals sensed by these receptors and can re-direct the response of the innate immune system in a benign way without perturbing the function of the adaptive immune system. 

About Soligenix, Inc.

Soligenix is a development 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. 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), acute radiation enteritis (SGX201) and chronic Graft-versus-Host disease (orBec®).  

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 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. 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 $600,000 NIAID Small Business Innovation Research (SBIR) grant. OrbeShield™ has previously demonstrated statistically significant preclinical survival results in two separate canine GI ARS studies funded by the NIH.

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. Statements that are not historical facts, such as "anticipates," "believes," "intends," 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 or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, 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 grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, 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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