Soligenix is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against bioterrorism agents. Soligenix is developing oral beclomethasone dipropionate, a potent, topically acting corticosteroid, for the treatment and prevention of acute GVHD, prevention of acute radiation enteritis, and the treatment of pediatric Crohn’s disease.

Soligenix’s biodefense products in development are a ricin toxin vaccine called RiVax™, an anthrax vaccine called SGX204, and SGX202 for the treatment of GI ARS. Both RiVax™ and SGX204 are currently the subject of a $9.4 million NIAID grant supporting development of Soligenix’s proprietary vaccine thermostabilization technology, SGX205.

BioDefense and Emerging Diseases

Since 2001, a new sense of vulnerability to radiation, infectious diseases, toxins and chemical agents has generated significant research and development efforts to identify and produce innovative therapies and means to protect against threats that could be used as biological weapons. There is a growing need for products that protect the population against such agents of bioterrorism, as well as against emerging infectious diseases that could arise through natural epidemics. With very few exceptions, such products do not exist, and those that are available for current deployment are based on outdated and sometimes ineffective technologies. Many of these products will only be used in the event of an emergency.

Products to combat biological warfare or bioterrorism will be supplied to the population from medicines stored in the US Strategic National Stockpile (SNS). The federal government has previously established a special fund to acquire biological warfare countermeasures (termed Project Bioshield), which allocated $5.6 billion over a 10-year period to acquire products for the SNS. Realizing that many of these countermeasures do not yet exist, the US government has recently established the Biomedical Advanced Research and Development Authority (BARDA). The existence of BARDA creates a situation in which products arising from research, primarily sponsored by the National Institutes of Health (NIH) and the Department of Defense (DoD), can be prioritized and then developed for large-scale manufacturing and clinical evaluation, and ultimately acquisition of the product for the SNS.

Soligenix, Inc. is addressing the development of products and technologies that can be used to protect against several biological threats considered agents of bioterrorism, consistent with biological warfare threats and emerging diseases that the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH, has identified as high priorities. Soligenix is developing several potential products to prevent morbidity and mortality due to the threat of biological toxins for which preventive vaccination is the most feasible means to protect a susceptible population. This approach is being taken because the known mechanism of protection against toxin exposure is mediated through antibodies in the serum or present on mucosal surfaces that can be elicited by vaccination with subunit immunogens.

Soligenix's process for product development of biodefense products is highly cooperative with government funding, since the government itself will be the final supplier of the products. Currently, Soligenix is operating under a $9.4 million grant award from NIAID, which will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines, including RiVax™ (ricin toxin vaccine), and VeloThrax™ (anthrax vaccine) that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals. In addition, Soligenix is expanding the range of applicability of its lead product, oral beclomethasone dipropionate (BDP), referred to as OrbeShield™, for gastrointestinal Acute Radiation Syndrome (ARS).

BioTherapeutics

Beclomethasone 17,21-dipropionate (BDP) is a highly potent, topically active corticosteroid with a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of allergic rhinitis and asthma in both adults and children. The rationale for its administration is that it provides a potent topical anti-inflammatory effect with less systemic toxicity than a comparably effective systemic corticosteroid. 

Soligenix has several proprietary products designed to take advantage of the topical activity of BDP for the treatment of gastrointestinal inflammation: orBec®, SGX201, and SGX203.

Christopher J. Schaber, PhD

President and Chief Executive Officer

Christopher J. Schaber, PhD has over 23 years experience in the pharmaceutical and biotechnology industry. Dr. Schaber has been Soligenix's President and Chief Executive Officer and a director since August 2006. He also serves on the board of directors for the Alliance for BioSecurity and BioNJ, and is a member of the corporate councils for both the National Organization for Rare Diseases (NORD) and the American Society for Blood and Marrow Transplantation (ASBMT). Prior to joining the company, Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, preclinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. During his tenure at Discovery Laboratories, Inc., Dr. Schaber played a significant role in raising over $150 million through both public offerings and private placements. From 1996 to 1998, he was a co-founder of Acute Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996, he was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989 to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc., and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA from Western Maryland College, his MS in Pharmaceutics from Temple University School of Pharmacy and his PhD in Pharmaceutical Sciences from the Union Graduate School.

Robert N. Brey, PhD
Senior Vice President and Chief Scientific Officer

Robert N. Brey has more than 29 years experience in the pharmaceutical and biotechnology industry. He has held various positions within Soligenix since 1996, including Vice President, Vaccine Development and Vice President of Research and Development. Prior to joining the company, he held scientific and management positions in the Lederle-Praxis division of American Cyanamid, now a division of Wyeth. While at Lederle-Praxis, Dr. Brey was manager of Molecular Biology research for vaccines and project manager for development of oral vaccines from 1985 through 1993, including projects for non-typable Haemophilus, Salmonella, B. pertussis and malaria. Before entering into drug and vaccine delivery, he held senior scientific positions at Genex Corporation from 1982 through 1985, one of the first biotechnology companies formed to exploit genetic engineering. Dr. Brey received his BS in biology from Trinity College, his PhD in microbiology from the University of Virginia and performed postdoctoral studies at MIT with Nobel laureate Salvador Luria.

Kevin Horgan, MD
Senior Vice President and Chief Medical Officer

Kevin Horgan, MD is a board-certified gastroenterologist with more than 25 years academic and pharmaceutical experience. He has conducted research in cellular immunology and has experience in the care of patients with inflammatory bowel disease, including graft-versus-host disease (GVHD). Prior to joining Soligenix, Dr. Horgan served from 1997 to 2005 as Senior Director of Clinical Research at Merck & Co., Inc., where he led the development of the first neurokinin-1 receptor antagonist, EMEND®, which was approved for the prevention of chemotherapy-induced nausea and vomiting. From 2006 to 2008, he was Vice President of Clinical Immunology at Centocor Ortho Biotech Inc., where he designed and conducted gastroenterology clinical studies for new compounds and indications including REMICADE™. From 2008 until joining Soligenix, Dr. Horgan was Head of Internal Medicine Research and Development in medical imaging with specific focus on oncology and neuroscience with GE Healthcare (a unit of General Electric Company). Dr. Horgan received his medical degree from University College, Cork, Ireland and completed training in internal medicine with Queen Elizabeth Hospital, Birmingham, United Kingdom and Johns Hopkins Hospital, Baltimore, MD, followed by an immunology research fellowship with the National Cancer Institute in Bethesda, MD. His research on human T-cell differentiation, activation and migration with emphasis on integrin adhesion molecules provided a framework for subsequent validation of three therapeutic targets. Dr. Horgan then did a fellowship in gastroenterology with University of California at Los Angeles and was then an Assistant Professor of Medicine there, where his research focus was gastrointestinal inflammatory disorders.

Joseph Warusz, CPA, MBA
Vice President of Finance and Acting Chief Financial Officer

Joe Warusz has more than 28 years of financial management experience in public and private life science companies as well as large pharma. From 1979 to 1983, he was employed at Peat Marwick Main & Company (now KPMG LLP) working with the firm’s clients in various industry segments. From 1983 through 1998, he served in various Finance, Auditing and Controller roles with Bristol-Myers Squibb. From 1998 through 2011, he held senior financial positions with Amicus Therapeutics, Inc., Orchid Cellmark, Inc. and NexMed, Inc., as well as consulting assignments at Ardea BioSciences, Inc. and NovaDel Pharma, Inc., all R&D-focused companies in the biotechnology and specialty pharmaceutical arenas. He received his Bachelor degree in Business and Accounting from Drexel University in 1981 and received his MBA in Finance from Drexel University in 1991 and is a Certified Public Accountant licensed in the State of Pennsylvania.