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With very few exceptions, such products do not exist, and those that are available for current deployment are based on outdated and sometimes ineffective technologies.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, infectious agents or radiation insult. In the area of biological toxins, Soligenix is focusing on preventive vaccination as the most feasible means to protect a susceptible population because toxin exposure is mediated through antibodies in the serum or present on mucosal surfaces that can be elicited by vaccination with subunit immunogens. Soligenix is also developing therapeutic agents for infectious agents which are known to be incompatible with vaccination approaches and for treatment of the sequelae to radiation exposure.
Soligenix’s process for product development of biodefense products is highly cooperative with government funding, since the government itself will be the final customer for the products.
Currently, Soligenix has government funded programs in all 3 areas:
- Vaccine for Plant-Based Toxin: Soligenix is currently operating under an up to $24.7 million contract award from NIAID, which is funding nonclinical and clinical development of RiVax® (ricin toxin vaccine), that is stable at elevated temperatures and does not require cold chain storage or distribution channels.
- Therapeutic for Infectious Disease: Soligenix is expanding the applicability of its SGX94 technology platform, assessing its applicability for the treatment of melioidosis, a top 5 tier Biothreat. This program is currently funded under a $300,000 Small Business Innovation Research (SBIR) grant from NIAID.
- Therapeutic for Radiation Injury: 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) under contracts awarded by BARDA and NIAID totaling up to $26.3 million and $6.4 million, respectively.