Within our Public Health Solutions segment, Soligenix is primarily focusing on our ricin toxin vaccine program, with other programs pending identification of additional non-dilutive funding sources (e.g., government grants and contracts).
RiVax® is a subunit protein vaccine candidate which is thermostabilized with our proprietary ThermoVax® technology, yielding an easily stored and transported vaccine which does not require refrigeration or freezing, has a long shelf life and has shown an excellent safety profile in clinical trials. RiVax® has the potential to be awarded an FDA Priority Review Voucher upon approval and is targeted for use in military personnel and civilian emergency responders. RiVax® has been granted Orphan Drug designation in the US and Europe. We are currently planning to initiate a Phase 2 clinical study to further test the safety and immunogenicity of RiVax® while also collecting efficacy data in animals to facilitate approval under the FDA Animal Rule.
ThermoVax® is a proprietary heat stabilization platform which allows subunit protein vaccines to be co-lyophilized with alum – yielding an adjuvanted, thermostable powder which can be reconstituted with water for injection immediately prior to use. This unique formulation allows for ambient storage of the vaccines for extended periods of time, foregoing requirements for cold chain storage and shipping. ThermoVax® has been incorporated into the RiVax® product candidate, with additional proof of concept generated with Ebola and HPV vaccines.
OrbeShield® contains the same active ingredient and proprietary formulation as SGX203 and is being specifically considered for the treatment of acute radiation injury to the gastrointestinal tract, an acute inflammatory condition that occurs after exposure to high levels of radiation. OrbeShield® has been awarded Orphan Drug and Fast Track designations in the US for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
SGX943 contains the same active ingredient, dusquetide, as SGX942. The anti-infective action of SGX943, increasing the innate immune response to infection while still controlling inflammation, is of significant importance in many serious infections, where the inflammation is as life-threatening as the infection itself. Because SGX943 interacts with the immune system, and does not directly kill the bacteria, it has been shown to be effective in clinical trials irrespective of the type of bacteria involved or any antibiotic resistance which may have developed. SGX943 has received Fast Track designation in the US for the treatment of melioidosis (a bacterial infection caused by the bacteria Burkholderia pseudomallei).