News Feature | September 23, 2014

Soligenix Wins $24.7M NIAID Contract For Development Of Ricin Toxin Vaccine

By C. Rajan, contributing writer

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Soligenix, a New Jersey-based biotech company, has just been awarded a $24.7 million contract by the National Institute of Allergy and Infectious Diseases (NIAID), which will advance the development of Soligenix’s thermostabilization technology, ThermoVax, and its ricin toxin vaccine, RiVax, as a medical countermeasure (MCM) to prevent the effects of ricin exposure.
 
The federal contract will provide financial support of approximately $5.8 million for a 16 month base period, as well as several contract options that would extend the contract award for up to six years. If Soligenix exercises all the contract options, then it will be supported through the preclinical, manufacturing, and clinical development activities necessary to advance RiVax with the U.S. FDA.

“Securing this highly competitive NIAID contract provides further recognition as to the innovative quality and potential impact of both our vaccine and thermostabilization technologies,” Christopher J. Schaber, PhD, President, and CEO of Soligenix said. “With this new contract award, the Company now has up to $57 million in NIAID and BARDA funding to advance the biodefense business segment.  We thank NIAID for their past and present support and look forward to collaborating closely with them as we advance RiVax development towards potential FDA licensure and procurement for the national stockpile.”

Ricin toxin is an extremely powerful plant toxin which can be a bioterror threat. Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins. Ricin is especially toxic when inhaled and results in local tissue necrosis and general organ failure leading to death within several days of exposure. There are currently no effective means to prevent the effects of ricin poisoning.

Soligenix is preparing RiVax as a heat stable vaccine using its ThermoVax technology, thus increasing its shelf life and ease of storage. The RiVax vaccine contains a genetically altered version of RTA chain containing two mutations that inactivate the toxicity of the ricin molecule. Phase 1A and 1B clinical trials have already demonstrated the effectiveness of the vaccine.

The vaccine was originally developed at the University of Texas Southwestern (UTSW). To date, Soligenix and the researchers at UTSW have collectively received approximately $25 million in grant funding from NIAID for development of RiVax and related vaccine technologies. RiVax would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

Soligenix is developing several novel products in the areas of inflammation, oncology, and biodefense. The company has also developed a vaccine against anthrax exposure, VeloThrax, using the same ThermoVax technology. The company recently announced positive study results for the VeloThrax vaccine. Soligenix also expanded its oncology pipeline this month through the acquisition of a Phase 3 ready orphan drug candidate, SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).