Soligenix, Inc. today announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised its option to advance the development of Soligenix’s heat stabilized ricin toxin vaccine, RiVax.
The overall objectives of the contract are to advance the development of Soligenix’s thermostabilization technology, ThermoVax, combined with the company’s ricin toxin vaccine, RiVax, as a medical countermeasure to prevent the effects of ricin exposure.
The exercised option for the contract will provide Soligenix with an additional $2.7 million in funding. If all contract options are exercised, the total award of up to $24.7 million will support the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax with the US Food and Drug Administration (FDA).
“The execution of the first option reflects NIAID’s ongoing commitment to develop viable thermostabilization technologies that can be applied to vaccines that provide for enhanced stability and the ability to avoid the burdensome logistics of cold chain distribution,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “It also highlights the government’s commitment to identification and development of countermeasures to protect both the public and, more likely, first responders, in the event of ricin exposure.”
Ricin toxin is a plant toxin and potential biological weapon because of its stability, high potency, and availability as a by-product of castor oil production. Ricin comes in many forms like powder, mist, or pellet. Ricin can also be dissolved in water and other liquids. The US Centers for Disease Control and Prevention (CDC) estimate the lethal dose in humans is about the size of a grain of salt. Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. Ricin is especially toxic when inhaled.
RiVax is Soligenix’s proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin. RiVax contains a genetically altered version of a RTA chain containing two mutations that inactivate the toxicity of the ricin molecule.
The development of RiVax has been sponsored through a series of grants from both NIAID and the U.S. Food and Drug Administration (FDA), which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine originated. To date, Soligenix and Dr. Ellen Vitetta and colleagues 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.
Source: Soligenix press release, adapted. RiVax and ThermoVax are registered, protected terms by Soligenix.