The company made the announcement on Mar. 17, noting that NIAID provided the funding by exercising an option on an existing contract (HHSN272201400039C), which provides Soligenix with an additional $660,000 in funding to support required US Food and Drug Administration (FDA) regulatory activities.
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 FDA.
“The exercise of this option award reflects NIAID’s ongoing commitment to advance development of 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.
There are currently no effective treatments for ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
The development of RiVax has been sponsored through a series of grants from both NIAID and the 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.
ThermoVax® and RiVax™ are protected terms by Soligenix.