Date: 2016-12-20
Type of information: Collaboration agreement
Compound: production technology for the RiVax™ vaccine
Company: Soligenix (USA - NJ) IDT Biologika (Germany)
Therapeutic area: Rare diseases
Type agreement: collaboration manufacturing bioproduction
Action mechanism: vaccine. RiVax™ is a proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin. The vaccine 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 and contracts from both the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, 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 $50 million in grant and contract 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.
Disease:
Details: * On December 20, 2016, Soligenix announced that it has extended its collaboration with IDT Biologika (hereafter referred to as IDT) for the manufacture of RiVax™, the Company's proprietary heat-stable ricin toxin vaccine. Under the terms of the collaboration, Soligenix will scale-up the formulation/filling processes and continue development and validation of analytical methods established at IDT to advance the program towards a commercially viable scalable technology for the RiVax™ vaccine product compliant with current Good Manufacturing Practices (cGMPs). Soligenix has been developing RiVax™, in conjunction with its heat stabilization technology, ThermoVax®, as a heat-stable biodefense vaccine. RiVax™ has demonstrated both 100% protection in a preclinical model of lethal ricin exposure and stability up to 1 year at 40 degrees Celsius (104 degrees Fahrenheit) facilitating storage and distribution at ambient temperature. RiVax™ is being developed as a safe and effective biodefense vaccine which does not require cold chain shipment and storage.
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