Wednesday, December 21, 2016
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today 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.
The RiVax™ project has been funded with Federal funds of up to $24.7 million over the next 6 years, if all contract options are exercised. The collaboration between Soligenix and IDT is specifically funded by Contract No. HHSN272201400039C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“We are pleased to be working with Soligenix on the manufacture of thermostable RiVax™, supported by this contract from NIAID. We believe that IDT provides an excellent combination of manufacturing and vaccine expertise/capabilities to add to the Soligenix team to advance this critical program forward,” stated Ralf Pfirmann, PhD, Chief Executive Officer, of IDT Biologika.
“This collaboration with IDT advances our effort to develop an effective, first-in-class vaccine against ricin toxin exposure in combination with our thermostabilization technology,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “Collaborating with NIAID and IDT is an important step in advancing the development of our ThermoVax® technology platform. Soligenix intends to use this innovative technology to develop a heat stable ricin toxin vaccine capable of achieving the goals of the US Government’s Strategic National Stockpile program.”
