The National Institute of Allergy and Infectious Diseases (NIAID) recently exercised an option with Soligenix, Inc. to fund its good manufacturing practices-compliant ricin vaccine, called RiVax, bulk drug substance and finished drug product manufacturing in order to conduct future preclinical safety and efficacy studies.
RiVax is the company’s proprietary heat-stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. It contains a genetically-altered version of the toxin chain, called ricin toxin A, which contains two mutations that inactivate the toxicity of the ricin molecule.
“The exercise of this option demonstrates the positive and productive collaboration between NIAID and the Soligenix team,” Christopher Schaber, president and CEO of Soligenix, said.
The exercised option from NIAID will provide approximately $2.5 million in additional non-dilutive funding, which brings the total award under the RiVax contact to $21.2 million.
Should all contract options be exercised by NIAID, the Princeton, New Jersey-based Soligenix will receive a total award of $24.7 million to support all preclinical, manufacturing, and clinical development activities needed to advance the vaccine to the U.S. Food and Drug Administration (FDA).
“With this recent option exercise by NIAID, along with the one exercised this past June, we now have approximately $4.5M in additional non-dilutive funding that will allow us to proceed with both GMP manufacture and preclinical efficacy studies,” Schaber said. “We look forward to accelerating this important work with NIAID and engaging the FDA to advance the RiVax program. We thank the NIAID team for their continued support and contribution to the Soligenix development program.”
Ricin in a toxic, naturally-occurring protein produced from the seeds of the castor oil plant. According to the European Food Safety Authority, the estimated lethal oral dose for humans is approximately one milligram per kilogram of body weight. It has been used as a chemical warfare agent in the past, most notably appearing during World War I.