Soligenix announced the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has exercised an option to fund GMP (good manufacturing practices) compliant RiVax bulk drug substance and finished drug product manufacturing, which is required for the conduct of future preclinical and clinical safety and efficacy studies. The overall objectives of the contract are to advance the development of Soligenix's thermostabilization technology, ThermoVax, in combination with the company's ricin toxin vaccine, RiVax, as a medical countermeasure to prevent the effects of ricin exposure.
The exercised option for contract #HHSN272201400039C will provide Soligenix with approximately $2.5M in additional non-dilutive funding, bringing the total amount awarded to date under this contract to $21.2M. 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 exercise of this option demonstrates the positive and productive collaboration between NIAID and the Soligenix team," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "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. 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 toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact it is readily extracted from by-products of castor oil production. Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids. The US Centers for Disease Control and Prevention estimates that 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. Ricin works by entering cells of the body and preventing the cells from making the proteins it needs. Without the proteins, cells die, which is eventually harmful to the entire body.
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.