15 August 2017 - - Princeton, New Jersey-based late-stage biopharmaceutical company Soligenix, Inc. (NASDAQ: SNGX) has reported that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has exercised an option to fund good manufacturing practices (GMP) 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 company said.
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 will provide Soligenix with approximately USD 2.5m in additional non-dilutive funding, bringing the total amount awarded to date under this contract to USD 21.2m.
If all contract options are exercised, the total award of up to USD 24.7m will support the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax with the US Food and Drug Administration.
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. 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.
RiVax, Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, contains a genetically altered version of a Ricin Toxin A chain containing two mutations that inactivate the toxicity of the ricin molecule.
Heat stabilization of RiVax is achieved with the company's proprietary ThermoVax technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines.
The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.
By employing ThermoVax during the final formulation of RiVax, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
Similar stabilization at temperatures as high as 50 degrees Celsius for up to 3 months (maximum timepoint tested) have also been demonstrated with other antigens (e.g., human papillomavirus, Ebola and anthrax).
Soligenix' vaccines/biodefense business segment includes active development programs for RiVax, its ricin toxin vaccine candidate; OrbeShield, a GI acute radiation syndrome therapeutic candidate; and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease.