Soligenix Granted FDA Orphan Drug Designation for SuVax Active Ingredient

The United States Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in Soligenix Inc.’s SuVax, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for “the prevention and post-exposure prophylaxis against SUDV infection.”
 
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S.  In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.
 
“SuVax is based on our novel vaccine platform which includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity, and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial,” stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. “The SuVax vaccine specifically addresses the potentially lethal Sudan Virus Disease, caused by SUDV.”
 
According to Donini, SUDV is a type of ebolavirus for which there is no current treatment or vaccine. The SuVax vaccine has demonstrated 100% protection of non-human primates infected with a lethal amount of SUDV.
 
Although vaccines exist for Zaire ebolavirus, they are ineffective against SUDV. With recent outbreaks in 2022 and 2023, developing vaccines for all Ebola type diseases remains an important worldwide priority.
 
Donini adds: “The FDA’s decision to grant orphan drug designation signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing patent estate surrounding this novel technology.”