Sudan Ebola Virus Vaccine Candidate Gets Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SuVax^™ for prevention and postexposure prophylaxis against Sudan ebolavirus (SUDV) infection.

SuVax is a subunit protein vaccine of recombinantly expressed Sudan ebolavirus glycoprotein. The designation was supported by nonhuman primate efficacy data, which showed the investigational vaccine provided 100% protection against SUDV infection. All the animals that received SuVax remained healthy and survived. The vaccine candidate has also been shown to be stable for at least 2 years when stored at temperatures of 40 degrees Celsius (104 degrees Fahrenheit).

“SuVax is based on our novel vaccine platform which includes 3 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,” explained Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix.

There are 4 ebolaviruses that are known to cause disease in humans. In 2019, the FDA approved the first Ebola virus vaccine, Ervebo; however, the vaccine only prevents disease caused by Zaire ebolavirus. “With recent outbreaks in 2022 and 2023, developing vaccines for all Ebola type diseases remains an important worldwide priority,” said Dr Donini.

The FDA’s Orphan Drug designation is granted to therapies intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals in the US.