Therapy Areas: Vaccines
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
12 April 2024 -

Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the company), a late-stage biopharmaceutical company, announced on Thursday that it has received orphan drug designation for the active ingredient in SuVax, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for 'the prevention and post-exposure prophylaxis against SUDV infection.'

The designation is approved by the Office of Orphan Products Development of the United States (US) Food and Drug Administration (FDA).

In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also opens up a wide range of financial and regulatory benefits, which includes government grants for carrying out clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.

The product, a subunit protein vaccine of recombinantly expressed Sudan Ebola virus glycoprotein, is developed in collaboration with Dr Axel Lehrer at the University of Hawaii at Manoa.

Oreola Donini, PhD, senior vice president and chief scientific officer of Soligenix, said, '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. The SuVax vaccine specifically addresses the potentially lethal Sudan Virus Disease, caused by SUDV. 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. 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.'