Proactive Investors - Soligenix (NASDAQ:SNGX) shares surged more than 44% after the biopharmaceutical company won orphan drug designation from the US regulator for the active ingredient in its MarVax vaccine for Marburg virus disease.
The designation specifically relates to the prevention and post-exposure prophylaxis against infection from the Marburg virus (MARV).
There is currently no approved vaccine and treatment for Marburg virus disease, a rare but severe hemorrhagic fever and member of the Filoviridae family that also includes Zaire ebolavirus and Sudan ebolavirus, which cause types of Ebola virus disease.
The company’s MarVax is a subunit protein vaccine of recombinantly expressed in MARV glycoprotein.
“Although MARV has caused fewer outbreaks [than Ebola], they remain highly fatal and a significant risk in continental Africa, with the most recent outbreak occurring in 2023,” Soligenix (NASDAQ:SNGX) CEO Dr Christopher Schaber said.
He highlighted that, unlike the only approved vaccines for Filovirus-type disease which is specific to Zaire ebolavirus, MarVax is a heat-stable subunit vaccine with a novel adjuvant.
“Subunit vaccines are a gold standard technology for safety and are also broadly applicable across the population, especially when combined with an effective adjuvant,” the CEO said.
"Elements of this subunit vaccine platform have been utilized in our ricin toxin, Filovirus and COVID-19 vaccine candidates, indicating its broad applicability. We have also demonstrated the ability to package more than one vaccine antigen in a single vaccine, particularly against MARV and Sudan ebolavirus where there are currently no available vaccines.”
The US Food and Drug Administration's orphan drug designation provides Soligenix with seven years of market exclusivity upon final approval and other financial and regulatory benefits, including access to government grants for clinical trials and certain tax credits.
The news comes after the company last week announced it has also been granted orphan designation from the agency for the active ingredient in SuVax, its vaccine addressing Sudan virus disease.
The designation is for its subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein for the prevention and post-exposure prophylaxis against SUDV infection.
Soligenix shares had added 44.1% at $0.56 in the early afternoon on Monday.