The US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax, Soligenix’s vaccine for the prevention and post-exposure prophylaxis against Marburg marburgvirus.
Marburg virus is a highly dangerous haemorrhagic fever virus, causing symptoms that include fever, headache, muscle aches, vomiting, and bleeding. It is caused by the Marburg marburgvirus and is highly related to the Ebola virus.
In February and March 2023, outbreaks of the virus were reported in both Equatorial Guinea and Tanzania respectively. The Government of Equatorial Guinea (GREG) reported 16 confirmed cases and 12 deaths, although 23 probable cases, all deceased, were also reported. In Tanzania, one probable case and eight confirmed cases were reported, resulting in one death. The World Health Organization (WHO) declared the outbreaks over in Tanzania in May and in Equatorial Guinea in June 2023.
MarVax is a subunit protein vaccine of recombinantly expressed Marburg marburgvirus glycoprotein, which has demonstrated 100% protection of non-human primates exposed to a lethal injection of the virus in a previous study. The vaccine includes a protein found on the surface of Marbug marburgvirus, as well as an adjuvant which stimulates both humoral and cell-mediated immune responses.
Soligenix developed the vaccine in partnership with the University of Hawaii at Manoa (UHM). The two inked a deal back in 2015 to develop a heat stable subunit Ebola vaccine. Stability studies have demonstrated that MarVax is heat stable for at least two years at temperatures of at least 40 degrees Celsius.
In the announcement accompanying the orphan drug designation, CEO of Soligenix Christopher Schaber 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.”
In January 2023, the Biomedical Advanced Research and Development Authority (BARDA) awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Sudan Ebola virus and Marburg virus diseases. The initial investment was $35m, expanding to up to $214m for advancing the vaccine candidates’ development and production for Sudan Ebola and Marburg viruses.
