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Sunday, January 29th, 2023

BARDA invites Soligenix to submit contract proposal for thermostabilized Sudan Ebola, Marburg virus vaccines

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Biopharmaceutical company Soligenix, Inc. recently received an invitation from the Biomedical Advanced Research and Development Authority (BARDA) to submit a contract proposal for millions of dollars in development support for single vial, thermostabilized subunit vaccines for the Sudan ebolavirus and Marburg marburgvirus.

Known as SuVax and MarVax, respectively, these vaccines would be adjuvanted and heat stable, in addition to targeting infectious diseases where no protective vaccines currently exist. Soligenix earned the offer following the publication of a white paper on SuVax, which proposed the development of the vaccine through Phase 1 clinical studies utilizing $25 million over five years. BARDA tacked on the request for MarVax, a medical countermeasure for another filovirus.

“We are excited about the favorable review of our white paper by BARDA and by their invitation to submit a full contract proposal,” Dr. Christopher Schaber, president & CEO of Soligenix, said. “Although a contract award is not guaranteed, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting our heat stable filovirus vaccine platform, including vaccine candidates directed towards Sudan ebolavirus and Marburg marburgvirus. This is particularly relevant given the outbreak of Sudan viral disease in Uganda for which there is no current protective vaccine available.”

SuVax previously provided full protection four weeks after vaccination in a three-dose series given to non-human primates. Similar efficacy was observed with MarVax, and the development of both has been part of an ongoing partnership between Soligenix and the University of Hawaiʽi at Mānoa.

Containment activities are currently underway for a Sudan ebolavirus outbreak in Uganda. Ebola Virus Disease, in general, is caused by one of six species of the Ebolavirus. While the best known of these is Zaire ebolavirus – what the world traditionally knows as the Ebola Virus – Sudan virus is the second-most common cause of human infection. These filoviruses, as they are known, likely come from certain animal species in Africa, though the exact reservoir host for many remains unknown. Long feared for their pandemic potential, filoviruses require direct contact with bodily fluids or infected animals to transmit. Nonetheless, the mortality rates for these infections are extremely high. While cold storage restrictive vaccines are available for Ebola virus, none have yet been produced for Marburg virus or Sudan virus.

If Soligenix submits a proposal for development, it will be technically and scientifically reviewed by BARDA before being considered for a contract award.