FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for “the prevention and post-exposure prophylaxis against MARV infection.”

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.

“Marburg marburgvirus causes Marburg Virus Disease, a highly related disease to the more commonly known Ebola Virus Disease. Although MARV has caused fewer outbreaks, they remain highly fatal and a significant risk in continental Africa, with the most recent outbreak occurring in 2023. There is no approved vaccine for MARV, and the only approved vaccines for filovirus type disease is specific to Zaire ebolavirus. Unlike the approved vaccines, which depend on using a different inactive or attenuated virus to stimulate the immune system, MarVax™ is a heat stable subunit vaccine with 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,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “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 FDA’s decision to grant orphan drug designation to both the MARV and Sudan ebolavirus vaccine candidates 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 and the filovirus program.”