Announcement • May 26
Soligenix Announces Suitability of Vaccine Platform for Bundibugyo Virus
Soligenix, Inc. noted that the recent Congo outbreak of Bundibugyo virus, an Orthoebolavirus, will require new vaccine formulation efforts. Soligenix, in collaboration with Axel Lehrer, PhD, Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawai?i at Manoa, has previously developed bivalent and trivalent vaccines, constructed from antigens against Ebola virus, Sudan virus and Marburg virus and the CoVaccine HT adjuvant, demonstrating thermostability, immunogenicity and durable efficacy. Previous work in Dr. Lehrer's laboratory has demonstrated platform compatibility of the key Bundibugyo virus antigen enabling rapid development of a protein-based thermostable subunit vaccine. Thermostable vaccine formulations in collaboration with Soligenix demonstrated extended stability that is particularly relevant for the use of these vaccines in virus-endemic countries in Africa, as well as in the context of strategic national stockpiles and preparations for potential larger outbreaks and pandemics. A single-vial subunit vaccine that can be shipped at ambient temperatures and then needs to only be reconstituted with sterile water immediately prior to use has the potential to improve vaccination efforts globally by simplifying storage and distribution logistics not only as a stand-alone vaccine, but also as a practical add-on booster in persons previously vaccinated with other vaccines. The ThermoVax platform has successfully thermostabilized vaccines for ricin toxin, for filoviruses such as Ebola, Sudan and Marburg, and for COVID, and as such is a well-established thermostabilization strategy that enhances the long-standing protein subunit vaccination technology. The ability of these vaccines to induce rapid broad immune coverage, even when administered after other primary vaccination series, is another marked advantage. The use of subunit vaccines that has been built on years of proven vaccine technology may also provide a very safe option for people of all ages. These proprietary filovirus vaccines are subunit protein vaccines of recombinantly expressed Orthoebolavirussudanense glycoprotein, Orthoebolavirus zairense glycoprotein and Orthomarburgvirusmarburgense glycoprotein developed in partnership with Dr. Axel Lehrer at the University of Hawai?i at Manoa. Dr. Lehrer's team has also previously used the same expression platform to produce glycoprotein of Orthoebolavirus bundibugyoense, which has already found application in collaborative seroepidemiology studies conducted in the Democratic Republic of the Congo. All filovirus vaccines include a protein found on the surface of each virus, to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with Generally Regarded As Safe (GRAS) excipients that enable lyophilization (i.e., freeze-drying) of the vaccines. The resulting products are manufactured as a heat stable powder in a vial which is reconstituted with widely available water for injection immediately prior to use. Alone or in combination, these heat stable protein subunit vaccines, have protected up to100% of non-human primates exposed to a lethal injection of the corresponding virus. Stability studies have demonstrated that these vaccines are heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit). Manufacture of the recombinant proteins utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies. Soligenix has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for the prevention and post-exposure prophylaxis against Sudan orthoebolavirus and Marburg orthomarburgvirus infection. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designations also position 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. There are approved vaccines for Ebola virus, requiring stringent ultra-low cold-chain storage, but no efficacious and approved vaccines are available for Sudan, Bundibugyo, or Marburg virus.
