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 its ongoing collaboration with the University of Hawaiʻi at Mānoa (UH Mānoa) is being expanded to assess potential coronavirus vaccines (including COVID-19).
Under the Company’s Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Mānoa have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). Soligenix and its collaborators are expanding the technology platform to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19.
The vaccine platform includes three essential components:
1) a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification;
2) an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and
3) a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.
The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. These same components can now be applied to coronavirus vaccine, using well-defined surface glycoprotein(s) from one or more coronaviruses, which will include key antigens expected to be protective for COVID-19. The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19.
“Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the potential for a broadly applicable and easily distributed vaccine. We are delighted with our successes on development of filovirus and flavivirus vaccines using our platform and look forward to accelerated studies with the coronaviruses,” stated Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM.
“It is rewarding to see ongoing work by JABSOM investigators and collaborators expanding on successful research on filovirus vaccines (protecting against viruses such as Ebola and Marburg virus) that may help us make unique life-saving contributions during this difficult time in healthcare. The prospect of a science lab in Hawaiʻi helping develop a vaccine amid the COVID-19 pandemic is a testament to the importance of local research in Hawaiʻi,” stated JABSOM Dean Jerris R. Hedges, MD, MS, MMM.
“We believe that creating a vaccine with enhanced stability at elevated temperatures that can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other vaccines currently in development and simplifies worldwide distribution,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “With the rapid advancement of the filovirus vaccine platform, we feel the program is optimally poised to look at other viruses and infections, including COVID-19.”