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Soligenix, Inc. (SNGX) Reports Publication Demonstrating Thermostabilization of Filovirus Vaccine Antigens

September 15, 2020 7:33 AM EDT

Soligenix, Inc. (NASDAQ: SNGX) announced today publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization. The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences. A copy of manuscript has been made available here.

Under the Company's Public Health Solutions business segment, ongoing collaborations with Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and Hawaii Biotech Inc. (HBI), as well as work conducted by Theodore Randolph, PhD, Professor, Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering at the University of Colorado, Boulder have demonstrated the feasibility of developing heat stable subunit protein vaccine formulations for filovirus vaccines. Protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus. 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). These most recent results demonstrate the thermostabilization of three virus glycoproteins (from Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus), and the identification of key stability-indicating assays to further support mono-, bi- and tri-valent vaccine formulations.

"Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable vaccine particularly valuable," stated Dr. Lehrer, "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the applicability of thermostabilization and the potential for a broadly applicable and easily distributed vaccine. With Marburg virus continuing to be an unmet medical need of priority to the US government, we are now focusing and accelerating evaluations of the Marburg virus vaccine specifically."

"The continued advances in the filovirus program demonstrates the program's maturity and overall developability," noted Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "The compatibility with thermostabilization, and the identification of key stability indicating assays, are both hallmarks of a potentially broadly applicable vaccine platform. Using this platform, we also continue to accelerate our joint COVID-19 vaccine effort, called CiVax™, with Dr. Lehrer and look forward to further developments for both programs."



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