Benzinga | Aug 18, 2021 08:53AM EDT

Soligenix Announces Preclinical Data With Multiple Heat Stable Filovirus Vaccine Candidates

Soligenix, Inc. (NASDAQ:SNGX) (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 today positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at the at the University of Hawaii at Mnoa (UHM) describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. These vaccine candidates contain highly purified protein antigens combined with the novel CoVaccine HT(tm) adjuvant, in both monovalent (single antigen) and bivalent (two antigen) formulations. Most recently, efforts to formulate all three antigens and adjuvant into a thermostable single-vial vaccine platform has also been shown to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge, with further development to test efficacy against other filovirus infections ongoing.

"Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable vaccine particularly valuable," stated Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM, "Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the applicability of thermostabilization of multiple antigens with the potential for a broadly applicable and easily distributed vaccine. Once developed, such a vaccine may be able to address emerging outbreaks, such as the Marburg virus infection that appeared in Guinea recently. We feel that this technology may be an important contribution to Dr. Fauci's proposed idea to develop prototype vaccines against the top 20 viral families that may also cause pandemics. Having such a platform available would likely enable broader and faster worldwide vaccination campaigns addressing future health emergencies. In addition, the ability to combine antigens in the formulation also enables generation of potentially broader protective vaccines."

"The continued advances in the filovirus program demonstrates the program's maturity and overall ability to successfully develop vaccines against these lethal viral threats," 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. This most recent demonstration of protective efficacy against subsequent challenge continues to advance the overall platform, as well as the Sudan ebolavirus program specifically. Using this platform, we also continue to accelerate our joint COVID-19 vaccine effort, called CiVax(tm), with Dr. Lehrer and look forward to discussing further developments for both programs in the near future."

Under the Company's Public Health Solutions business segment, ongoing collaborations with Dr. Lehrer, 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 filoviruses. The thermostabilized filovirus vaccine program is continuing to advance with the support of a National Institute of Health (NIH) grant R01-AI132323 (awarded to the University of Hawaii) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix). Work to date has demonstrated the compatibility of lyophilizing both antigen and adjuvant in the same vial, with reconstitution with sterile water for injection immediately prior to use. This simple delivery format, as well as the compatibility with ambient storage, enables vaccines that significantly reduce the logistical hurdles that have been required for addressing the current pandemic or deployment of other Ebola virus vaccines in recent outbreaks in Central and West Africa.