On Mar. 4, 2021, Soligenix announced publication of pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. The article was posted as an accelerated preprint on bioRxiv. The work continued under a $1.5 million Small Business Innovation Research (SBIR) grant awarded to Soligenix in December 2020.

CiVax™ is the Company’s heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. Ongoing collaborations with Axel Lehrer, PhD, Associate Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa, have confirmed the feasibility of developing a broadly immunogenic vaccine for COVID-19.

Using an efficient expression system in Drosophila S2 cells developed by Hawaii Biotech Inc., full-length Spike protein antigens have been produced and tested for immunogenicity in this latest work. These latest results demonstrate the immunogenic potential of the full-length CiVax™ antigen in combination with CoVaccine HT™, specifically in the context of SARS-CoV-2.

While a number of vaccines are available worldwide under Emergency Use Authorization, the requirement for cold chain shipping and timely administration, coupled with manufacturing scale up logistics, have limited the world’s supply. Rapid vaccine administration worldwide is necessary to curtail disease spread and slow or pre-empt evolution of mutations, which may abrogate the effectiveness of current vaccine approaches.

Previous work with the novel CoVaccine HT™ adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine HT™ can be thermostabilized both alone and in combination with antigens, potentially yielding a single vial presentation of the vaccine, which would not require cold chain distribution or storage.