SNGX on it's way UP with this PR today 3/4 on CiVax as heat stable for Covid:
"Soligenix Highlights Publication Of Pre-Clinical Studies For The CiVax COVID-19 Vaccine Program
7:05 am ET March 4, 2021 (Benzinga) Print
PRINCETON, N.J., March 4, 2021 /PRNewswire/ -- 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 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 titled, "Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice," has been posted as an accelerated preprint on bioRxiv (available here). This work will continue under a $1.5M 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 Hawai?i at Manoa, 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.
"Our work to date has demonstrated not only the feasibility of rapidly adaptable and cost-effective manufacturing of the required vaccine antigens, but also the potential for a broadly applicable and easily distributed vaccine," stated Dr. Lehrer. "We are delighted with our earlier successes on development of filovirus and flavivirus vaccines with this platform. The results in our latest manuscript confirm that the advantages of our vaccine platform with the CoVaccine HT™ adjuvant can also be realized in the context of SARS-CoV-2, while we continue our work to rapidly advance development of a heat stable subunit COVID-19 vaccine in collaboration with Soligenix. Next steps will include evaluation of immunogenicity in a non-human primate model and assessment of antibody coverage with key variants of concern."
"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 simplify worldwide distribution, leading to a faster resolution of this pandemic and curtailing the further evolution of the virus," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Once fully developed, we anticipate that our platform would be easily updated to address specific variants directly. Our approach appears to be unique in its use of a well-established, well-understood, and safe, subunit platform coupled with a novel adjuvant and a thermostabilizing formulation. We are very encouraged with the latest results and look forward to continuing to advance development of CiVax™ in larger animal models and human clinical trials."
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