UH Med Now
COVID-19 vaccine candidate demonstrates broad neutralizing antibody response against Beta, Gamma, Delta variants
‘A single-vial, subunit vaccine that can be shipped at ambient temperatures and can be reconstituted with sterile water immediately before use has the potential to bolster global vaccination efforts by simplifying storage and distribution,’ – Axel Lehrer, PhD
Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced this week release of a preprint demonstrating advanced preclinical immunogenicity studies for CiVax™ (heat-stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses, including against the Beta, Gamma and Delta variants.
The article, ‘Protein Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in Macaques than Natural Infection with SARS-CoV-2 P.1,’ has been posted as an accelerated preprint on bioRxiv. This work is part of an ongoing collaboration between the laboratory ofAxel Lehrer, PhD, Associate Professor at the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa and Soligenix. Development continues under a $1.5M Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases awarded to Soligenix (Nasdaq: SNGX) in December 2020.
Said Lehrer: “We continue to advance our work using our vaccine platform, consisting of a robust protein manufacturing process and a thermostabilizing formulation using the Soligenix ThermoVax® process and the CoVaccine HT™ adjuvant. The CiVax™ vaccine has demonstrated broad and robust immune responses in mice, which has now further been demonstrated in nonhuman primates and also shown to yield protection against infection with a COVID-19 variant of concern (the Gamma variant)”. It further demonstrated that a broad protection can be expected against all major variants of concern including the currently circulating Delta variant.
“Our work with CiVax™ emerged from our ongoing efforts to develop heat-stable, single-vial format vaccines for filoviruses such as Ebola. The ability to rapidly pivot from filovirus to SARS-CoV-2 demonstrates the broad applicability of this platform and our productive collaboration with Soligenix,” Lehrer said. “A single-vial subunit vaccine that can be shipped at room temperature and that need only be reconstituted with sterile water immediately prior to use has the potential to bolster the global vaccination efforts by simplifying storage and distribution logistics.”
While a number of vaccines are available worldwide, the requirement for cold-chain shipping and timely administration, coupled with manufacturing scale-up logistics, have limited the world’s supply of vaccines against the virus and variants that cause COVID-19. Rapid vaccine administration worldwide is necessary to curtail disease spread and to slow or pre-empt evolution of mutations, which may significantly reduce the effectiveness of current vaccine approaches. Previous work with the novel CoVaccine HT™ adjuvant has indicated that it can be thermostabilized both alone and in combination with antigens, potentially yielding a single-vial presentation of CiVax™, which would not require cold chain distribution or storage.
Paula Bender, UH MedNewsNow