Benzinga | Jul 28, 2020 07:08AM EDT

Soligenix Highlights Publication Of Pre-Clinical Results Of Novel Coronavirus Vaccine: Rapid Immune Responses Showed With CoVaccine HT Adjuvant In Prototype Vaccine, Saw Neutralizing Antibodies, Th1 Antibody, Cell Mediated Responses Established

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 its CiVax(tm) program (heat stable COVID-19 vaccine), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT(tm) (CoVaccine) adjuvant. The article, authored by collaborators at the University of Hawaii at Mnoa (UHM), is titled, "CoVaccine HT(tm) adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here.

CiVax(tm) 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, Assistant Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM have demonstrated the feasibility of developing a broadly immunogenic vaccine for COVID-19. With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a balanced antibody response, including an enhanced Th1 response, which includes raising significant virus neutralizing antibodies and potent cell-mediated immunity, demonstrated by T-cell activation. Previous work with the CoVaccine adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine has these critical characteristics. In these results, Lehrer and his colleagues now demonstrate these attributes of CoVaccine, specifically in the context of SARS-CoV-2. Moreover, these results, using a prototype antigen, also demonstrate a rapid onset of immunity with antibody responses detected within 14 days after the first vaccination.

Many programs have been initiated seeking a vaccine for COVID-19, but the novelty of the virus and previous challenges developing potent vaccines for the related SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus) and MERS-CoV (Middle East Respiratory Syndrome Coronavirus), suggest that a timely solution requires parallel approaches. The total number of vaccine doses required to control the ongoing pandemic also suggests that multiple vaccines, based on different manufacturing platforms, will be necessary to efficiently vaccinate the worldwide population. Subunit vaccines are considered the gold standard for vaccine safety, but are relatively under-represented in fast-tracked COVID-19 vaccine candidates to date. Unlike virally vectored vaccines, there is no limit to the number of times the adjuvant and antigen can be used and the typical safety profile of a subunit vaccine results in a vaccine that is suitable for immune compromised or elderly populations as well. In contrast, while RNA and DNA vaccines are rapid to manufacture, there is a lack of regulatory precedent (no RNA or DNA vaccine has been approved to date).

"Our work to date has demonstrated not only the feasibility of rapid and efficient 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 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."

"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 provide a distinct advantage over other COVID-19 vaccines currently in development and simplifies worldwide distribution," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "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(tm)."