Soligenix Inc. (NasdaqCM: SNGX) earned the spotlight after announcing positive pre-clinical results for its novel COVID-19 vaccine candidate. The Tuesday publication of pre-clinical immunogenicity studies for its CiVax™ program (heat-stable COVID-19 vaccine), demonstrated that immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ adjuvant. The article, authored by collaborators at the University of Hawaii at Manoa (UHM), is titled, "CoVaccine HT™ 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 is available here

CiVax™ is a heat-stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. The candidate is a product of ongoing collaborations with Axel Lehrer, Ph.D., Assistant Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, UHM evaluating the feasibility of developing a broadly immunogenic vaccine for COVID-19. 

The team is leveraging significant worldwide research dedicated to the generation of COVID-19 vaccines, focusing on the essential attributes of a successful vaccine having the ability to control the spread of viruses from an ability to rapidly stimulate a balanced antibody response. Those responses include the need for an enhanced Th1 response to raise significant virus-neutralizing antibodies and potent cell-mediated immunity, demonstrated by T-cell activation. Soligenix has shown in previous work with the CoVaccine adjuvant, licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), an indication that its CoVaccine candidate has these critical characteristics.

Most notably, Soligenix points to Lehrer and his colleagues now demonstrating these attributes, specifically in the context of SARS-CoV-2. Their data supports using a protein subunit prototype antigen, which shows a rapid onset of immunity with antibody responses detected within 14 days after the first vaccination. Perhaps most important, preliminary indications suggest that the responses may be strong enough to allow for a single dose of its vaccine candidate.

Finding An Effective Vaccine May Require Collaboration 

Despite the global population being respectful of the many programs seeking a vaccine for COVID-19, it's apparent that 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 may require parallel and collaborative approaches. 

Further, based on the expected total number of vaccine doses required to control the ongoing pandemic, experts are suggesting the need for multiple vaccines, based on different manufacturing platforms, will be necessary to efficiently vaccinate the worldwide population. This opens the opportunity for subunit vaccines, which are considered the gold standard for vaccine safety but remain relatively underrepresented in fast-tracked COVID-19 vaccine candidates. However, Soligenix may inspire change. 

Soligenix points out that 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. That's in contrast to RNA and DNA vaccines that, despite their speed to manufacture, lack regulatory precedent (no RNA or DNA vaccine has been approved to date). Soligenix, though, through its collaborative studies, has demonstrated not only the feasibility of rapid and efficient manufacturing of the required vaccine antigens but also the potential for a broadly applicable, safe, and easily distributed vaccine. 

Moreover, results in the latest published manuscript confirm that the advantages of its vaccine platform using the CoVaccine adjuvant can also be realized in the context of SARS-CoV-2. Additionally, the vaccine candidate can benefit from a heat-stable subunit COVID-19 vaccine in collaboration with Soligenix's ThermoVax® technology. 

Importance Of Enhanced Vaccine Stability

The significance of creating a vaccine with enhanced stability at elevated temperatures can be vital to keeping a vaccine potent during global distribution. It can further obviate the costs and logistical burdens associated with cold chain storage and distribution, providing the potential to offer a distinct advantage over other COVID-19 vaccines currently in development. 

Having that technology makes Soligenix unique in its use of a well-established, well-understood, and safe, subunit platform coupled with a novel adjuvant and a thermostabilizing formulation. The latest results are encouraging and show that the company may be well-positioned to meet many of the challenges of developing and bringing a safe, effective, and viable COVID-19 vaccine to market. Its development of CiVax™ may indeed be answering an urgent call from the global population.

Soligenix trades on the NASDAQ Capital Markets under the symbol SNGX.


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