SNGX: Bivalent Filovirus Vaccine Candidate Provides 100% Protection in Non-Human Primates…

By David Bautz, PhD

NASDAQ:SNGX

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Business Update

Filovirus Vaccine Candidate Exhibits 100% Protection in Non-Human Primates

On June 24, 2022, Soligenix, Inc. SNGX announced positive results from a study of a bivalent thermostabilized vaccine candidate that resulted in 100% protection in non-human primates (NHPs) following challenge with Marburg marburgvirus (MARV). The vaccine is formulated with antigens from both MARV and Sudan ebolavirus (SUDV), two members of the Filoviridae family (that includes the well-publicized Zaire ebolavirus ‘Ebola virus') that have high mortality rates following infection and few treatment options outside of supportive care. The vaccine is formulated to be stable at temperatures as high as 40°C for up to 12 weeks and only requires reconstitution with sterile water immediately prior to use.

These successful results are a follow-up to previously announced results in which the same vaccine resulted in 100% protection of NHPs that were challenged with SUDV. The fact that the vaccine can offer full protection against two different viruses as a combination product is very encouraging. Both MARV and SUDV are very lethal viruses that can cause outbreaks in areas of the world where access to reliable power sources and distribution channels are sometimes limited. Thus, a heat stable vaccine that can offer protection against both viruses would be an important public health asset that could be utilized to help limit outbreaks.

Filoviruses are one of the virus families recognized as being capable of causing a pandemic, thus effective vaccines against members of that family are clearly warranted. There are currently approved vaccines for Ebola virus (however they require cold-chain storage) and limited treatment options, however no approved vaccines or treatments are available for MARV or SUDV. A number of outbreaks of Ebola virus and MARV have occurred since the mid-20^th century, including one in 2014 that killed >11,000 people (CDC).

In addition to showing that a successful vaccine can be produced against filoviruses, these results serve as an excellent proof-of-concept for the company's vaccine platform, which is capable of producing thermostabilized vaccines targeting multiple antigens that can be stored at temperatures exceeding 100°F. This platform could become quite valuable as a means to accelerate vaccine production against emerging biological threats. President Biden's administration recently requested $82 billion over five years in the proposed 2023 budget, with the goal of being able to produce an effective vaccine against an emerging pathogen within 100 days of its discovery. We believe Soligenix's vaccine platform would be a good candidate for support from such a program.

Conclusion

Investors should view these latest vaccine efficacy results as important for what it represents in terms of the potential of the platform itself, not necessarily just for a filovirus-specific vaccine. The company has continued to generate positive data for vaccines from its platform targeting ricin exposure, filoviruses, and COVID-19, thus we believe the real value lies in the potential to partner with the U.S. government for pandemic preparedness as the U.S. looks to identify ways in which vaccine production can occur as quickly as possible. We look forward to additional updates from the company regarding its vaccine platform, including the potential for outside, non-dilutive funding. With no changes to our model, our valuation remains at $4.00 per share.

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