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SNGX: ThermoVax Technology May be the Solution of Developing Heat Stable Ebola Vaccine

By Grant Zeng, CFA


The Ebola Outbreak in Congo

Recently, Congo reported the outbreak of Ebola, with at least 32 suspected, probable or confirmed cases of the disease since April 4, including 18 deaths.

The WHO is moving quickly this time, and hopes to use Ebola vaccine to stem the outbreak in Congo. Basically, the WHO wabts to get approval within days to use a vaccine developed by Merck. While it remains unlicensed—it is being reviewed for approval by the US FDA and other regulators. The vaccine proved to be highly effective in the 2015 trial that involved more than 5,800 people, none of whom developed Ebola nine days or more after vaccination.

Although highly effective, the big problem is that the experimental vaccine must be kept at -60 to -80 degrees Celsius (-76°F to -112°F). This challenges the logistics and greatly increase the costs of transportation.

Soligenix’s ThermoVax Technology may be the Solution of Developing Heat Stable Ebola Vaccine

One possible solution to this problem may be the heat stable vaccine development technology developed by Soligenix (NASDAQ:SNGX), a development stage biotech company focused on developing and commercializing innovative drugs and vaccines to treat/prevent rare diseases. 

Soligenix’s proprietary thermostability technology, ThermoVax®, is a novel method of rendering aluminum salt, Alum, adjuvanted vaccines stable at elevated temperatures. The value of ThermoVax® lies in its potential ability to eliminate the need for cold-chain production, transportation, and storage for Alum adjuvanted vaccines. This would relieve companies of the high costs of producing and maintaining vaccines under refrigerated conditions.

The World Health Organization (WHO) reports that 50% of all vaccines around the world are wasted due to thermostability issues. This is due to the fact that most Alum adjuvanted vaccines need to be maintained at between 2 and 8 degrees Celsius (“C”) and even brief excursions from this temperature range (especially below freezing) usually necessitates the destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question.

In addition to savings realized from the elimination of cold chain costs and related product losses, elimination of the cold chain would also further facilitate the use of these vaccines in the lesser developed parts of the world. On the Vaccines/BioDefense side, ThermoVax® has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency settings.

Proof-of-Concept Data

Proof-of-concept preclinical studies with ThermoVax® indicate that it is able to produce stable vaccine formulations. These studies were conducted with Soligenix’s aluminum-adjuvanted ricin toxin vaccine, RiVax®, made under precise lyophilization conditions. When RiVax® was kept at 400C for one year, all of the animals vaccinated with the lyophilized RiVax® vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax® vaccine kept at 40 degrees C did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees C.

The company also has developed a lyophilized formulation of Ebola vaccine using ThermoVax technology. Animal testing has demonstrated that lyophilization of EBOV-GP formulations did not decrease vaccine potency in mice and immunogenicity of lyophilized formulations was not diminished after high temperature storage.

Near term progress with ThermoVax® will allow Soligenix to seek out potential partnerships with companies marketing FDA/ex-U.S. health authority approved Alum adjuvanted vaccines and/or developing Alum adjuvanted vaccines that are interested in eliminating the need for cold chain for their products. ThermoVax® will further enable Soligenix to expand its vaccine development expertise beyond biodefense into the infectious disease space and also has the potential to allow for the development of multivalent vaccines (e.g., combination ricin-anthrax vaccine).


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