Biopharmaceutical company Soligenix (OTCBB:SNGX) announced Wednesday further progress in the development of ThermoVax, the company's vaccine thermostabilization technology.
The company's technology allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures.
said Wednesday that progress has been made based on the stability of
prototype vaccines that have been kept at elevated temperatures for
longer than three months.
Studies are being conducted as part of a continuing program to test
the effectiveness of vaccines designed to withstand extremes of
temperature and other environmental stress conditions.
The development of ThermoVax is being supported by a $9.4 million
National Institute of Allergy and Infectious Disease (NIAID) grant, for
biodefense indications against ricin toxin and anthrax exposure.
In February, Soligenix
established proof-of-concept for its thermostabilization technology
using its aluminum-adjuvant ricin toxin RiVax vaccine. Results from this
study showed the vaccine retained effectiveness and potency, while
stored at 40 degrees Celsius for one month, when combined with the
ThermoVax technology, the company said.
Confirmatory results, Soligenix added, have now extended this initial time frame to more than three months when the vaccine is kept at 40 degrees Celsius.
In contrast, the liquid RiVax vaccine, when stored at 40 degrees
Celsius, rapidly degraded and no longer maintained its effectiveness,
the company said. This is because the ricin A chain is typically
sensitive to temperature and quickly loses its ability to induce
neutralizing antibodies when exposed to higher temperatues than 8
But ThermoVax is able to produce "stable and potent" vaccine formulations, Soligenix
said, by combining lyophilzation technology with conventional aluminum
adjuvants, secondary adjuvants (for rapid onset of immunity), and
The lyophilization process is often employed to extend the shelf life
of drugs, by removing the water from the pharmaceutical preparation.
Vaccines that undergo this process often lose their potency, especially
if the vaccine is made with aluminum salt adjuvants, as most are.
As a result, most vaccine products must be kept under tightly
controlled conditions, as the World Health Organization (WHO) estimates
that about half of all global vaccine doses are wasted for not being
kept within required temperature ranges.
technology, however, achieves this lyophilization effect but maintains
the sensitive material in the vaccine, making the technology especially
valuable for biodefense or pandemic situations, where drugs need to be
stockpiled for a long period of time.
"We continue to be pleased with the data generated thus far with ThermoVax," said chief scientific officer, Dr. Robert N. Brey.
"The ability of vaccines to withstand extreme temperatures is a significant step forward in vaccine technology.
"ThermoVax may also enable preparation of otherwise difficult
multivalent (protective against multiple pathogens) formulations. We
plan to apply ThermoVax to other conventional vaccines that require
The underlying technology was developed by Drs. John Carpenter and
Theodore Randolph at the University of Colorado, whose team performed
the studies along with Dr. Nicholas Mantis of The New York State
Department of Health in Albany.
The company said the elimination of the cold chain would also boost
the utility of these vaccines for emerging markets, and for other
applications requiring but lacking reliable cold chain capabilities,
which add considerable cost.
is a development stage biopharmaceutical company, developing products
to treat life-threatening side effects of cancer treatments and serious
gastrointestinal diseases, as well as vaccines for certain bioterrorism
Through its biodefense division, Soligenix
is developing its SGX204 vaccine, which is designed to protect against
the lethal effects of exposure to anthrax, in addition to RiVax.