Axel Lehrer in his lab at the University of Hawai‘i medical school. Photo by Jessica Henao

Axel Lehrer in his lab at the University of Hawai‘i medical school. Photo by Jessica Henao

A second partner has announced the University of Hawai‘i’s efforts to develop a heat-stable (without cold-storage requirement) vaccine against the deadly Ebola virus, as reported by UH this past week.

Soligenix, Inc., a late-stage biopharmaceutical company developing products addressing unmet medical needs in the areas of inflammation, oncology and biodefense, announced Thursday a collaboration agreement with Axel Lehrer, PhD, of the UH Mānoa Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine; and Hawaiʻi Biotech Inc. to develop a heat-stable subunit Ebola vaccine.

Lehrer, a co-inventor of the Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates. Under the terms of the feasibility agreement, Soligenix will evaluate its proprietary vaccine thermostabilization technology, ThermoVax™, licensed from the University of Colorado, to stabilize components of the vaccine. Ultimately, the objective is to produce a thermostable Ebola vaccine for worldwide distribution that does not require cold storage.

ThermoVax™ has been previously demonstrated to enhance thermostability of both ricin (RiVax™) and anthrax (VeloThrax™) subunit vaccines. The initial work on the potential Ebola vaccine will focus on a single protein subunit antigen.

Source: Ebola Hemorrhagic Fever, Centers for Disease Control and Prevention. Graphic by Mikael Häggström

Source: Ebola Hemorrhagic Fever, Centers for Disease Control and Prevention. Graphic by Mikael Häggström

The most advanced Ebola vaccines involve the use of vesicular stomatitis virus (VSV) and adenovirus vectors — live, viral vectors that complicate the manufacturing, stability and storage requirements.

Lehrer’s vaccine is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Lehrer and HBI have developed a robust manufacturing process for the required proteins. Application of ThermoVax™ may allow for a product that can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world.

“There is a great need for a thermostable Ebola vaccine, particularly in areas of the world where Filoviruses are endemic and the power supply uncertain,” Lehrer said. “We are delighted to pursue this feasibility work with Soligenix and look forward to a long and productive collaboration.”

“Coupling Soligenix’s thermostabilization technology with Hawaiʻi Biotech’s robust manufacturing processes is likely to yield a much needed vaccine to add to the world’s arsenal against infectious disease and we look forward to working with both Soligenix and JABSOM,” said Dr. Elliot Parks, President and Chief Executive Officer of HBI.

“We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other Ebola vaccines currently in development,” said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We are continuing to develop ThermoVax™ using RiVax™, our proprietary ricin vaccine, under a recent National Institute of Allergy and Infectious Diseases (NIAID) contract award of up to $24.7 million over 6 years. We intend to apply this same technology beyond biodefense to emerging infectious diseases and see this collaboration with UH Mānoa and HBI to be an important next step in demonstrating the broad applicability of this technology.”

About Ebola

Graphic by Centers for Disease Control

Graphic by Centers for Disease Control

Ebola Virus Disease (EVD) is caused by one of five species of Ebolavirus, four of which cause disease in humans, including its best-known member, Zaire Ebolavirus (Ebola virus). All species of Ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburgvirus. The Ebola virus is believed to be harbored in various animal species in Africa, although the specific reservoir host is still unknown. There have been several known EVD outbreaks in Africa since 1976, with the most recent and largest outbreak starting in 2014 in Western Africa.

Transmission of Ebola requires direct contact of bodily fluids from an infected person or contact with infected animals. The mortality rate from Ebola infection is extremely high, and can sometimes be affected by the quality of supportive care available with a focus on early initiation of treatment. Symptoms of Ebola virus infection include high fever, severe headache, muscle pain, weakness, fatigue, diarrhea, vomiting, abdominal pain and unexplained hemorrhage. Resolution of the disease largely depends on the patient’s own immune system. There is no approved treatment and no approved vaccine for Ebola, although research into both has accelerated since the onset of the 2014 outbreak.

The Ebola outbreak in 2014 primarily spanned three West African countries, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of 10,892 people as of May 1, 2015, according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States. The widespread nature of the infection and its devastating impact has further illustrated the need to develop an Ebola vaccine to prevent future and possibly more significant outbreaks.

About ThermoVax™

ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities. Further, the World Health Organization (WHO) reports that 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges. NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency situations.

The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. RiVax™ and VeloThrax™ are extremely labile in their liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit). By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.

The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of a cooperative grant from NIAID.

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