Soligenix Announces Achievement of Two-Year Stability with Bivalent and Trivalent Thermostabilized Filovirus Vaccines when Stored at High Temperatures
|Update : 26th September, 2023|
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced two-year stability of its thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees Celsius (104 degrees Fahrenheit) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This follows the previous successful demonstration of 100% protection of non-human primates (NHPs) against lethal Sudan ebolavirus and Marburg marburgvirus challenge with the bivalent vaccine. This important milestone is part of an ongoing collaboration with the University of Hawaiʻi at Mānoa (UHM), demonstrating the successful presentation of one or more antigen(s) within the same formulation while maintaining full potency and thermostability, including vaccines for Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). It further demonstrates the broad applicability of the heat stable vaccine platform, and its potential role in the United States (U.S.) Administration's initiative for pandemic preparedness.
"Filoviruses such as Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain. There are no licensed vaccines for either Sudan or Marburg viruses, while vaccines for Zaire ebolavirus are constrained by cold chain logistics. A heat stable vaccine in a single vial format would significantly enhance any public health preparedness or response to a new outbreak, at its source," stated Axel Lehrer, PhD, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, UHM. "Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored at temperatures exceeding 100 degrees Fahrenheit. Having a vaccine platform available such as this has the potential to accelerate worldwide vaccination campaigns addressing future health emergencies, including another global pandemic."
"Our next generation combined vaccine platform includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Elements of this vaccine platform have also been utilized in our ricin toxin (RiVax®) and COVID-19 vaccine (CiVax™) candidates, indicating its broad applicability, including at least one-year thermostability at 40 degrees Celsius (104 degrees Fahrenheit). The ability to stably package more than one vaccine candidate in a single vial platform further adds to their developability, whether as a multivalent or individual monovalent vaccine, particularly against Marburg marburgvirus and Sudan ebolavirus where there are currently no available vaccines."
Under the Company's Public Health Solutions business segment, ongoing collaborations with Dr. Lehrer, as well as work conducted by Theodore Randolph, PhD, Professor, Center for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering at the University of Colorado, Boulder have demonstrated the feasibility of developing thermally-stable subunit protein vaccine formulations for filoviruses. The thermostabilized filovirus vaccine program is continuing to advance with the support of a National Institutes of Health (NIH) grant (#R01-AI132323; awarded to the University of Hawaiʻi) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix, Inc.). Work to date has demonstrated the compatibility of lyophilizing both antigen and adjuvant in the same vial, with reconstitution using sterile water for injection immediately prior to vaccination. This simple delivery format, as well as the compatibility with ambient storage, enables vaccines that significantly reduce the logistical hurdles that have been required for addressing the current pandemic or deployment of other Ebola virus vaccines in recent outbreaks in Central and West Africa.
The antigens and adjuvants used in our filovirus vaccines represent the only recombinant subunit vaccines to date that have demonstrated full protection against challenge with Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus in NHPs. Lyophilization of the antigens within monovalent vaccine formulations has also been demonstrated to thermostabilize the antigens at temperatures as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to 12 weeks, enabling transport and storage at ambient temperature, even under challenging conditions. No currently licensed lyophilized vaccine that contains adjuvant is presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations. Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nano-emulsion adjuvant, CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity. This most recent milestone confirms the robust thermostabilization provided by this vaccine platform.
About Filovirus Infection
Ebola Virus Disease is caused by one of six species of Ebolavirus, four of which are known to cause disease in humans, including its best-known member, Zaire ebolavirus (Ebola virus), with Sudan ebolavirus being the second-most common cause of human infection in this family. All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus. Filoviruses are believed to be harbored in various animal species in Africa, particularly bats, although the specific reservoir host for many of these viruses is still unknown. There have been several known Ebola and Marburg Virus Disease outbreaks since 1967, with the largest outbreak starting in 2014 in Western Africa, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of over 11,000 people according to the Centers for Disease Control and Prevention (CDC). These numbers also include some cases of virus introduction and limited spread in Europe and the United States.
Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals. The mortality rates following filovirus infections are extremely high, and, in the absence of wide availability of effective therapeutics, are affected by the quality of supportive care available with a focus on early initiation of treatment. Resolution of the disease largely depends on the patient's own immune system. There are limited treatment options for Ebola Virus Disease and no available treatments for Sudan Virus or Marburg Virus Disease, although steady progress has also been made in development of immunotherapeutics for filoviruses beyond Zaire ebolavirus. There are approved vaccines for Ebola virus (Zaire ebolavirus), requiring stringent ultra-low cold-chain storage, but no efficacious vaccines are yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).
Filoviruses are one of the virus families identified as having the ability to cause pandemics. On the heels of the COVID-19 pandemic the U.S. government is accelerating its investment in pandemic preparedness, including having "the ability to rapidly make vaccines effective against any virus family". Specific initiatives have been spear-headed by the White House and Biden-Harris administration, as evidenced by the "American Pandemic Preparedness: Transforming Our Capabilities" white paper released in September 2021.
About John A. Burns School of Medicine, University of Hawaiʻi at Mānoa
The John A. Burns School Medicine (JABSOM) at the University of Hawaiʻi at Mānoa is one of the leading medical institutions and one of the most ethnically diverse institutions in the United States. For more than a decade, JABSOM has ranked in the top 10% of allopathic medical schools for graduate retention with one of our UH-sponsored residency programs. Hawaiʻi's cultural diversity and geographical setting affords JABSOM a unique research environment to excel in research directed at eliminating diseases that disproportionately affect people in Hawaii and the Pacific region. JABSOM faculty bring in extramural funds of $46 million into the state, annually. In addition, JABSOM was the first U.S. medical school to create a clinical department dedicated to the health and well-being of an indigenous population, Native Hawaiians.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203).
Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
Source : Soligenix, Inc.