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Princeton, NJ – May 21, 2024 – Soligenix, Inc. (Nasdaq: SNGX) (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 today thatProfessor Axel Lehrer, University of Hawaiʽi at Mānoa (UHM), will be presenting key data from the Company’s thermostable vaccine technology platform developed in collaboration with UHM, including results from the filovirus vaccine candidates for both Sudan ebolavirus (SuVax™) and Marburg marburgvirus (MarVax™). The presentation will be given at the upcoming Vaccine Technology IX, Los Cabos, Mexico, May 19-24, 2024.
Oral Presentation:
Formulation optimization focused on safety and thermostability of a single-vial bivalent Sudan Ebola virus and Marburg Virus Vaccine presented by Professor Axel Lehrer, University of Hawaiʽi at Mānoa on May 22, 2024 from 4:15-4:30 pm. The official conference program can be found here.
Under the Company’s Public Health Solutions business segment, Soligenix is developing thermostabilized subunit vaccines. Thermostabilization is achieved by using a combination of Generally Recognized as Safe (GRAS) excipients and lyophilization (freeze-drying) to yield a single-vial presentation of vaccine that is stable at ambient and higher temperatures and that can be reconstituted with water for injection immediately prior to use. Mono-, bi- and tri-valent vaccine candidates for filoviruses (including Sudan ebolavirus and Marburg marburgvirus) have demonstrated complete protection in non-human primate challenge studies using thermostabilized formulations. Soligenix has recently been granted Orphan Drug Designation for the prevention and post-exposure prophylaxis against both Sudan ebolavirus and Marburg marburgvirus.
About the Vaccine Technology IX Conference
The Vaccine Technology Conference focuses on the discovery, development and manufacture of vaccines. It connects global experts in the vaccine field to discuss and address the technologies to advance vaccines for global needs. The conference offers high-quality scientific content from leaders in academia, industry, government and not-for-profit global health organizations that share a common goal – Advancing Vaccine Technologies for a Healthier World. More information about the conference, and registration to attend can be found here.
About SuVax™
SuVax™ is a subunit protein vaccine of recombinantly expressed Sudan Ebola virus glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa. The vaccine includes a protein found on the surface of Sudan ebolavirus (SUDV), to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with Generally Regarded as Safe (GRAS) excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use. SuVax™, as a heat stable protein subunit vaccine, has protected 100% of non-human primates exposed to a lethal injection of SUDV. Stability studies have demonstrated that SuVax™ is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit).
Manufacture of the recombinant protein utilized in SuVax™ utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies. SuVax™ can also be used as part of a multivalent vaccine, in combination with antigens against Marburg marburgvirus (MARV) for example.
Soligenix has been granted Orphan Drug Designation by the United States Food and Drug Administration for the prevention and post-exposure prophylaxis against Sudan ebolavirus infection. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.
About MarVax™
MarVax™ is a subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa. The vaccine includes a protein found on the surface of MARV, to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with Generally Regarded as Safe (GRAS) excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use. Stability studies have demonstrated that MarVax™ is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit). MarVax™ has demonstrated 100% protection of non-human primates exposed to a lethal injection of MARV.
Manufacture of the recombinant protein utilized in MarVax™ utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies. MarVax™ can also be used as part of a multivalent vaccine, in combination with antigens against Sudan ebolavirus for example.
Soligenix has been granted Orphan Drug Designation by the United States Food and Drug Administration for the prevention and post-exposure prophylaxis against Marburg marburgvirus infection. In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits.
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 (both Sudan and Zaire) and Marburg Virus Disease outbreaks since 1967. The most recent SUDV outbreak occurred in August – October, 2022 in Uganda according to the Centers for Disease Control and Prevention (CDC). The most recent MARV outbreaks occurred in February – June 2023 in Equatorial Guinea and in March – May 2023 in Tanzania, with no relationship between the two outbreaks, according to the Centers for Disease Control and Prevention (CDC). Cases of Marburg Virus Disease were also recorded in Ghana in 2022 and 2021.
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 US 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 Hawaiʽi 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 an 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.
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