SuVax™ and MarVax™ Thermostable Vaccine Platform to be Presented at the Vaccine Technology IX Conference
Soligenix announced that Professor Axel Lehrer from the University of Hawaiʽi will present data on their thermostable vaccine technology at the Vaccine Technology IX Conference in Los Cabos, Mexico, from May 19-24, 2024. The technology includes filovirus vaccine candidates SuVax™ and MarVax™. The presentation will cover the optimization of vaccine formulation focused on safety and thermostability. Soligenix's vaccines, developed under their Public Health Solutions segment, use GRAS excipients and lyophilization for stability, protecting against Sudan ebolavirus and Marburg marburgvirus in non-human primate studies. The company has received Orphan Drug Designation for these vaccines.
- Presentation at a reputable conference could increase visibility and credibility.
- Successful preclinical results in non-human primate studies.
- Orphan Drug Designation granted for Sudan ebolavirus and Marburg marburgvirus vaccines.
- Thermostable technology could offer logistical advantages in vaccine distribution.
- No mention of human clinical trial data or timelines.
- Details of financial impact or funding for further development not disclosed.
- Dependence on successful clinical trials for future business growth.
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
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
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
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
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
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,
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
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
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 successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. 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 (SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes 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).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the
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SOURCE SOLIGENIX, INC.
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