Marburg Virus Disease

Dr. Tedros Adhanom Ghebreyesus was speaking at a panel discussing how healthcare systems should prepare for “Disease X”, at the ongoing World Economic Forum (WEF) being held in Davos. Image credit: GettyImages/Bloomberg. “Narrow national interest should not come in the way” of fighting against the next big public health threat, says World Health Organisation (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus. The WHO chief was talking at a panel discussing how healthcare systems should prepare for “Disease X”, at the ongoing World Economic Forum (WEF) being held in Davos. Disease X refers to the next international epidemic caused by an unknown pathogen. The term was created by the WHO in 2018 to help facilitate sufficient planning and preparedness to sustain public health in the face of the next big viral threat. Disease X is on the WHO’s priority disease list alongside diseases such as Zika, Covid-19, Ebola virus disease and Marburg virus disease. The priority list is meant to direct global investment and intensify research and development (R&D) in those areas. “We have to convert all the lessons we have learned into this [next] pandemic and prepare the world for the future because this is a common global interest,” Ghebreyesus said. Ghebreyesus’ main message was that of addressing equity and ensuring collaboration to fight “a common enemy.” Covid-19 vaccine inequity is difficult to ignore – during the first seven months of the Covid-19 vaccination campaign, more than 80% of the doses were concentrated in high and upper-middle income countries. The WHO chief reiterated the importance of The Pandemic Treaty – an international agreement that would bring countries together to fight Disease X and any other future pandemics. “Many high-income countries were hoarding vaccines [during the Covid-19 pandemic] and low-income countries were not getting vaccines. Access was a problem.” The treaty is known also as The Pandemic Agreement or Accords and countries have until May 2024 to join. “I hope [The Pandemic Agreement] will be delivered by that time. If this generation cannot do it, who have first-hand experience, I don’t think the next generation will.” It will not be an easy road to securing a substantial amount of WHO member country signatures. Officials have been negotiating  the terms for over a year. There is a clear divide in the US, for example, where the opposition Republican party has been openly against the agreement – saying the WHO would acquire additional power.  The outcome of the upcoming presidential election in 2024 will likely have implications for the US stance on the treaty. The international non-profit Human Rights Watch has also called on the member states to push for commitments to protect core human rights in the agreement. Pharma companies have been wary of the treaty and its stance on allowing intellectual property waivers when applicable. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in a statement that this approach to inducing equity would conversely lead to innovation pipelines being stalled. Ghebreyesus has previously called out critics of the pandemic accords and highlighted the role of “vested interests” in driving this disapproval. The WHO has already taken several steps to build a framework in place to tackle the next unknown pathogen. In 2022, the organisation helped set up The Pandemic Fund with the World Bank to enhance preparedness in low- and middle-income countries. In a further bid to address health inequity seen during the Covid-19 pandemic, an mRNA technology transfer hub has been set up in South Africa to increase local production. Virus surveillance and early warning systems are also being advanced. Research indicates that Covid-19 would have caused 40 million more deaths in the absence of preventative measures. “The key is the capacity we build in each and every country. We’re as strong as the weakest link,” Dr Tedros added. AstraZeneca ’s chairman Michel Demaré, Philips’ CEO Roy Jakobs, Apollo Hospitals’ vice chairperson Preetha Reddy, and Brazil’s health minister Nisia Trindade Lima were also on the panel.

Single-vial thermostabilized bivalent vaccine demonstrates simultaneous protection against two lethal viruses PRINCETON, N.J., Jan. 2, 2024 /PRNewswire/ -- 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 a publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections. In collaboration with University of Hawaiʻi at Mānoa (UHM), the manuscript entitled "Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection", has been published in Vaccine. This vaccine candidate has been previously demonstrated to be stable to high temperature storage for at least 2 years at 40 degrees Celsius (104 degrees Fahrenheit). There are currently no approved vaccines or therapeutics for either SUDV or MARV infections. Vaccines are available for Zaire ebolavirus (EBOV) infections but they provide no protection against SUDV or MARV infection. The published paper describes the potency of the bivalent formulation against both viruses, demonstrating 100% protection in the most rigorous non-human primate challenge models. "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. A thermostabilized vaccine in a single vial format would significantly enhance any public health 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 for extended times at temperatures exceeding 100 degrees Fahrenheit. The use of a bivalent vaccine has the potential to both prevent future infections with these pathogens and potentially mitigate future outbreak events, potentially using an accelerated dosing regimen." "Our combined vaccine platform includes 3 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 antigens in a single vial," stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Elements of this vaccine platform have been utilized in our ricin toxin, filovirus and COVID-19 vaccine candidates, indicating its broad applicability. The ability to package the vaccine candidates in a single vial 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 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 Institute of Health (NIH) grant R01-AI132323 (awarded to UHM) 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 with sterile water for injection immediately prior to use. 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. 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 genus. 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 that involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of more than 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. In 2022 and 2023 several SUDV and MARV outbreaks were observed in continental Africa. 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 yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus). About John A. Burns School of Medicine, University of Hawai'i at Manoa 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 (SGX945) in Behçet's Disease. The Company also is developing proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation such as 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, Sudan 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 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 U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Despite the positive efficacy results demonstrated in the Phase 2 and 3 clinical studies of SGX942 for the treatment of oral mucositis due to chemoradiation therapy for head and neck cancer, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. Company Codes: NASDAQ-SMALL:SNGX

WASHINGTON, Oct. 19, 2023 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute has launched a Phase 2 clinical trial for its vaccine candidate against the lethal Marburg virus. Healthy volunteers received the single-dose vaccine at Makerere University Walter Reed Project (MUWRP) in Kampala, Uganda today. There are currently no vaccines or antiviral treatments approved to treat Marburg virus disease. Marburg is a filovirus, in the same family as the virus that causes Ebola. Like Ebola, Marburg virus disease spreads between people via direct contact with the blood or other bodily fluids of infected people, is highly virulent, and causes hemorrhagic fever. The disease has a fatality rate of up to 88%. Based on the ChAd3 platform, Sabin’s single-dose investigational Marburg vaccine was found to be promising in Phase 1 clinical and non-clinical studies, with results showing it to be safe, while eliciting rapid and robust immune responses. Dr. Betty Mwesigwa, deputy executive director of MUWRP, is the principal investigator for the Kampala portion of the Sabin-sponsored trial. Participants will also be enrolled a few weeks later at a second site at the Kenya Medical Research Institute in Siaya, Kenya, with Dr. Videlis Nduba as principal investigator. In all, 125 volunteers will participate in the trial. “We have an extraordinary opportunity here to improve our preparedness to save lives and protect people from a deadly and unforgiving disease that typically strikes under-resourced countries first and most,” says Amy Finan, Sabin’s Chief Executive Officer. “Sabin’s Phase 2 clinical trial builds on a solid safety and immunogenicity foundation and we are hoping it will generate the information needed to move the vaccine toward licensure.” The number of Marburg outbreaks in Africa has climbed steadily in recent years. Two outbreaks of Marburg virus disease have occurred already this year: Equatorial Guinea reported its first ever documented Marburg outbreak, which killed 12 people, followed by Tanzania, where six people succumbed to the virus. Communities in Uganda and Kenya are familiar with Marburg virus disease, having been ravaged by outbreaks over multiple years in the last few decades. “Makerere University Walter Reed Project (MUWRP) is delighted to partner with the Sabin Vaccine Institute to launch the clinical testing for a preventive Marburg vaccine,” says Dr. Mwesigwa. “Most Marburg virus disease outbreaks have originated in Africa. Uganda alone has registered 4 outbreaks of the disease. We urgently need a vaccine against Marburg because of its potential to cause epidemics with significant death rates. It is imperative for us to test candidate vaccines in Uganda, a country prone to these outbreaks. This work will contribute new knowledge to inform the scientific discovery for an effective vaccine against the deadly Marburg virus.” The Phase 2 clinical trial for Sabin’s Marburg vaccine will continue to evaluate safety and immunogenicity for the vaccine, this time among a larger group of individuals. This is a randomized, placebo-controlled, double-blind study, meaning that neither the participants nor the researchers will know whether trial participants receive a vaccine dose or a placebo dose until after the trial is over, an approach used to help reduce experimental bias. Participants in the clinical trial will be monitored for a full year and will include both younger (18-50 years) and older age groups (51-70 years). Interim results are expected next year. In addition to the current trial in Uganda and Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Marburg in the U.S. The Marburg vaccine trials are supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under multi-year contracts between the organizations, including most recently a $36.4 million award for vaccine development and production. Similarly, BARDA has invested in Sabin for advancing ChAd3 Sudan ebolavirus vaccine candidate, including awarding $28 million this August for Phase 2 clinical trials in the U.S. To date, Sabin has received around $215 million in contract awards from BARDA for furthering vaccine research and development against Sudan ebolavirus and Marburg virus diseases. BARDA and Sabin began working together in September 2019 to develop the two monovalent vaccine candidates. Sabin’s Sudan ebolavirus vaccine candidate was the first to arrive in Uganda last year during the disease outbreak that left 55 people dead. Sabin has also initiated plans for a Phase 2 Sudan ebolavirus vaccine clinical trial in Uganda and Kenya. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010. About the Sabin Vaccine Institute The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.About Sabin’s Vaccine R&D Using the ChAd3 Platform. About Sabin’s Vaccine R&D Using the ChAd3 Platform In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary ChAd3 platform, were further developed by GSK, including the Phase II development for the Ebola Zaire vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. About the Makerere University Walter Reed Project MUWRP is a non-profit biomedical research organization with a mission to mitigate disease threats through quality research, health care and disease surveillance. The project’s scope includes among others; clinical research in infectious and non-infectious diseases such as HIV, Ebola, Marburg, COVID-19, Influenza and Influenza-like illnesses, and neglected tropical diseases such as Schistosomiasis, among others. A major part of the clinical research are clinical trials, where the MUWRP has conducted more than 12 phase I and II vaccine clinical trials including the first Ebola vaccine trial in Africa. Media Contact: Monika Guttman Media Relations SpecialistSabin Vaccine Institute +1 (202) 662-1841 press@sabin.org A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0ecbc982-493a-4ecf-9393-e203708aa3ea