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Soligenix publishes a publication demonstrating thermal stabilization of filovirus vaccine antigens. news



Princeton, NJ, September 15, 2020 / PRNewswire /-Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or Company) is a late-stage biopharmaceutical company focused on developing and commercializing products for the treatment of rare diseases with unmet medical needs. In a nonclinical study published today, the results characterizing filovirus protein antigens (including Ebola and Marburg viruses) and their thermal stabilization. Articles written by co-editors of University of Colorado, University of Hawaii at Manoa (UHM) and Soligenix, entitled “Conservation of quaternary structures in thermostable cryodried filovirus glycoprotein vaccines: Search for stable assays” Journal of Pharmaceutical Sciences. A copy of the manuscript is now available here..

Under our Public Health Solutions Business Segment Axel teacher, PhD, Associate Professor, Tropical Medicine, Medical Microbiology and Pharmacology, John A Burns School of Medicine (JABSOM), UHM and Hawaii Biotech Inc. (HBI), and Theodore Randolph, Ph.D., Pharmaceutical Biotechnology Center, Department of Chemical Biotechnology, University of Colorado at Boulder Demonstrated the feasibility of developing a thermostable subunit protein vaccine formulation for filovirus vaccines. It has been demonstrated to protect against Ebola virus infection in non-human primates. Sudan Virus, and Marburg virus. It has been confirmed that the formulation conditions can be heat-stabilized at 40 degrees Celsius (104 degrees Fahrenheit) for at least 12 weeks, either alone or in combination. These latest results show the thermal stabilization of three viral glycoproteins ( Zaire Ebola virus, Sudan Ebola virus And Marburg virus Marburg virus), And identification of assays that show key stability to further support monovalent, divalent, and trivalent vaccine formulations.

“Filoviruses are endemic in regions of the world with uncertain power sources, making thermostable vaccines particularly valuable,” said Dr. Lehrer. “Our research so far has shown that not only is the possibility of rapid and efficient production, but also the applicability of heat stabilization and the potential of a widely applied and easily distributed vaccine. Marburg virus is the United States. It is accelerating with a particular focus on the evaluation of Marburg virus vaccines as it continues to be a priority and yet unmet medical need for the government. “

“Continuous progress in the filoviridae program demonstrates the maturity and overall development potential of the program,” said Dr. Oleoradnini, Senior Vice President and Chief Scientific Officer of Solidenix. “The identification of assays that show compatibility with heat stabilization and key stability are both features of a vaccine platform that has the potential for widespread application. Using this platform, a joint COVID called CiVax ™ -19 We look forward to the vaccine efforts, Dr. Lehrer, and the further development of both programs. “

About filovirus infection

Ebola virus disease is caused by one of six types of Ebola virus. Four of them, including the most famous members, are known to cause disease in humans. Zaire Ebola virus (Ebola virus). All species of Ebola virus belong to the family Filoviridae, a family that also includes the human pathogenic Marburg virus. Filoviridae are believed to be lurking in various animal species Africa, Especially bats. However, many specific hosts for these viruses are still unknown. Several viral infections of Ebola and Marburg viruses have been reported since 1967, with the largest outbreak in 2014. West AfricaAccording to the Centers for Disease Control and Prevention (CDC), more than 26,000 confirmed / estimated / suspected cases were involved, with an estimated death toll of over 11,000. Europe And America..

Infection with filovirus requires direct contact with the body fluids of the infected person or contact with the infected animal. Mortality from filovirus infections is very high and can be affected by the quality of supportive care that focuses on early initiation of treatment. Elimination of the disease is highly dependent on the patient’s own immune system. There is no approved treatment for Ebola or Marburg, but since its outbreak in 2014, both studies have accelerated and significant progress has been made in advanced clinical trials of immunotherapy. Zaire Ebola virus.. There is an approved vaccine and the Ebola virus must be stored below -60 ° C (Zaire Ebola virus), But the Marburg virus (Marburg virus Marburg virus) Or Sudan Virus (Sudan Ebola virus).

about John A Burns School University of Hawaii at Manoa School of Medicine

The University of Hawaii at Manoa is one of the most diverse ethnic higher education institutions. Hawaii’s cultural diversity and geographical environment provide JABSOM with an excellent and unique research environment for health inequalities research. JABSOM faculty bring about external funding $ 40 million To Hawaii every year.

About Hawaii Biotech

Hawaii Biotech (HBI) is a non-profit biotechnology company focused on developing prophylactic vaccines against established and emerging infectious diseases and antitoxin drugs against biological threats. HBI has developed its own expertise in the production of safe and effective vaccines, diagnostic kits, and recombinant proteins for use as research tools. HBI has successfully completed the first Phase 1 clinical trial in humans with both West Nile virus and dengue vaccine in healthy humans. HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates such as West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola. The company is also continuing to develop small molecule antitoxins for anthrax and botulism. Established in HBI Hawaii Headquartered in 1982 in Honolulu. See below for more information.

About Soligenix, Inc.

Soligenix is ​​a late-stage biopharmacy company focused on developing and commercializing products to treat rare diseases with unmet medical needs. Our Specialized Biotherapeutics business segment is developing SGX301 as a new photodynamic therapy for the treatment of cutaneous T-cell lymphoma using safe visible light. This is the best-in-class Natural Defense Regulator (IDR) technology, dusquetide (SGX942) for oral treatment. Oral beclomethasone 17,21-dipropion for the prevention / treatment of head and neck cancer mucositis and gastrointestinal (GI) disorders characterized by severe inflammation such as childhood Crohn’s disease (SGX203) and acute radiation enteritis (SGX201) A unique formulation of acid (BDP).

Our public health solutions business segment includes the aggressive development program of RiVax®, a candidate for lysine toxin vaccine, SGX943, a candidate for treatment of antibiotic resistance and emerging infectious diseases, and filoviruses (such as Marburg and Ebola). Includes a vaccine program that targets both coronaviruses. The development of our vaccine program incorporates the use of a unique heat stabilization platform technology known as ThermoVax®. To date, this business segment has been supported by government grants and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Agency (BARDA), and the Defense Threat Reduction Agency (DTRA). It was.

For more information on Soligenix, Inc., please visit the following company websites:

This press release includes, but is not limited to, potential market size, patient numbers, and enrollment in clinical trials, and Solidenix, Inc.’s current expectations for its future results, performance, prospects, and opportunities. May contain outlook information that reflects. Historical such as “expectation”, “estimation”, “believe”, “expect”, “intention”, “plan”, “expect”, “goal”, “may”, “suggest” Non-factual statements “”, “possibility”, or similar expressions are forward-looking statements. These statements have some risks that the actual event or future outcome may differ materially from what is expressed or implied in these statements, such as those experienced at the COVID-19 outbreak. , Uncertainty, and other factors. Soligenix develops products and regulatory approvals based on its technology, especially in light of the significant uncertainties inherent in developing treatments and vaccines against the threat of bioterrorism, conducting preclinical and clinical trials of treatments. Or we cannot guarantee that the commercialization will be successful. Vaccines that manufacture treatments and vaccines with regulatory approval, their product development and commercialization efforts due to difficulties or delays in clinical trials, or advances or positive results from research and development efforts. Due to lack, it will not be reduced or discontinued. Succeeded in raising additional funding to support product development and commercialization efforts, including grants and awards, maintaining existing grants subject to performance requirements, and living with the US Government or other countries Conclude a defensive procurement contract. Can compete with larger and better funding competitors in the biotechnology industry, changing healthcare practices, third-party reimbursement restrictions, federal and / or state healthcare reform initiatives will not adversely affect business, Or a law that provides additional funding for the Project BioShield program that the US Congress may not pass. In addition, the timing or success of Phase 3 clinical trials of SGX942 (dasketide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiotherapy, or other clinical / preclinical trials. Despite the statistically significant results achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T cell lymphoma, there is no guarantee that marketing approval from the FDA or EMA will be successful. In addition, there is no guarantee that RiVax® will be subject to the Biodefense Priority Review Form (PRV) or that previous sales of PRV will indicate the potential selling price of RiVax’s PRV.®.. In addition, there is no guarantee that we will receive or will continue to receive non-diluted Government funding from grants and contracts that we have, or may receive, or will apply to us in the future. These and other risk factors will be explained from time to time upon submission to the Securities and Exchange Commission. This includes, but is not limited to, Soligenix’s reports on forms 10-Q and 10-K. Except as required by law, Soligenix undertakes no obligation to update or revise any forward-looking statement as a result of new information or future events.

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