{"id":405715,"date":"2020-12-28T07:03:20","date_gmt":"2020-12-28T12:03:20","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=405715"},"modified":"2020-12-28T07:03:20","modified_gmt":"2020-12-28T12:03:20","slug":"soligenix-announces-1-5-million-nih-small-business-innovation-research-award-advancing-covid-19-vaccine-development","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/soligenix-announces-1-5-million-nih-small-business-innovation-research-award-advancing-covid-19-vaccine-development\/","title":{"rendered":"Soligenix Announces $1.5 Million NIH Small Business Innovation Research Award Advancing COVID-19 Vaccine Development"},"content":{"rendered":"
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Supports CoVaccine HT\u2122 platform development<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n PRINCETON, N.J.<\/span>, Dec. 28, 2020<\/span> \/PRNewswire\/ —\u00a0Soligenix, 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 that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded Soligenix a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $1.5 million<\/span> to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 (Coronavirus Disease 2019) and EVD (Ebola Virus Disease) vaccine candidates in conjunction with the CoVaccine HT\u2122 (CoVaccine) adjuvant.\u00a0 This award also will support immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.<\/p>\n

CiVax\u2122 is the Company’s heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.\u00a0 Ongoing collaborations with Axel Lehrer<\/span>, PhD, Associate Professor (Vaccinology) in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School<\/span> of Medicine (JABSOM), University of Hawai\u02bbi at M\u0101noa (UHM) have demonstrated the feasibility of developing a highly immunogenic vaccine for COVID-19<\/a>.\u00a0 With significant research dedicated worldwide to the generation of COVID-19 vaccines, it is noteworthy that the essential attributes of a vaccine successful in controlling the ongoing pandemic are believed to include the ability to rapidly stimulate a Th1\/Th2 balanced antibody response, raising significant virus neutralizing antibodies, as well as induce potent cell-mediated immunity.\u00a0 Previous work with the CoVaccine adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine has these critical characteristics.\u00a0 In addition, unlike other vaccine candidates that have logistical challenges due to cold chain requirements (in some cases requiring maintenance of temperatures less than -70 degrees Celsius), the underlying technology platform has demonstrated the ability to produce single vial vaccines which are stable up to temperatures at least as high as +40 degrees Celsius.<\/p>\n

The awarded grant enables detailed immunogenicity evaluation of CoVaccine in the presence of either the SARS-CoV-2 Spike protein antigen or the Zaire<\/span> ebolavirus glycoprotein antigen in both mice and non-human primates, and will significantly enhance both vaccine programs.\u00a0 It also will enable re-initiation of key CoVaccine manufacturing processes. <\/p>\n

Many programs are focused on the development of vaccines for COVID-19 and two vaccines have recently received Emergency Use Approval by the FDA. \u00a0However, the worldwide extent of the problem suggests that a complete solution to the pandemic will require parallel approaches.\u00a0 Moreover, there is the potential need for annual vaccinations. \u00a0The total number of vaccine doses required to control the ongoing pandemic also suggests that multiple vaccines, based on different manufacturing platforms, will be necessary to efficiently vaccinate the worldwide population.\u00a0 Subunit vaccines are considered the gold standard for vaccine safety, but are relatively under-represented in fast-tracked COVID-19 vaccine candidates to date.\u00a0 Unlike virally vectored vaccines, there is no limit to the number of times the adjuvant and antigen can be used and the typical safety profile of a subunit vaccine results in a vaccine that is suitable for immune compromised or elderly populations as well.\u00a0 Further, while RNA vaccines are rapid to manufacture, the requirements for cold chain distribution remain a real constraint.<\/p>\n

“We are appreciative of the continued support provided by NIAID for our thermostabilization program,” stated Christopher J. Schaber<\/span>, PhD, President and Chief Executive Officer of Soligenix. “This SBIR grant award will further advance our studies with the CoVaccine adjuvant, as well as our CiVax\u2122 and filovirus vaccine programs.\u00a0 We remain dedicated to progressing our Public Health Solutions business segment and look forward to accelerating our CiVax\u2122 program in particular with this funding.” <\/p>\n

NIAID support is being provided through SBIR grant number 1 R44 AI157593-01.<\/p>\n

\n About CiVax\u2122 <\/b>\n <\/p>\n

CiVax\u2122 is the Company’s heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2.\u00a0 Under the Company’s Public Health Solutions business segment, ongoing collaborations with Axel Lehrer<\/span>, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UHM have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including hemorrhagic disease caused by Zaire<\/span> ebolavirus<\/i>, Sudan<\/span> ebolavirus<\/i> as well as Marburg marburgvirus<\/i>, with both monovalent and bivalent vaccine combinations.\u00a0 Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). \u00a0In March 2020<\/span><\/a>, Soligenix and its collaborators expanded the technology platform to assess compatibility with vaccine candidates targeting SARS-CoV-2, the cause of COVID-19.<\/p>\n

The vaccine platform includes three essential components:<\/p>\n

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  1. a protein antigen, specifically a viral surface glycoprotein, which mediates entry and fusion of the virus with host cells and is manufactured with a proprietary insect cell expression system coupled with protein-specific affinity purification; <\/li>\n
  2. an adjuvant which has been shown to enhance both cell mediated and humoral immunity; and <\/li>\n
  3. a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping.<\/li>\n<\/ol>\n

    The resulting vaccine is broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised.\u00a0 The protection of elderly and immunocompromised populations are particularly important in the context of COVID-19. The ability to provide a thermostabilized, single vial vaccine, is particularly important in the context of rapid and broad vaccine distribution. <\/p>\n

    These same components are now being applied to coronavirus vaccine, using the well-defined surface glycoprotein, known as the Spike protein, as the antigen. Nonclinical work in mice with a prototype vaccine recently have been published<\/a>, demonstrating the ability of the CoVaccine adjuvant in combination with a prototype antigen, to: <\/p>\n