Small Biz Grant Funds Heat-Stable Multi-Virus Vaccine

Scanning electron microscope image showing SARS-CoV-2 viruses, in yellow. (NIAID, NIH)

28 Dec. 2020. A biotechnology company is receiving a federal grant for a vaccine in freeze-dried form to prevent infections from Covid-19 and Ebola viruses. National Institute of Allergy and Infectious Diseases, or NIAID, in National Institutes of Health, is awarding some $1.5 million to Soligenix Inc. in Princeton, New Jersey for the two-year project.

Soligenix is a developer mainly of therapies for rare diseases, but the company also devotes resources for its public health programs, including infectious disease and bio-defense countermeasures. One of its public health programs is ThermoVax, a process for formulating vaccines and adjuvants in freeze-dried form. Once in this form, vaccines can be stored and transported in ambient temperatures, up to 40 C/104 F. As a result, vaccines made with ThermoVax do need refrigeration or freezing throughout the supply chain, as needed by other vaccines like those already authorized by Food and Drug Administration to prevent Covid-19 infections.

The NIAID grant funds development by Soligenix of an adjuvant, a vaccine additive that boosts its immune response, amenable to freeze-drying. The adjuvant is expected to generate immune responses from both antibodies and T-cells to antigens, in vaccines to prevent SARS-CoV-2, but also other infectious diseases that infect cells with glycoproteins on their spikes. The work includes formulations for Zaire and Sudan strains of Ebola virus, and Marburg virus, as well as SARS-CoV-2. The goal is to advance the technology to a single vaccine protecting against all three filoviruses, with single-strand RNA genomes.

In addition, the researchers will test the adjuvant with Soligenix’s Covid-19 vaccine called CiVax for immune response to SARS-CoV-2 and Ebola viruses. CiVax includes an antigen to generate an immune response and an adjuvant, formulated in heat-stable form. In October, researchers led by Axel Lehrer, a researcher in tropical medicines at University of Hawaii in Honolulu, published findings showing CiVax, then known as CoVaccine HT, and adjuvants in lab mice generated both neutralizing immunoglobulin G antibodies and T-cell responses from a single dose.

The grant is awarded under NIH’s Small Business Innovation Research, or SBIR, program that sets aside a portion of its overall research funding for small U.S.-based companies with science-based products. NIH says it invests more than $1 billion in SBIR and related awards. Most SBIR grants are awarded to two parts, first to show feasibility, then to develop a prototype. This award funds work in both stages, ending in a prototype.

“This SBIR grant award,” says Christopher Schaber, Soligenix’s president and CEO in a company statement, “will further advance our studies with the CoVaccine adjuvant, as well as our CiVax and filovirus vaccine programs.”

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