PRINCETON, N.J.—Soligenix Inc. reported today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a Direct to Phase 2 Small Business Innovation Research (SBIR) grant of around $1.5 million.
The grant is intended to support the manufacture, formulation, and characterization of COVID-19 and ebola virus vaccine candidates, in conjunction with the CoVaccine HT adjuvant. The award will also support immune characterization of this emulsified adjuvant with unique potency and compatibility with lyophilization strategies, in order to enable the thermostabilization of subunit vaccines.
The award will enable detailed immunogenicity evaluation of CoVaccine in the presence of either the SARS-CoV-2 Spike protein antigen, or the Zaire ebolavirus glycoprotein antigen, in both mice and non-human primates. It will significantly enhance both vaccine programs, and enable the re-initiation of key CoVaccine manufacturing processes.
“We are appreciative of the continued support provided by NIAID for our thermostabilization program,” stated Dr. Christopher J. Schaber, president and CEO of Soligenix. “This SBIR grant award will further advance our studies with the CoVaccine adjuvant, as well as our CiVax and filovirus vaccine programs. We remain dedicated to progressing our Public Health Solutions business segment and look forward to accelerating our CiVax program in particular with this funding.”
CiVax is Soligenix’s heat stable subunit vaccine candidate for the prevention of COVID-19. Ongoing collaborations with Dr. Axel Lehrer, associate professor of Vaccinology in the Department of Tropical Medicine, Medical Microbiology, and Pharmacology in the John A. Burns School of Medicine at the University of Hawai?i at Mānoa, have demonstrated the feasibility of developing a highly immunogenic COVID-19 vaccine.
Soligenix believes that the essential attributes of a vaccine capable of controlling the ongoing pandemic include the ability to rapidly stimulate a Th1/Th2 balanced antibody response, raising significant virus neutralizing antibodies, and the ability to induce potent cell-mediated immunity. Previous work with the CoVaccine adjuvant (which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) has indicated that CoVaccine possesses these characteristics.
And unlike vaccine candidates that have logistical challenges due to cold chain requirements, the underlying technology platform has demonstrated the ability to produce single vial vaccines that are stable up to temperatures as high as +40 degrees Celsius. The resulting vaccine should be broadly applicable, according to the company: including individuals often excluded from common viral vector vaccine approaches like children, the elderly, and those who are immunocompromised.