Tuesday, December 29, 2020
Soligenix, Inc., 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 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™ (CoVaccine) adjuvant. 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.
CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. Ongoing collaborations with Axel Lehrer, PhD, Associate Professor (Vaccinology) in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa (UHM) have demonstrated the feasibility of developing a highly immunogenic vaccine for COVID-19. 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. 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. 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.
The awarded grant enables 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, and will significantly enhance both vaccine programs. It also will enable re-initiation of key CoVaccine manufacturing processes.
Many programs are focused on the development of vaccines for COVID-19 and two vaccines have recently received Emergency Use Approval by the FDA. However, the worldwide extent of the problem suggests that a complete solution to the pandemic will require parallel approaches. Moreover, there is the potential need for annual vaccinations. The 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. Subunit vaccines are considered the gold standard for vaccine safety, but are relatively under-represented in fast-tracked COVID-19 vaccine candidates to date. 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. Further, while RNA vaccines are rapid to manufacture, the requirements for cold chain distribution remain a real constraint.
"We are appreciative of the continued support provided by NIAID for our thermostabilization program," stated Christopher J. Schaber, 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™ 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."
