Soligenix Inc. (NasdaqGS: SNGX), through its Public Health Solutions business segment, announced on Monday that the company is expanding its ongoing collaboration with the University of Hawai’i at Manoa to assess potential coronavirus vaccines, including COVID-19. More specifically, the study is evaluating the application of the company’s heat-stabilization technology that has the potential to substantially alleviate the strains of cold-storage and distribution challenges associated with vaccines that need to progress quickly through supply channels.
The heat-stabilization technology has demonstrated the feasibility of developing heat-stable subunit filovirus vaccines, including the Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations.
Investors sent shares higher by more than 17% at the market open. Zacks Small-Cap Research updated its coverage on Soligenix as well and raised its valuation of the stock to $12.00 per share. The increase is based on its adjusted DCF model that takes into account potential future revenues from SGX301 and SGX942.
Vaccine Heat-Stabilization Can Be A Substantial Franchise
According to Soligenix, 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). Soligenix and its collaborators are expanding the technology platform to assess compatibility with coronaviruses, including SARS-CoV-2, the cause of COVID-19.
The funding for the expanded program is expected to be financed by non-dilutive funding sources, such as the US government.
Most certainly, heat-stabilization technology can be a lucrative franchise. It would enable the distribution of vital vaccine products to get distributed almost seamlessly through distribution channels that are not favorable to cold-storage. The technology has proven an ability to maintain therapeutic potency at holding temperatures as high as 104 degrees Fahrenheit.
Soligenix highlighted three essential components of the heat-stabilization platform:
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;
2) an adjuvant which has been shown to enhance both cell-mediated and humoral immunity; and
3) a formulation which enables thermostabilization of the resulting mixture, avoiding the need for cold chain storage and shipping
Combined, the resulting vaccine is broadly applicable, including individuals often excluded from common viral vector vaccine approaches such as children, the elderly, and the immunocompromised. These same components can now be applied to coronavirus vaccine, using well-defined surface glycoprotein(s) from one or more coronaviruses, which will include critical antigens expected to be protective for COVID-19. The protection of elderly and immunocompromised populations is particularly important in the context of COVID-19.
Data Supports Heat-Stabilization Compatibility For Coronavirus
The platform has already produced encouraging results. Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM, stated, “Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing, but also the potential for a broadly applicable and easily distributed vaccine. We are delighted with our successes on development of filovirus and flavivirus vaccines using our platform and look forward to accelerated studies with the coronaviruses.
Also, JABSOM Dean Jerris R. Hedges, MD, MS, MMM, said, “It is rewarding to see ongoing work by JABSOM investigators and collaborators expanding on successful research on filovirus vaccines (protecting against viruses such as Ebola and Marburg virus) that may help us make unique life-saving contributions during this difficult time in healthcare. The prospect of a science lab in Hawaiʻi helping develop a vaccine amid the COVID-19 pandemic is a testament to the importance of local research in Hawaiʻi.”
Soligenix Well-Positioned To Contribute To COVID-19 Platform
Through its Public Health Solutions business segment, Soligenix is well-positioned to create a subunit vaccine with enhanced stability at elevated temperatures. Undoubtedly, the result can prevent the costs and logistical burdens associated with cold chain storage and distribution, and has the potential to provide a distinct advantage over other vaccines currently in development and simplifies worldwide delivery.
Because of the pace of advancement of the filovirus vaccine platform, Soligenix added in its release that the program is optimally poised to look at other viruses and infections, including COVID-19.
The news on Monday followed the company’s release last Thursday that reported positive statistically significant topline data for its pivotal Phase 3 SGX301 FLASH trial. That Phase 3 study is evaluating SGX301 to treat patients with CTCL. A report of those findings can be found here.
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