WILMINGTON, Del.–(BUSINESS WIRE)–Ufovax, LLC, (Ufovax), a vaccine biotechnology company based on the patented One-component Self-Assembling protein NanoParticle® (1c-SApNP®) vaccine design and manufacturing platform invented by Associate Professor Jiang Zhu, PhD, of Scripps Research (La Jolla, CA), announced the advancement toward Phase I clinical trials of its next-generation SARS-CoV-2 (aka “COVID-19”) vaccine candidate. Ufovax holds an exclusive global license to the Scripps Intellectual Property covering the platform and several vaccines, including COVID-19.
In a publication submitted Monday, September 14 (now available on the bioRxiv preprint server), the authors present a systematic study on rational vaccine design and evaluation of vaccine response in mice. In particular, Zhu and his team propose a new spike antigen design (S2GΔHR2) and displayed it on several SApNPs as COVID-19 vaccine candidates. This spike is missing the highly flexible heptad repeat 2 (HR2) stalk which, as recently reported in several independent publications, is considered a major cause of spike metastability. This metastability is the mechanism responsible for masking the COVID-19 spike from immune recognition and allowing very efficient human infection.
“We are very impressed with the outstanding performance of our COVID-19 nanoparticle vaccine candidate (S2GΔHR2-presenting I3-01v9 1c-SApNP) in pre-clinical immunogenicity tests,” said Ji Li, President & CEO of Ufovax. “These studies were conducted in direct comparison to our S2GΔHR2 spike alone (not carried on a nanoparticle) as well as the S2P spike alone, which is used in many other COVID-19 vaccine designs, and we have seen consistent 8- to 10-fold increases in neutralizing antibody (NAb) titers in mice using this novel COVID-19 vaccine design.” This construct also induced critically needed cellular (T-cell) immunity, and thereby is a next-generation vaccine candidate to battle the COVID-19 pandemic. “We are now advancing our leading vaccine candidate and expect a Phase I clinical trial in early 2021,” Li continued.
Zhu, who co-founded Ufovax, added, “These results are consistent with our previous HIV, HCV, and Ebola vaccine studies demonstrating that such prefusion-optimized spike antigens displayed on protein nanoparticles elicit NAb responses more effectively than antigen-only vaccine approaches. This is also consistent with the well-established theory that the human immune system recognizes virus-like particles (VLPs) and generates corresponding protective immune responses. In practice, we have seen similar performance from the Merck HPV Gardasil® vaccine – which is essentially a protein nanoparticle vaccine.”
Over the past two years Zhu has been a co-investigator on two NIH-supported projects focusing on coronavirus (SARS-CoV-1 and MERS-CoV) vaccine development. Since the outbreak, Zhu and his team, sponsored by Ufovax, have worked tirelessly to create a 1c-SApNP vaccine against SARS-CoV-2, using the novel multilayered protein nanoparticle design described in another recent publication.
Ufovax is a privately held biotechnology company currently focused on the development of protein nanoparticle vaccines for infectious diseases and has a pipeline of eight additional vaccines in pre-clinical development. For more information visit www.ufovax.com.
Colette Saccomanno, SVP of Corporate Affairs