Ufovax, LLC, (Ufovax), a vaccine biotechnology company based on the Single-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), has extended its intellectual property portfolio to include an exclusive global license to a patent covering the design of an optimized antigen for SARS-CoV-2 (aka “COVID-19”). The patent, entitled Stabilized Coronavirus Spike (S) Protein Immunogens and Related Vaccines, was filed by Scripps Research on June 29th of this year and was allowed by the U.S. Patent & Trademark Office (USPTO) on Nov 24, 2020.
Described earlier this year in a submission available on the bioRxiv preprint server, a systematic study of five antigen designs was completed along with evaluation of vaccine response in mice. Using the popular S2P mutation of the Spike alone, the optimized spike antigen design (S2GΔHR2) alone and the S2GΔHR2 displayed on three different SApNPs in a comparison study, the S2GΔHR2-presenting I3-01v9 1c-SApNP vaccine candidate elicited the strongest neutralizing antibody response (7-fold higher than S2P alone). In another study described in the same submission, the SApNP presenting this optimized spike antigen was also shown to elicit a positive TH1 profile in mice.
The now-patented optimized spike has several distinguishing features. In addition to replacing the double proline mutation (S2P) in heptad repeat 1 (HR1) with a double glycine mutation and substituting several amino acid residues of the S1/S2 cleavage site, this spike is purposefully missing the highly flexible heptad repeat 2 (HR2) stalk. As reported in several independent publications, the HR2 stalk is part of the fusion core and causes random spike orientations on the virion surface. Zhu and his team therefore consider this to be a major cause of spike metastability. According to Zhu, who co-founded Ufovax, this metastability is partly responsible for masking the COVID-19 spike from immune recognition and allowing very efficient human infection.
“We are quite excited with the rapid review and allowance of this patent application,” said Ji Li, President & CEO of Ufovax. “This underscores the uniqueness of our designs and encourages us to continue working tirelessly to have our next-generation vaccine candidate advanced into the clinic as soon as possible.” With GMP-production well underway, IND-enabling studies are planned for early 2021. With the expectation of expedited review, a Phase I/II clinical trial could begin as early as 2Q2021.
Zhu added that “The allowance of this patent in such a short timeframe is quite gratifying. Our approach is both novel and strong and we hope that our COVID-19 vaccine candidate advances just as quickly over the coming months.”
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.