Ufovax, a vaccine biotechnology company, has extended its property portfolio to incorporate an exclusive global license to a patent covering the planning of an optimized antigen for SARS-CoV-2 (“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 US Patent & Trademark Office (USPTO) on Nov 24, 2020.
Described earlier this year during a submission available on the bioRxiv preprint server, a scientific study of 5 antigen designs was completed along side evaluation of vaccine response in mice. Using the favored S2P mutation of the Spike alone, the optimized spike antigen design (S2GHR2) alone and therefore the S2GHR2 displayed on three different SApNPs during a comparison study, the S2G?HR2-presenting I3-01v9 1c-SApNP vaccine candidate elicited the strongest neutralizing antibody response (7-fold above S2P alone). In another study described within 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. additionally to replacing the double proline mutation (S2P) in heptad repeat 1 (HR1) with a double glycine mutation and substituting several aminoalkanoic 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 a component of the fusion core and causes random spike orientations on the virion surface. Zhu and his team therefore consider this to be a serious explanation for spike metastability. consistent with Zhu, who co-founded Ufovax, this metastability is partly liable 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 application ,” said Ji Li, president & CEO of Ufovax. “This underscores the individuality of our designs and encourages us to continue working tirelessly to possess 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 test could begin as early as 2Q2021.
Zhu added that “The allowance of this patent in such a brief timeframe is sort of gratifying. Our approach is both novel and powerful and that we hope that our COVID-19 vaccine candidate advances even as quickly over the approaching months.”