VBI Vaccines Inc. VBIV announced that it has selected two pre-clinical candidates as coronavirus vaccine for clinical-stage development. The selection was based on encouraging data from three pre-clinical mouse studies, which evaluated one dose of the candidates. These studies were conducted particularly to enable selection of optimized clinical candidates for the company’s coronavirus program, VBI-2900.
The company selected one trivalent vaccine — VBI-2901 — and a monovalent vaccine — VBI-2902 — to evaluate in a phase I/II study, with the potential to be one-dose vaccines. The study is expected to start toward the end of this year, subject to regulatory approval. VBI-2901 is a pan-coronavirus vaccine candidate, which expresses the SARS-CoV-2 (COVID-19), SARS-CoV (“SARS”), and MERS-CoV (“MERS”) spike proteins. VBI-2902 only expresses the SARS-CoV-2 spike protein.
Shares of VBI Vaccines’ surged more than 32% on Aug 27, following the announcement. The company’s shares have skyrocketed 582.8% in the year so far compared with the industry’s growth of 14.1%.
Please note that the vaccine candidates were developed using VBI Vaccines’ proprietary enveloped virus-like particle (eVLP) platform technology. Data from pre-clinical studies showed that following one dose of vaccine candidates, patients achieved neutralizing antibody binding (nAb) geometric mean titer (“GMT”) four times compared to the GMT of high-titer convalescent sera, individuals who had contracted and recovered from COVID-19 with robust response, naturally. Patients receiving second dose achieved 64 times nAb GMT compared to high-titer convalescent sera.
A single dose of vaccine candidates also induced 10 times antibody binding (Ab) GMT compared to high-titer convalescent sera. Moreover, the trivalent vaccine candidate induced Ab binding titers across COVID-19, SARS, and MERS spike proteins. The candidate was also observed to have reactivity to a seasonal human coronavirus not expressed in the vaccine.
Based on the data from the three pre-clinical studies, the company believes that a single dose of its vaccine candidates may offer protection to individuals against COVID-19, with the trivalent vaccine candidate providing protection against all types of known coronaviruses.
Earlier this month, VBI Vaccines signed an agreement with the Contract Development and Manufacturing Organization, Therapure Biomanufacturing, for development and manufacturing of the vaccine candidates to support clinical studies.
Meanwhile, we note that three coronavirus vaccine candidates from other players have already reached final-stage of development. These are Moderna’s MRNA mRNA-1273, Pfizer PFE/BioNTech’s BNT162b program, and Oxford University/AstraZeneca’s AZN AZD1222. These companies are planning to launch their coronavirus vaccine candidate by the end of this year, subject regulatory approvals. The companies have also signed several supply agreements with different countries for billions of doses of their candidates. However, all these candidates are being developed with a two-dose regimen. The potential of VBI Vaccine’s candidates for a single-dose regimen may prove beneficial following a commercial launch.
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VBI Vaccine currently carries a Zacks Rank #4 (Sell).
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