VBI Vaccines Inc. announced updated clinical and preclinical data from its coronavirus program, VBI-2900. VBI-2900 consists of three candidates derived from the company's proprietary enveloped virus-like particle (eVLP) technology platform, including: VBI-2902: A monovalent candidate directed against the ancestral/Wuhan SARS-CoV-2 strain. VBI-2905: A monovalent candidate directed against the Beta SARS-CoV-2 variant.

VBI-2901: A trivalent, pan-coronavirus candidate targeting SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS). In clinical studies, VBI-2902 and VBI-2905 were well-tolerated with no safety signals observed. VBI-2902 and VBI-2905 were evaluated at a low dose of 5µg and both are adjuvanted with aluminum phosphate, a well-known adjuvant with decades of safety data from multiple FDA-approved vaccines.

Breadth of Immunogenicity: In the Phase 1b study (n=53), a single-dose booster of VBI-2905 increased the geometric mean titer (GMT) of neutralizing antibodies directed against the Beta variant 3.8-fold, at day 28, in participants who had previously received two-doses of an mRNA vaccine (ancestral strain) – approximately 2-fold increases were also seen at day 28 in antibody GMTs against both the ancestral and delta variant. Against a panel of coronavirus variants in mice, reactivity was seen with VBI-2902 against all variants including the ancestral strain, Delta, Beta, Omicron, Lambda, and RaTG13 (a bat coronavirus that is distant to circulating human strains). In this same panel, VBI-2901 was able to elicit an even stronger response against all variants tested – as the strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT from VBI-2902, ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against the bat coronavirus.

A validated pseudoparticle neutralization assay (PNA) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study – this international standard measure would predict a greater than 90% efficacy, with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021). The VBI-2900 program is supported by: A partnership with CEPI, with a contribution of up to $33 million. A partnership with the Government of Canada through its Strategic Innovation Fund, with an award of up to CAD 56 million, which was recently extended through the end of 2023 Contribution of up to CAD 1 million from a collaboration with the National Research Council of Canada (NRC).

VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19 vaccine expressing a modified prefusion form of the SARS-CoV-2 spike protein, and (3) VBI-2905, a monovalent COVID-19 vaccine expressing a modified prefusion form of the spike protein from the Beta variant (also known as B.1.351). The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund.