VBI Vaccines Inc. ( VBIV Quick Quote VBIV - Free Report) announced that it has initiated a phase I/II study to evaluate its monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate — VBI-2902. The vaccine candidate is being developed particularly for immunization against SAR-CoV-2, the virus found in 2019 that started the pandemic.
The study will evaluate the safety, tolerability, and immunogenicity of the candidate, adjuvanted with aluminum phosphate. The phase I portion of the study will evaluate single dose and two-dose regimens of five microgram of the vaccinet now. in healthy adults aged between 18 and 54. This portion will enroll up to 60 participants. Initial data from this portion is expected in the second quarter.
Please note that VBI-2902 demonstrated robust immunogenicity and efficacy compared to placebo in a preclinical hamster challenge study.
The phase II portion will evaluate both dosing regimens with escalating doses of VBI-2902 in a larger patient population in three cohorts — age between 18 and 54, age between 55 and 65, and above 65.
The vaccine candidate, VBI-2902, is being developed as part of the company’s coronavirus vaccine program — VBI-2900 — and supported by funding from the Canada government. The government of Canada awarded VBI Vaccines up to CAD$56 million through its Strategic Innovation Fund to support clinical development through mid-stage studies.
VBI Vaccines’ shares were up 1.9% in after-hours trading following the study initiation news. The company’s shares have skyrocketed 104.8% in the past year compared with the
industry’s growth of 12.7%.
The company is developing another vaccine candidate — VBI-2902 — under the VBI-2900 program. This vaccine candidate is a trivalent pan-coronavirus vaccine, which has the potential to provide protection against SAR-CoV-2 as well as two other coronaviruses — SARS-CoV, and MERS-CoV — found previously in 2003 and 2012, respectively. The candidate is currently being evaluated in another phase I/II study initiated earlier this month. Meanwhile, work is ongoing to further optimize and manufacture the company’s pan-coronavirus vaccine candidate, VBI-2901. The company expects to begin the second phase I/II study later in 2021.
We note that the emergence of COVID-19 virus variants has raised concerns about the efficacy of some medical products/vaccines that have been authorized for emergency use by the FDA. The FDA has thus issued guidelines for vaccine makers to conduct clinical immunogenicity studies, which should compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Although VBI Vaccines’ clinical development is being conducted in Canada, the severity of these variants may likely lead to evaluation of the company’s vaccine candidates against them.
Two approved vaccines —
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech’s ( BNTX Quick Quote BNTX - Free Report) BNT162b2 and Moderna’s ( MRNA Quick Quote MRNA - Free Report) mRNA-1273 — have been tested against these variants in laboratory studies. Both these vaccines have shown similar effectiveness against the UK strain compared to SARS-CoV-2. However, their neutralizing ability was reduced against the South African variant but still remained robust. Pfizer’s BNT162b2 also showed encouraging efficacy against the Brazilian strain. Other approved COVID-19 vaccines include that of AstraZeneca and J&J. Zacks Rank
VBI Vaccine currently carries a Zacks Rank #4 (Sell).
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