VBI Vaccines’ Pan-Coronavirus Vaccine Candidate, VBI-2901, Induced Broad and Durable Protective Titers Against Variants of Concern

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 1 clinical study of its multivalent pan-coronavirus vaccine candidate, VBI-2901, which expresses the ancestral COVID-19, SARS, and MERS spike antigens. The Phase 1 clinical study enrolled 101 adults, aged 18-64 years who had received either two or three doses of a messenger RNA (mRNA) COVID-19 vaccine licensed by Health Canada, and assessed both one and two dose booster regimens of VBI-2901. Based on interim data, however, peak responses were achieved with only a single 10µg dose of VBI-2901.

“As we’ve previously said, we endeavor to develop a vaccine with meaningful differentiation to those COVID-19 vaccines already approved – we believe these initial data are evidence of just that, demonstrating an ability to safely broaden durable, protective levels of immune responses and significantly boost neutralizing responses in participants with low baseline antibody titers,” said Jeff Baxter, VBI’s President and CEO. “With sufficient funding available under our current partnerships, subject to discussions with our partners and with regulatory bodies, we look forward to advancing this program and being a part of the innovative next-generation of protection against coronaviruses.”

Breadth of Immune Response

• All participants saw boosting and/or high neutralizing responses against a panel of COVID-19 variants, including Wuhan, Delta, Beta, Omicron BA.5, as well as multiple animal coronaviruses including bat and pangolin variants
• Participants with low baseline neutralization titers (geometric mean titer (GMT): 148 IU50/mL), who are at the highest risk of infection, saw the greatest vaccine-induced boosting effects across all variants tested at Day 28, after one dose, with increases of: 8.5x against Wuhan, 9.1x against Delta, 14.2x against Beta, and 5.8x against Omicron BA.5

Durability of Immune Response

• All participants who received one dose had enhanced persistence of neutralizing responses, with only about 25% reduction in GMT against Wuhan after 5 months vs. peak responses
• Similar enhanced durability trends were observed against all tested variants
• By comparison, a recently published study [Gilboa et al., 2022] evaluating immune responses after a third dose of a licensed mRNA vaccine in nearly 4,000 healthcare workers in Israel demonstrated an approximate 77% decline in GMT against Wuhan after 5 months vs. peak responses¹
  • In the same study [Gilboa et al., 2022], durability trends against other variants, including Omicron, were seen to wane even more aggressively, with 4-fold to 10-fold lower neutralization titers within 4 months of the third dose

About the Phase 1 Study