VBI Vaccines Announces New Data and Progress of VBI-2900, VBI’s Coronavirus eVLP Program

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– New Phase 1b clinical data for VBI-2905 (monovalent, beta) demonstrated a well-tolerated safety profile and encouraging ability to stimulate and broaden the immune response against the beta variant
– New preclinical data demonstrated antibody titers induced by VBI-2901 (trivalent, pan-coronavirus) that were even higher than VBI-2902 (monovalent, ancestral) against a wide panel of variants, including Omicron and a bat coronavirus that hasn’t yet taken it to humans
– New data continues to strengthen the potential of the eVLP platform against coronaviruses
– The first clinical study of VBI-2901 is expected to start in the summer of 2022

CAMBRIDGE, Mass.–(BUSINESS WIRE)– VBI Vaccines (Nasdaq: VBIV) (VBI), an immunology-focused biopharmaceutical company in the pursuit of potent disease prevention and treatment, today announced updated clinical and preclinical data. day of 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 strain/Wuhan SARS-CoV-2
  • 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)

Jeff Baxter, President and CEO of VBI, said, “These new data continue to strengthen the potential of eVLP candidates against coronaviruses. The magnitude of antibody stimulation against the beta variant in the phase 1b study of VBI-2905 was greater than expected. After one dose, this candidate was able to expand robust immunity to the beta variant, in addition to the ancestral strain (against which participants were previously vaccinated), thereby overcoming the potential for “original antigenic sin.” Additionally, we are excited about the preclinical data we have continued to generate with VBI-2901. We have long believed that to provide long-term protection against known and unknown variants of the coronavirus, we need to stop looking for variants and instead develop vaccines that can provide a broader base of immunity. We believe VBI-2901 has tremendous potential and look forward to initiating our first clinical study of VBI-2901 scheduled for this summer. »

Dr Melanie Saville, Executive Director of Vaccine R&D, CEPI, said: “Over the past two years, we have seen the persistent evolution of SARS-CoV-2. To stay ahead of variants of SARS-CoV-2 and other deadly coronaviruses, the world needs to invest in versatile and broadly protective coronavirus vaccine technologies, like VBI’s advanced eVLP technology. These data represent an important first step in evaluating this technology and towards developing an effective vaccine platform against worrisome variants and other coronavirus threats.

New clinical and preclinical data for all three candidates continued to support the robust potential of the eVLP platform, with candidates that were able to elicit broad immune responses against coronaviruses. These new data demonstrate:

Security:

  • In clinical studies, VBI-2902 and VBI-2905 were well tolerated and no safety signals were observed.
  • VBI-2902 and VBI-2905 were evaluated at a low dose of 5 mcg and both are adjuvanted with aluminum phosphate, a well-known adjuvant with decades of safety data from several FDA-approved vaccines.

Extent 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 against the beta variant by 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 both ancestral variant and delta variant antibody GMTs.
  • Against a panel of coronavirus variants in mice, reactivity was observed with VBI-2902 against all variants, including ancestral strain, Delta, Beta, Omicron, Lambda and RaTG13 (a bat coronavirus distant from circulating human strains).
  • In this same panel, VBI-2901 was able to elicit an even stronger response against all variants tested – as strains became more divergent from the ancestral strain, VBI-2901 elicited a greater difference in GMT versus to VBI-2902, ranging from 2.5-fold higher against the ancestral strain to 9.0-fold higher against bat coronavirus.
  • A validated pseudoparticle neutralization (PNA) assay compared to the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study – this standard measurement would predict an efficacy greater than 90%, with two approved international vaccine tests whose efficacy is estimated at 90% 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 a grant of up to C$56 million, which was recently extended until the end of 2023
  • Contribution of up to 1 million Canadian dollars from a collaboration with the National Research Council of Canada (NRC)

About VBI’s Coronavirus Vaccination Program: VBI-2900
VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the spike proteins SARS-CoV-2, SARS-CoV and MERS-CoV , (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 prefusion form modified beta variant spike protein (also known as B.1.351). The vaccine program was developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through its Strategic Innovation Fund. .

About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is an immunology-focused biopharmaceutical company in the pursuit of potent disease prevention and treatment. Through its innovative Virus-Like Particle (“VLP”) approach, including proprietary enveloped VLP (“eVLP”) platform technology, VBI is developing candidate vaccines that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. system. VBI is committed to targeting and defeating important infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers, including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

For more information, visit www.vbivaccines.com.

Caution regarding forward-looking information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian laws. securities (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. These forward-looking statements are based on management’s beliefs as well as assumptions made by management and information currently available to it. Actual results could differ materially from those contemplated by the forward-looking statements due to certain factors, including, but not limited to, the impact of general economic, industrial or political conditions in the United States or internationally. ; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are effective or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of candidate pipelines and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to commercialize potential products; the ability to obtain future financing for development products and working capital and to obtain such financing on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaboration with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to obtain and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties relating to the Company, is set forth in the Company’s filings with the SEC and Canadian securities regulators, including its Annual Report on Form 10. -K filed with the SEC on March 7, 2022, and filed with Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10- Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on these forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no obligation or duty to update or revise any forward-looking statements for any reason, except as required by law.

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