• VBI-2901 and VBI-2902 selected as trivalent and monovalent coronavirus vaccine candidates, respectively, for an adaptive Phase 1/2 clinical study expected to begin around year-end 2020, subject to regulatory approvals
  • After one dose, compared to high-titer convalescent sera, preclinical data demonstrated 10x higher antibody binding geometric mean titer (GMT) and 4x higher neutralizing antibody GMT, with neutralizing antibody GMT increasing to 64x after a second dose
  • GMP clinical manufacturing expected to begin in September 2020 at Therapure Biomanufacturing – potential to leverage capacity to support large-scale manufacturing
  • VBI to host conference call and webcast today, Wednesday, August 26 at 8:30 AM ET

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced data from three preclinical mouse studies conducted to enable selection of optimized clinical candidates for the company’s coronavirus program, VBI-2900. As a result of these studies, VBI has selected two vaccine candidates, with the potential to be one-dose vaccines, to take into an adaptive Phase 1/2 human clinical study, expected to begin around year-end 2020, subject to regulatory approval: (1) VBI-2901, a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins; and (2) VBI-2902, a monovalent vaccine candidate expressing the SARS-CoV-2 (COVID-19) spike protein.

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The objectives of the preclinical studies, which evaluated antibody binding titers and neutralizing antibody titers across a number of vaccine constructs, were to assess the impact of VBI’s proprietary enveloped virus-like particle (eVLP) platform technology vs. recombinant vaccine candidates, differences in the conformation of the spike protein, and a variety of adjuvants. The data demonstrated:

  • Neutralizing Antibody (nAb) Activity: After a single dose, VBI’s eVLPs expressing a stabilized pre-fusion form of the COVID-19 spike protein elicited a nAb GMT that was 4x higher than the GMT of high-titer convalescent sera, which increased to 64x higher after a second dose
  • Antibody Binding (Ab) Activity: The same eVLPs also induced, after one dose, an Ab binding GMT that was 10x higher than both the GMT of high-titer convalescent sera and the GMT induced with a stabilized pre-fusion recombinant spike protein
  • Impact of Adjuvants: A variety of adjuvants tested further improved the induction of nAb titers approximately 5-fold, and promoted strong Th1-type antibody and T cell responses
  • Additional Benefit of Trivalent Construct: The trivalent eVLP vaccine construct induced Ab binding titers across COVID-19, SARS, and MERS spike proteins in addition to broadening reactivity to a seasonal human coronavirus not expressed in the vaccine

“We are excited to announce these impressive pre-clinical data, which we believe clearly support the advancement of the two vaccine candidates, VBI-2901 and VBI-2902, into human clinical studies around the end of the year,” said Jeff Baxter, VBI’s President and CEO. “An effective solution to the ongoing COVID-19 pandemic will require a vaccine that is capable of providing robust protection, quickly. Based on the data seen to-date, we believe the VBI-2900 program has the potential to be administered as a one-dose vaccine regimen at human doses ranging from 2-5mcg, and, further, VBI-2901 may offer increased breadth of reactivity across a broader range of coronaviruses. We are very encouraged by these results and remain deeply committed to addressing this devastating public health crisis.”

As part of these studies, convalescent sera from 20 individuals who had contracted and recovered from COVID-19 were collected for comparison – this sera was further grouped according to those who mounted a high-titer, robust response to the infection and those with a low-titer, weaker response. The neutralizing activity in these studies were quanitifed using a plaque reduction neutralization test with the most stringent 90% inhibition threshold (PRNT90), which is considered the gold standard for measuring antibodies that can neutralize a virus.

In August, VBI also entered into an agreement with Therapure Biomanufacturing, an integrated Contract Development and Manufacturing Organization (CDMO), for development and manufacturing services in preparation for production of its coronavirus vaccine candidates. The collaboration with Therapure is expected to enable the initiation of clinical studies by the end of 2020. As part of the agreement, Therapure will manufacture bulk vaccine for use through Phase 2 clinical studies.

Conference Call and Webcast Details

VBI Vaccines will host a conference call and webcast with accompanying slides on Wednesday, August 26, 2020 at 8:30 AM ET. The live webcast and slide presentation can be accessed via the Events/Presentations page in the Investors section of the company’s website, or by clicking this link: https://lifescipartners.zoom.us/webinar/register/2815964896473/WN_u0Jd4Y-PRBmxfymC7VqItw.

A replay of the webcast will be archived on the company’s website for 30 days following the live conference call.