Data Rich Year Ahead

Virtual & In-person Roadshows / Conferences

Channelchek Premium. Access more at no cost. 

The site "channelcheck" is opened on the phone

Join the Channelchek Investor Community. Your name, email, zip, and investor type is all it takes to open the door to research reports, favorites tracking, and virtual and in-person roadshows / conferences. Even exclusive investment opps.

Take it to the next level. It doesn’t cost a penny.

Click “Log In” to agree to Channelchek.com <a href="#">Terms of Use</a> and acknowledge that Channelchek.com <a href="#">Privacy Policy</a> applies to you.

Welcome to the Channelchek Investor Community

Informed investors make more money. And it’s all about timing. Get it when it happens.

Inbox Intel from Channelchek.

Healthcare

Biotechnology

VBI Vaccines Inc.

Executive Summary&nbsp;
VBI Vaccines Inc. (Nasdaq:VBIB) is a commercial stage biopharmaceutical company developing next generation vaccines &nbsp;for infectious disease and cancer. The company leverages two complementary technology platforms; enveloped Virus-Like Particles (eVLP) vaccine and thermostable Lipid Particle Vaccines (LPV) platform to develop vaccines for hepatitis, cytomegalovirus (CMV) and glioblastoma multiforme (GBM). 
Figure 1. VBI Vaccines Pipeline
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/VBI1.jpg" style="width: 560px;height: 289px" />
Source: Company Presentation October 2018
 VBI&#8217;s lead compound Sci-B-Vac is a third-generation hepatitis B (Hep-B) vaccine which contains three naturally occurring Hep-B virus surface antigens: &#8220;S&#8221;, &#8220;preS1&#8221; and &#8220;preS2&#8221;. Sci-B-Vac is already approved in Israel and nine other countries outside of US and Europe. The company is conducting two pivotal Phase 3 studies (PROTECT and CONSTANT) to support a new drug application (NDA) filing and approval in the U.S PROTECT, a double-blind, randomized controlled trial, is designed to establish the non-inferiority of Sci-B-Vac seroprotection (compared to Engerix-B in adults ? 45 years old). Seroprotection is defined as an antibody response capable of preventing infection, commonly used in vaccination response. Interim data analysis showed higher seroprotection rates in adults &gt;45 years old (96%) compared to standard of care GSK&#8217;s Engerix-B (78%) (Figure 2). The target market for Sci-B-Vac is patients who do not respond standard of care or have low seroconversion (the period of time which a specific antibody develops and becomes detectable in the blood). Targeted patients also include the elderly and those with chronic diseases (diabetes, liver disease) who are at high risk of Hepatitis B infection. The second Phase 3 CONSTANT trial is a double-blind, randomized controlled study, being conducted to measure a lot-to-lot consistency, manufacturing equivalence, and consistency in immunogenicity of three independent consecutive lots of the Sci-B-Vac following the third vaccination. VBI announced completion of PROTECT trial in October 16, 2018. VBI stated top-line data from PROTECT is expected to readout in mid-2019, CONSTANT data is expected to readout in 2H/2019.
Figure 2. Sci-B-Vac Showed Superior Seroprotection in Older Adults (age over 45)
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/VBI2.jpg" style="width: 561px;height: 249px" />
Source: Company Presentation 2018
Other products that are currently in the clinic include VBI-1501A, a prophylactic vaccine against cytomegalovirus (CMV), and VBI-1901A against recurrent glioblastoma. Both products utilize the eVLP technology platform allowing the expression of envelope glycoproteins of related viruses. Virus like particles (VLPs) are nanoparticles utilized in vaccine development by engineering to carry viral antigens. The composition of VLPs mimic viruses, however don&#8217;t carry viral genome. VBI&#8217;s eVLP Platform technology allows for the development of enveloped (&#8220;e&#8221;) VLP vaccines that closely mimic the target virus to elicit a potent immune response.&nbsp;They represent the same size and structure as enveloped viruses; present antigens in their natural state for an improved immune response.
Both products were generated using VBI&#8217;s proprietary eVLP platform technology, which enables the expression of viral envelope glycoproteins on the surface of virus like particles (VLPs). VLPs have a similar structure when compared to a natural virus. Unlike viruses, VLPs do not contain a viral genome. VLPs are designed to present viral antigens in their natural state, which elicits a more potent immune response. 
 VBI-1501A consists of the CMV glycoprotein B (&#8220;gB&#8221;) antigen plus alum, an adjuvant used in various FDA-approved products. It is currently in a Phase 1 clinical study. Interim data analysis from this study showed that immunization with the highest dose of the vaccine induced seroconversion in 100% of subjects after two vaccinations, while demonstrating an increase in all gB antibody binding titers across all dose levels as shown in Figure 3. Neutralizing antibodies against epithelial cell infection were detected resulting in 31% and 17% seroconversion rate for subjects who received the highest dose of VBI-1501A after three and two vaccinations, respectively. Management said that it is arranging a time to discuss the results with the regulatory agencies, in order to determine clinical trial design and next steps of development for VBI-1501A.
Figure 3. VBI-1501 was shown to induce gB antibody binding titers at all dose levels
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/VBI3.jpg" style="width: 507px;height: 281px" />
Source: Company Presentation 2018
 
The Phase 1/2a trial, evaluating VBI-1901 in patients with recurrent GBM, was initiated in in January 2018. The company &nbsp;stated that &nbsp;the immunologic data from ongoing biomarker analyses is to readout in Q4/2018, whereas 6-month overall survival (OS) and progression-free survival (PFS) data is anticipated in H1/2019. 
Key Catalysts:
VBI plans to:
<ul type="square">
<li>Release topline data from Phase 3 PROTECT clinical study of Sci-B-Vac in Hep-B in mid-2019 </li>
<li>Readout topline data from Phase 3 CONSTANT clinical study of Sci-B-Vac in Hep-B in H2/2019 </li>
<li>Release data from Phase 1/2a study of VBI-1901 in GBM in H2/2019 </li>
<li>Disclose next steps/clinical trial design of VBI-1501 in CMV in 2019</li>
</ul>
Stock Information
&nbsp;<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/VBI4.jpg" style="width: 640px;height: 355px" />
 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/VBI5.jpg" style="width: 636px;height: 281px" /> Source: Capital IQ

VBI Vaccines Inc. (VBIV)

Data Rich Year Ahead

Data Rich Year Ahead (VBIV)

Inbox Intel from Channelchek.