VBI-2901:Pan-Coronavirus Vaccine Candidate
Overview
N A S D A Q : V B I V
N A S D A Q : V B I V | M AY 2 0 2 01 |
Forward-Looking Statements
Certain statements in this presentation 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 securities laws (collectively "forward-looking statements"). The company cautions that such statements involve risks and uncertainties that may materially affect the company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products, including the approval of Sci-B-Vac® in the U.S., Europe, and Canada following the completion of its recent Phase 3 studies; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the Company's filings with the Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, and may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Overview of VBI Vaccines
- Leveraging significant immunology expertise to address unmet medical needs in bothINFECTIOUS DISEASEand IMMUNO-ONCOLOGY
- Advancing prevention and treatment ofHEPATITIS B:
- Sci-B-Vac®: Only tri-antigenic Hepatitis B vaccine; recently completed a Phase III program in the U.S., Europe, and Canada; approved and marketed in Israel
- VBI-2601:Immuno-therapeutic in development in a collaboration with Brii Biosciences for a functional cure for chronic Hepatitis B
- Leveraging a proprietary envelopedvirus-like particle (eVLP) platform technology to develop next-generation vaccines:
- VBI-1901:GLIOBLASTOMA(GBM) vaccine immunotherapeutic candidate (currently in Phase I/IIa study)
- VBI-2901:PAN-CORONAVIRUS(COVID-19, SARS, MERS) vaccine candidate in development in a collaboration with the National Research Council of Canada
- VBI-1501: Prophylactic CMVvaccine candidate (positive topline Phase I data announced in May 2018)
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VBI Vaccines Pipeline
PRE- | PHASE I | PHASE II PHASE III APPROVED | STATUS | |||||||
CLINICAL | ||||||||||
INFECTIOUS DISEASE | ||||||||||
•Approved for use and | ||||||||||
Hepatitis B - | Sci-B-Vac® | commercially-available in Israel | ||||||||
Prophylaxis | VLP | • | Regulatory submissions in U.S., | |||||||
Europe, and Canada expected to | ||||||||||
begin Q4 2020 | ||||||||||
Hepatitis B - | VBI-2601 | •License & collaboration agreement | ||||||||
• | with Brii Biosciences | |||||||||
Therapeutic | VLP | Initial Phase Ib/IIa data expected | ||||||||
H2 2020 | ||||||||||
Cytomegalovirus (CMV) | VBI-1501 | • | Positive Phase I data announced | |||||||
eVLP | May 2018 | |||||||||
Pan-Coronavirus | VBI-2901 | • | Development collaboration with | |||||||
(COVID-19, SARS, MERS) | eVLP | NRC announced March 2020 | ||||||||
Zika | VBI-2501 | • | Candidate selected from NRC | |||||||
eVLP | collaboration | |||||||||
IMMUNO-ONCOLOGY | ||||||||||
• | Ongoing Phase I/IIa | |||||||||
Glioblastoma (GBM) | VBI-1901 | • | Expanded immunologic data | |||||||
eVLP | expected mid-year 2020 and Q4 | |||||||||
2020 | ||||||||||
VBI-1901 | ||||||||||
Other CMV+ Tumors | • | Preclinical work ongoing | ||||||||
eVLP | ||||||||||
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Vaccine Platforms Targeting COVID-19
Name | COVID-19 | Live Virus or | Recombinant | Virus Like Particle |
Vector | Protein | |||
Class | RNA Virus | Live or Live | Subunit - simple | Subunit - complex |
Attenuated | ||||
Key Structural | "Enveloped" with | Replicating virus, | Focuses on Spike | Virus-mimic |
Features | "Spike" Protein | with COVID | protein | including Spike |
swapped in | protein | |||
Pros | Similar to SARS & | Looks like a virus | Cheap, scalable, | Safe, Looks like a |
virus to immune | ||||
MERS | to immune | safe | ||
system, Spike | ||||
system | ||||
adopts native | ||||
Cons | Highly infectious, | Those in use not | Less | shape |
virulent, | structurally | immunogenic, | Timelines similar | |
mutating? | similar to | proteins adopt | to Virus or | |
COVID19 | different shape | Recombinant | ||
The Enemy | Approved Products | |||
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DNA | mRNA |
Nucleic Acid | Nucleic Acid |
None, code | None, code |
injected & proteins | injected & proteins |
produced internally | produced internally |
Cheap, fast to | Cheap, fast to clinic |
clinic, good T-cell | |
responses | |
Limited antibodies, | Limited data |
No approved | available, product |
products since | is produced inside |
1987 | body (or not) |
No Approved Products | |
5 |
Advantages of the Enveloped Virus-Like Particle (eVLP)
Technology PlatformElectron Microscopy image of VBI's CMV eVLPs captured at
Scripps Institute
Lipid Bilayer | ||
MLV Gag creates | ||
eVLP | Virus-Like Structure | |
T-Cell Antigen |
Surface Antigen(s)
Potential for surface immunomodulatory proteins
- Highly Immunogenic:Because of their structural similarity to viruses found in nature, vaccination with a target protein expressed in an eVLP is capable of imparting greater immunity than vaccination with the same recombinant target protein alone
- Customizable:eVLPs are highly-customizable, which allows VBI to rationally design preventative or therapeutic vaccine candidates by controlling the expression of both surface and internal target proteins of interest
- Safe:eVLPs do not contain any infectious genetic machinery and have proven to be safe and well tolerated in clinical studies, with no vaccine-related safety signals observed
- Commercially Viable:eVLPs are manufactured and purified using highly-scalable methods
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Multiple eVLP Candidates have Clinical & Preclinical Proof-of-Concept
Infectious Disease | Immuno-Oncology | ||||||
Prophylactic CMV | Prophylactic Zika | Therapeutic CMV+ Tumors | Immuno-Oncology | ||||
(VBI-1501) | (VBI-2501) | (VBI-1901) | (VBI-2701) | ||||
Schematic | |||||||
Construct Design | Monovalent: | Bivalent:Modified-E / | Bivalent: gB / pp65 | Bivalentwith Immuno- | |||
(major CD4, CD8 & Ab | |||||||
Modified gB-G | NS1 | modulatory protein | |||||
epitopes) | |||||||
Adjuvant | Alum | Alum | GM-CSF | Self Adjuvanted | |||
Most Advanced | Ph I complete | Preclinical | Ph I/II ongoing | Preclinical | |||
Development Stage | |||||||
• | Modified gB elicits | •Modified-E enhances | • | Internal antigen | • | Immunomodulatory | |
fibroblast & epithelial | neutralizing responses | expression elicits T cell | |||||
proteins can enhance | |||||||
Key Features | cell neutralization | •NS1 T cell response | immunity | ||||
antigen-specific Th1 | |||||||
• | Qualitatively enhanced | • | Stimulates innate | ||||
enhances antibody | immunity | ||||||
neutralizing response | response & protection | immunity | |||||
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eVLP Approach to a Pan-Coronavirus Vaccine Candidate
Coronaviruses are members of the "enveloped" class of viruses
COVID-19
- Morphology:
- Enveloped RNA virus with a predominant S1/S2 spike
- RNA viruses are prone to genetic drift/shift (though coronaviruses
seem to be more stable than most)
- Key Target Antigen:
- Based on knowledge of SARS and MERS, it is anticipated that the spike protein (S1/S2) is likely a neutralizing determinant and an ideal target for inclusion in a vaccine
- The spike protein is trimeric - eVLPs encourage trimerization and expression of native conformation of proteins
- Based on past experience with the eVLP platform, VBI expects that a multivalent eVLP vaccine candidate, co- expressingSARS-CoV-2,SARS-CoV, and MERS-CoV spike proteins on the same particle, will be possible
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eVLP Pan-Coronavirus Trivalent Construct
Covid-19 Spikes
SARS Spikes
VBI-2901 | MERS Spikes |
Common Internal eVLP
Structural Protein
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How trivalent eVLP vaccination may enrich for highly potent cross- reactive immunity
Y Y Y
Vaccination/ | Y |
virus exposure | |
Y | |
Variant 1 | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Repeat exposure to the
same viral variant gradually increases the 1) frequency,
- specificity, and 3) affinity/potency over time.
Low affinity | Intermediate affinity | High affinity/potency |
10
How trivalent eVLP vaccination may enrich for highly potent cross- reactive immunity
Y Y Y
Vaccination/
virus exposure
Variant 1
Y Y Y
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Repeat exposure to the
same viral variant gradually increases the 1) frequency,
- specificity, and 3) affinity/potency over time.
Y | ||
Y | Y | Y |
Y | ||
Y | Y | Y |
Y | Y | Y |
Y |
Y Y Y Y Y Y
Exposure to one viral variant
followed by subsequent
exposure to another leads to greater breadth of immunity but with only moderate affinity/potency.
Low affinity | Intermediate affinity | High affinity/potency |
11
How trivalent eVLP vaccination may enrich for highly potent cross- reactive immunity
Y Y Y
Vaccination/
virus exposure
Variant 1
Y Y Y
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Y | Y |
Repeat exposure to the
same viral variant gradually increases the 1) frequency,
- specificity, and 3) affinity/potency over time.
Y Y Y
Variant 1
Y Y Y
Y | |
Y | |
Y | |
Y | |
Y | Variant 2 |
Y |
Y Y Y Y Y Y
Exposure to one viral variant
followed by subsequent
exposure to another leads to greater breadth of immunity but with only moderate affinity/potency.
Y Y Y
Variant 1
Variant 2
Y Y Y
Potential | Y |
Y | |
Variant 3 | |
Y | |
Y | |
Y | |
Y |
Y Y Y Y Y Y
Repeat exposure to multiple
viral variants gradually increases the frequency, breadth, and affinity/potency over time.
Low affinity | Intermediate affinity | High affinity/potency |
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VBI-2901(Pan-Coronavirus) : Program Milestones
- March 2020: Announcement of collaboration with the National Research Council of Canada (NRC) to develop a pan-coronavirus vaccine candidate targeting COVID-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS)
- Collaboration will combine VBI's viral vaccine expertise, eVLP technology platform, and coronavirus antigens with the NRC'suniquely-designedCOVID-19 antigens and assay development capabilities
- IND-enablingpre-clinical studies will be conducted at both the NRC core facilities and at VBI's research facility in Ottawa, Canada
- Q4 2020: Clinical study materials expected to be available for human clinical studies
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Summary
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Summary
A N T I C I PAT E D C ATA LY S T S T H R O U G H 2 0 2 0 Y E A R - E N D : 1•
- Q2 2020 -Pre-BLA discussions expected with FDA
- Beginning Q4 2020-Submissions of applications for regulatory approvals in the U.S., Europe, and Canada expected to begin
2 | |
• | VBI-1901:GBM Vaccine Immunotherapeutic (Immuno-Oncology) |
- Mid-year2020 -Expanded immunologic and tumor response data as well as potentially-predictive biomarker data expected from VBI-1901 + GM-CSF Phase IIa (Part B) study arm
- Q4 2020-Initial immunologic data expected from VBI-1901 + AS01BPhase IIa (Part B) study arm
3•VBI-2601:Hepatitis B Immunotherapeutic
- H2 2020 -Initial human proof-of-concept Phase Ib/IIa data readout expected
4•VBI-2901:Pan-Coronavirus Prophylactic Vaccine
- Q4 2020 -Clinical study materials expected to be available
N A S D A Q : V B I V | 15 |
VBI Vaccines Leadership
M A N A G E M E N T
Jeff Baxter
President & CEO
Dr. David Anderson, Ph.D.
Chief Scientific Officer
Dr. Francisco Diaz-Mitoma, M.D., Ph.D.
Chief Medical Officer
Chris McNulty
Chief Financial Officer
Nell Beattie
Chief Business Officer
Avi Mazaltov
Global Head of Manufacturing
SciVac General Manager
B O A R D O F D I R E C T O R S
Dr. Steve Gillis, Ph.D.
Chairman
Damian Braga
Joanne Cordeiro
Dr. Michel De Wilde, Ph.D.
Blaine H. McKee, Ph.D.
N A S D A Q : V B I V | 16 |
VBI Vaccines Global Footprint
H E A D Q U A R T E R S - C A M B R I D G E , M A
- 7 FTEs (Incl. CEO, CSO, CFO, CBO)
- Central location in biotechnology hub
R E S E A R C H O P E R AT I O N S - O T TA W A , C A N A D A
- ~35 FTEs (Incl. CMO)
- R&D team and facility
M A N U F A C T U R I N G F A C I L I T Y - R E H O V O T, I S R A E L
- ~80 FTEs
- GMP manufacturing facility for the production ofSci-B-Vac®
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VBI Vaccines Inc.
222 Third Street, Suite 2241
Cambridge, MA 02142
-
830-3031
info@vbivaccines.com
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VBI Vaccines Inc. published this content on 20 May 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 May 2020 07:58:11 UTC