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MarketScreener Homepage  >  Equities  >  Nasdaq  >  VBI Vaccines Inc.    VBIV   CA91822J1030

VBI VACCINES INC.

(VBIV)
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VBI-2901: Pan-Coronavirus Vaccine Candidate Overview

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05/21/2020 | 03:59am EDT

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.

N A S D A Q : V B I V

2

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)

N A S D A Q : V B I V

3

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

N A S D A Q : V B I V

4

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

N A S D A Q : V B I V

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

N A S D A Q : V B I V

6

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

N A S D A Q : V B I V

7

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

N A S D A Q : V B I V

8

eVLP Pan-Coronavirus Trivalent Construct

Covid-19 Spikes

SARS Spikes

VBI-2901

MERS Spikes

Common Internal eVLP

Structural Protein

N A S D A Q : V B I V

9

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,

  1. 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,

  1. 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,

  1. 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

12

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

N A S D A Q : V B I V

13

Summary

N A S D A Q : V B I V

14

Sci-B-Vac®:Hepatitis B Prophylactic Vaccine

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

3VBI-2601:Hepatitis B Immunotherapeutic

  • H2 2020 -Initial human proof-of-concept Phase Ib/IIa data readout expected

4VBI-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®

N A S D A Q : V B I V

17

VBI Vaccines Inc.

222 Third Street, Suite 2241

Cambridge, MA 02142

  1. 830-3031
    info@vbivaccines.com

N A S D A Q : V B I V

18

Disclaimer

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

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