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Research programme: virus-like particle vaccines - VBI Vaccines

Drug Profile

Research programme: virus-like particle vaccines - VBI Vaccines

Alternative Names: CMV eVLP - VBI; eVLP vaccines - VBI; HCV eVLP - VBI; Prophylactic respiratory syncytial virus vaccine - VBI Vaccines; RSV vaccine - VBI Vaccines; VLP-based Cytomegalovirus - VBI

Latest Information Update: 28 Aug 2020

At a glance

  • Originator VBI Vaccines
  • Class Cancer vaccines; Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • No development reported Cytomegalovirus infections; Hepatitis C; Respiratory syncytial virus infections

Most Recent Events

  • 28 Aug 2020 No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA
  • 28 Oct 2019 No recent reports of development identified for research development in Respiratory-syncytial-virus-infections in Canada
  • 28 Oct 2018 No recent reports of development identified for preclinical development in Cytomegalovirus infections(Prevention) in Canada

Development Overview

Introduction

VBI Vaccines is developing prophylactic and therapeutic virus-like particle (VLP)-based vaccines for the prevention of cytomegalovirus (CMV), respiratory syncytial virus (RSV) and hepatitis C virus (HCV) infections. The vaccines are being developed based on Epixis' eVLP technology. The foundation of the eVLP technology is a stable, protein-based core on which additional vaccine antigens of interest can be added. eVLP-based vaccines are designed to mimic the target virus, but do not contain any infectious viral material. eVLPs impart greater immunity than immunisation with the same recombinant target protein alone due to their structural similarity to viruses. VBI Vaccines believes its HCV vaccine candidate may be capable of replacing interferon when used in combination with standard antivirals. Preclinical development in CMV and HCV infections is underway in Canada. Early research in RSV infections is underway in Canada.

VBI 2501 has emerged as a lead candidate from this research programme [see Adis Insight Drug Profile 800060416].

VBI 1901 being developed for the treatment of medulloblastoma and glioblastoma multiforme, has entered clinical development [see Adis Insight Drug Profile 800051104].

VBI 1501A has entered clinical development [see Adis Insight Drug Profile800045639].

VBI is seeking a partner to develop its HCV vaccine candidate.

In September 2011, Epixis was acquired by VBI Vaccines [1] .

As at October 2018, no recent reports of development had been identified for preclinical development in Hepatitis-C in Canada, preclinical development in Cytomegalovirus infections (Prevention) in Canada.

As at October 2019, no recent reports of development had been identified for research development in Respiratory-syncytial-virus-infections in Canada.

Company Agreements

In September 2014, VBI Cda signed a licensing agreement with Advanced Medical Research Institute of Canada (AMRIC), which provides AMRIC with the exclusive rights to IP related to VBI’s proprietary Variosite™ technology and SFV2 seasonal flu vaccine and a non-exclusive right to use an adjuvant formulation with Variosite™ vaccines including SFV2.Under this licensing agreement AMRIC will be responsible for all development costs (VBI Vaccines form 10-K filed in March 2015).

Key Development Milestones

In rhesus macaque models, administration of HCV eVLP indicated cross-reactive neutralising antibody responses against divergent genotypes of HCV.

Financing information

In October 2017, VBI Vaccines announced the pricing of its underwritten public offering and concurrent registered direct offering of its common shares, with a 30-day option to the underwriters in the public offering, to purchase additional shares. The company anticipates receipt of approximately $US63.5 million as aggregate gross proceeds, and intends to utilise the net proceeds from both offerings to progress its pipeline programme, including funding of the planned phase I/IIa clinical study of VBI 1901 for glioblastoma multiforme, and for general corporate purposes, including working capital and capital expenditures [2] . VBI vaccines announced an update to the deal with the registered direct offering was upsized from $US20.8 million to $US22.8 million. The pricing for the underwritten public offering was for a total of 16 100 000 common shares, which includes the additional 2 100 000 shares purchased by the underwriters pursuant to the exercised option, for expected gross proceeds of $US49.1 million. The pricing for the concurrent registered direct offering was for a total number of 7 475 410 common shares for expected gross proceeds of $US22.8 million [3] . In November 2017, VBI Vaccines announced the closing of its previously announced underwritten public offering of 16,100,000 common shares and its concurrent registered direct offering of 7,475,410 common shares at a price of US$3.05 per share and has raised net proceeds of US$71.9 million from this public offering and registered direct offering [4] .

In December 2016, VBI Vaccines raised $US23.6 million in equity and debt financing transactions. The company intends to use the proceeds towards development of its vaccine candidates [5] .

In September 2015, VBI Vaccines received a grant of $CAD350 000 from the National Research Council-Industrial Research Assistance Program (NRC-IRAP) for the development of respiratory syncytial virus (RSV) vaccine candidate using the company's eVLP platform [6] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class Cancer vaccines, Virus-like particle vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B (Viral Vaccines)

    J07B-C (Hepatitis vaccines)

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7 (Vaccines)

    J7E4 (Hepatitis vaccines)

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Cytomegalovirus infections - Prevention No development reported (Preclinical) Canada unspecified / unspecified VBI Vaccines 28 Oct 2018
Hepatitis C - - No development reported (Preclinical) Canada unspecified / unspecified VBI Vaccines 28 Oct 2018
Respiratory syncytial virus infections - - No development reported (Research) Canada unspecified / unspecified VBI Vaccines 28 Oct 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
VBI Vaccines Originator USA
VBI Vaccines Owner USA
Advanced Medical Research Institute of Canada Licensee Canada
National Research Council Canada Funder Canada

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
VBI Vaccines - Preclinical - 16 Jan 2018

Future Events

Expected Date Event Type Description Updated
31 Dec 2017 Trial Update VBI Vaccines plans a phase I/IIa trial for Glioblastoma (Recurrent, Second-line therapy or greater, Metastatic disease) in USA in the second half of 2017 [7] 16 Jan 2018

Development History

Event Date Update Type Comment
28 Aug 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA Updated 28 Aug 2020
28 Oct 2019 Phase Change - No development reported No recent reports of development identified for research development in Respiratory-syncytial-virus-infections in Canada Updated 28 Oct 2019
28 Oct 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Cytomegalovirus infections(Prevention) in Canada Updated 28 Oct 2018
28 Oct 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Hepatitis-C in Canada Updated 28 Oct 2018
15 Aug 2017 Trial Update VBI Vaccines plans a phase I/IIa trial for Glioblastoma (Recurrent, Second-line therapy or greater, Metastatic disease) in USA in the second half of 2017 [7] Updated 16 Jan 2018
19 Jul 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection in USA (unspecified route) (Prevention) Updated 21 Jul 2016
06 Nov 2015 Trial Update VBI Vaccines plans a phase I trial for Cytomegalovirus infections Updated 13 Nov 2015
08 Sep 2015 Company Involvement VBI Vaccines secures $CAD350 000 grant from National Research Council-Industrial Research Assistance Program to finance development of respiratory syncytial virus vaccine [6] Updated 15 Sep 2015
08 Sep 2015 Phase Change Early research in Respiratory syncytial virus infections in Canada (unspecified route) Updated 15 Sep 2015
21 Aug 2015 Licensing Status Advanced Medical Research Institute of Canada in-licenses Variosite™ technology and SFV2 seasonal flu vaccine and an adjuvant formulation with Variosite™ vaccines including SFV2 from VBI Cda (VBI Vaccines form 10-K filed in March 2015) Updated 26 Nov 2015
03 Nov 2014 Licensing Status The Hepatitis C vaccine candidate is available for licensing as of 03 Nov 2014. http://www.vbivaccines.com/hcv/ Updated 03 Nov 2014
15 Sep 2014 Phase Change - Preclinical Preclinical trials in Cytomegalovirus infections (Prevention) in Canada (unspecified route) Updated 03 Nov 2014
15 Sep 2014 Phase Change - Preclinical Preclinical trials in Hepatitis C in Canada (unspecified route) Updated 03 Nov 2014
30 Jun 2010 Phase Change Early research in Cytomegalovirus infections (Prevention) in Canada (unspecified route) Updated 28 Sep 2011
30 Jun 2010 Phase Change Early research in Hepatitis C in Canada (unspecified route) Updated 28 Sep 2011

References

  1. VBI Announces Acquisition of Epixis and its Innovative eVLP Vaccine Platform.

    Media Release
  2. VBI Vaccines Prices Concurrent Public Offering and Registered Direct Offering for Aggregate Proceeds of $63.5 Million.

    Media Release
  3. VBI Vaccines Announces Full Exercise of Underwriters Option to Purchase Additional Sharesand Upsized Registered Direct Offering for Aggregate Proceeds of $71.9 Million.

    Media Release
  4. VBI Vaccines Announces Closing of Public Offering and Concurrent Registered Direct Offering of Common Shares.

    Media Release
  5. VBI Vaccines Closes $23.6 Million Financing from Perceptive Advisors.

    Media Release
  6. VBI Vaccines Awarded NRC-IRAP Funding to Leverage its eVLP Platform in the Development of a Novel RSV Vaccine Candidate.

    Media Release
  7. VBI Vaccines Announces FDA Acceptance of Investigational New Drug Application for VBI-1901 to Treat Glioblastoma Multiforme.

    Media Release
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