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 - VBILatest Information Update: 28 Jan 2022
At a glance
- Originator VBI Vaccines
- Class Antineoplastics; Cancer vaccines; Viral vaccines; Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Preclinical Cancer; Cytomegalovirus infections
- No development reported Hepatitis C; Respiratory syncytial virus infections
Most Recent Events
- 28 Jan 2022 Preclinical development in Cytomegalovirus infections (Prevention) is ongoing in Canada (VBI Vaccines pipeline, January 2022)
- 28 Jan 2022 Virus-like particle vaccines - VBI Vaccines is available for licensing as of 28 Jan 2022. https://www.vbivaccines.com/
- 01 Jan 2022 Preclinical trials in Cancer in Canada (Parenteral) before January 2022 (VBI Vaccines pipeline, January 2022)
Development Overview
Introduction
VBI Vaccines is developing prophylactic and therapeutic virus-like particle (VLP)-based vaccines for the prevention of cytomegalovirus (CMV) infection, and for the treatment of cancer. 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 infections and cancer is underway in Canada.
Preclinical development of VLP vaccines for the treatment of hepatitis C virus infection, and early research in RSV infections was conducted in Canada. As at October 2019, no recent reports of development had been identified for these indications.
VBI 1901, VBI 1501A and VBI 2501 have progresses into clinical development [see Adis Insight Drug profiles 800051104, 800045639 and 800060416].
In September 2011, Epixis was acquired by VBI Vaccines [1] .
VBI Vaccines is actively seeking partners for its product development (VBI Vaccines pipeline, January 2022)
Company Agreements
In September 2014, VBI Vaccines signed a licensing agreement with Advanced Medical Research Institute of Canada (AMRIC). Under the terms of the agreement, AMRIC gained 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. 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
- Route of administration Parenteral
- Formulation unspecified
- Class Antineoplastics, Cancer vaccines, Viral vaccines, Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B (Viral Vaccines)
J07B-C (Hepatitis vaccines)
J07B-X (Other viral vaccines)
L01 (Antineoplastic Agents)
-
EPhMRA code
J7 (Vaccines)
J7E4 (Hepatitis vaccines)
J7E9 (All other viral vaccines)
L1 (Antineoplastics)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Cancer | - | - | Preclinical | Canada | Parenteral / unspecified | VBI Vaccines | 01 Jan 2022 |
| Cytomegalovirus infections | - | Prevention | Preclinical | Canada | Parenteral / unspecified | VBI Vaccines | 28 Jan 2022 |
| Hepatitis C | - | - | No development reported (Preclinical) | Canada | Parenteral / unspecified | VBI Vaccines | 28 Oct 2018 |
| Respiratory syncytial virus infections | - | - | No development reported (Research) | Canada | Parenteral / 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 | - | Unspecified | - | 28 Jan 2022 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Jan 2022 | Active Status Review | Preclinical development in Cytomegalovirus infections (Prevention) is ongoing in Canada (VBI Vaccines pipeline, January 2022) Updated 28 Jan 2022 |
| 28 Jan 2022 | Licensing Status | Virus-like particle vaccines - VBI Vaccines is available for licensing as of 28 Jan 2022. https://www.vbivaccines.com/ Updated 28 Jan 2022 |
| 01 Jan 2022 | Phase Change - Preclinical | Preclinical trials in Cancer in Canada (Parenteral) before January 2022 (VBI Vaccines pipeline, January 2022) Updated 28 Jan 2022 |
| 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 |
| 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
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VBI Announces Acquisition of Epixis and its Innovative eVLP Vaccine Platform.
Media Release -
VBI Vaccines Prices Concurrent Public Offering and Registered Direct Offering for Aggregate Proceeds of $63.5 Million.
Media Release -
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 -
VBI Vaccines Announces Closing of Public Offering and Concurrent Registered Direct Offering of Common Shares.
Media Release -
VBI Vaccines Closes $23.6 Million Financing from Perceptive Advisors.
Media Release -
VBI Vaccines Awarded NRC-IRAP Funding to Leverage its eVLP Platform in the Development of a Novel RSV Vaccine Candidate.
Media Release
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