DPX COVID 19
Alternative Names: Covid-19 viral vaccine - IMV; DPX COVID-19; DPX COVID-19 vaccine - IMVLatest Information Update: 30 Dec 2020
At a glance
- Originator IMV
- Class COVID-19 vaccines; Peptide vaccines; Synthetic vaccines; Viral 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 COVID 2019 infections
Most Recent Events
Development Overview
Introduction
DPX COVID 19 is a synthetic peptide vaccine being developed by IMV, using its proprietary DPX drug delivery platform for the prevention of COVID-2019 infections caused due to coronavirus (SARS-CoV-2). The patented technology consists of a target antigen and an adjuvant in a hydrophobic oil carrier encapsulated in a liposomal delivery system. Multiple peptides of the spike protein of coronavirus are formulated in DPX platform. DPX COVID-19 vaccine produces a depot effect that will significantly enhance vaccine-induced cell-mediated and humoral immunity. The technology is expected to be utilised for the production of a vaccine that is agreeable to older and more vulnerable populations. The vaccine is being designed based on third-party immunological studies of SARS-CoV and third-party sequencing data available for SARS-CoV-2 with the goal of selecting potentially immunogenic epitopes within the virus that induce neutralising antibody responses and protective T cell responses. The vaccine is capable of being developed as a lyophilised formulation, amenable to storage at 2°C to 8°C, for long term stability and cold chain management with existing infrastructure. Preclinical development is ongoing in Canada.
IMV intends to secure additional non-dilutive funding and strike agreements with commercial partners for continued clinical development of DPX COVID-19 vaccine [1] .
Company Agreements
In October 2020, IMV entered into a collaborative manufacturing agreement with an undisclosed global manufacturing partner and initiated transfer and scale-up activities of DPX COVID-19 vaccine. The collaboration potentially, intends to usher in two additional production sites in India and Europe, to boost production capacity to several hundred million doses of the vaccine. [1]
Key Development Milestones
In March 2021, IMV reported that the company is conducting additional preclinical studies to evaluate DPX COVID 19 vaccine response against new emerging variants of SARS-CoV-2 virus [2] .
In October 2020, IMV reported its intention of combining its two independent planned phase I and II trials into a single phase I/II trial of DPX COVID 19 vaccine after consulting with Health Canada, to speed up clinical development and overall project timeline. The trial design will include two-age strata cohorts (18-55 years old and over 55 years old) as originally decided. Earlier, in August 2020, IMV filed a clinical trial application for the trial. In April 2020, IMV conducted a pre-clinical meeting with Health Canada, to finalise the design of the planned trial in 84 healthy volunteers. The planned trial was designed in collaboration with the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) [1] [3] [4] [5] [6] .
In December 2020, updated preclinical data were released by IMV [7]
In August 2020, preclinical safety, GLP toxicology and challenge studies for DPX COVID 19 vaccine were underway. These studies are required to be conducted, prior to the commencement of planned phase I/II trial [1] .
In July 2020, IMV released preclinical data of DPX COVID 19 vaccine tested in animal models [8] .
Financing information
In August 2020, IMV received $CA4.75 million funding from Canadian government agencies, $CA4.15 million advisory services and funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), Atlantic Canada Opportunities Agency (ACOA) and Next Generation Manufacturing Canada (NGen) and $CA600 000 from the NRC IRAP Innovation Assistance Program. The company will use the proceeds to advance phase I clinical development of DPX COVID 19, for the prevention of COVID-2019 infection. Furthermore, in October 2020, IMV reported that the NRC IRAP committed advisory services and an additional funding of up to $CA5.4 million in support of the continuation of clinical trials for DPX COVID-19 vaccine. This additional funding, which brought the total funded figure to approximately $CA10 million from multiple government sources, was approved by Government of Canada following a review of DPX COVID 19 vaccine [1] [3] .
In March 2020, IMV entered into an equity distribution agreement, with Piper Sandler to sell its common shares at an aggregate offering price of up to $US30 million. The company plans to use the net proceeds from this offering for general corporate purposes, working capital expenditures, capital expenditures, research and development expenditures, and clinical trial expenditures, including expenditures related to a COVID 19 vaccine candidate [9] .
Patent Information
IMV has patent protection for its proprietary DPX drug delivery platform [1] .
Drug Properties & Chemical Synopsis
- Formulation unspecified
- Class COVID-19 vaccines, Peptide vaccines, Synthetic vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Preclinical | Canada | unspecified / unspecified | IMV | 18 Mar 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| IMV | Originator | Canada |
| IMV | Owner | Canada |
| Dalhousie University | Collaborator | Canada |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| IMV | - | Clinical Phase Unknown | - | 08 Oct 2020 |
Scientific Summary
Immunogenicity
Preclinical studies have demonstrated the capacity of DPX COVID-19 to induce strong immunogenicity including the binding on target to the spike protein and viral neutralization [8] .
Preclinical studies demonstrated long-term protection with antibody titers maintained throughout the duration of studies (Day 140). Preclinical studies in ferrets demonstrated reduction of viral load in the nasal tissue [7]
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 20 Apr 2020 | Regulatory Status | IMV plans to conduct meeting with Health Canada to discuss design of phase I trial in April 2020 [5] | 28 May 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 29 Dec 2020 | Scientific Update | Immunogenicity data from a preclinical study in COVID-2019 infections released by IMV [7] Updated 30 Dec 2020 |
| 08 Oct 2020 | Licensing Status | DPX COVID 19 is available for licensing as of 08 Oct 2020. www.imv-inc.com Updated 13 Oct 2020 |
| 08 Oct 2020 | Patent Information | IMV has patent protection for DPX drug delivery platform technology [1] Updated 13 Oct 2020 |
| 15 Aug 2020 | Scientific Update | IMV initiates preclinical safety, GLP toxicology and challenge studies in COVID-2019 infections (Prevention) [1] Updated 13 Oct 2020 |
| 05 Aug 2020 | Trial Update | IMV plans to initiate a phase I/II trial for Covid-2019 infections (Prevention, In adults, In the elderly) in USA and Canada by the end of 2020 [3] [8] [1] Updated 19 Mar 2021 |
| 04 Aug 2020 | Regulatory Status | IMV files a clinical trial application with Health Canada in Canada for COVID-2019 infections, before August 2020 [3] Updated 11 Aug 2020 |
| 14 Jul 2020 | Scientific Update | Immunogenicity data from a preclinical trial in Covid-19 infections released by IMV [8] Updated 16 Jul 2020 |
| 01 Apr 2020 | Regulatory Status | IMV conducted a pre-clinical meeting with Health Canada for phase I trial [4] Updated 28 May 2020 |
| 30 Mar 2020 | Regulatory Status | IMV plans to conduct meeting with Health Canada to discuss design of phase I trial in April 2020 [5] Updated 28 May 2020 |
| 20 Mar 2020 | Trial Update | IMV plans a phase I trial for COVID-2019-infections (Prevention) Updated 27 Mar 2020 |
| 18 Mar 2020 | Regulatory Status | IMV announces intention to submit clinical trial application (CTA) to Health Canada for COVID-2019 infections (Prevention) [5] Updated 02 Apr 2020 |
| 18 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Canada (unspecified route) before March 2020 Updated 27 Mar 2020 |
References
-
IMV Provides Updates On COVID-19 Vaccine Program.
Media Release -
IMV Inc. Announces Fourth Quarter and Full Year 2020 Financial and Operational Results.
Media Release -
IMV Receives Funding From Canadian Governmental Agencies for COVID-19 Vaccine Phase 1 Clinical Study.
Media Release -
IMV Announces Selection of a Vaccine Candidate Against COVID-19 to Advance Into Human Clinical Studies.
Media Release -
IMV Inc. Provides Updates on the Development of DPX-COVID-19 Vaccine and Ongoing Business and Clinical Operations.
Media Release -
A Phase 1/2, Randomized, Placebo-Controlled Clinical Study to Investigate the Clinical Safety and Immunogenicity of a Vaccine Candidate DPX-COVID-19
ctiprofile -
IMV Reports Update on COVID-19 Vaccine Program.
Media Release -
IMV Updates Rapid Progress on COVID-19 Vaccine Program.
Media Release -
IMV Inc. Establishes At-the-Market Facility.
Media Release
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