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DPX COVID-19

Drug Profile

DPX COVID-19

Alternative Names: Covid-19 viral vaccine - IMV; DPX COVID-19 vaccine - IMV

Latest Information Update: 28 May 2020

At a glance

  • Originator IMV
  • Class Peptide vaccines; Synthetic vaccines; Viral 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

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 01 Apr 2020 IMV conducted a pre-clinical meeting with Health Canada for phase I trial
  • 30 Mar 2020 IMV plans to conduct meeting with Health Canada to discuss design of phase I trial in April 2020
  • 30 Mar 2020 IMV plans a phase I trial for Covid-19 in Summer 2020

Development Overview

Introduction

DPX COVID-19 is a peptide vaccine being developed by IMV using its proprietary DPX drug delivery platform for the prevention of COVID-19 infections caused due to coronavirus (SARS-CoV-2). The technology consists of a target antigen and an adjuvant in a hydrophobic oil carrier encapsulated in a liposomal delivery system. DPX COVID-19 vaccine produces a depot effect that will significantly enhance vaccine-induced cell-mediated and humoral immunity. 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 neutralizing antibody responses and protective T cell responses. Preclinical development is ongoing in Canada.

Key Development Milestones

In April 2020, IMV conducted a pre-clinical meeting with the Health Canada, to finalise the design of a planned phase I trial in 84 healthy volunteers. The discussion was initiated in March 2020, for the submission of a clinical trial application (CTA). The trial was designed in collaboration with the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN). In addition, the company in collaboration with the University Laval, plans preclinical trials to evaluate safety and potency of DPX COVID-19, by utilising assays in animal models [1] [2] [3] .

Financing info

In March 2020, IMV announced that it has entered into an equity distribution agreement, with Piper Sandler & Co. as agent, pursuant to which the Company may, from time to time sell, through "at-the-market" offerings with Piper Sandler acting as sales agent such number of common shares as would have an aggregate offering price of up to $US30 million under the ATM Prospectus Supplement. The Company plans to use the net proceeds from this offering for general corporate purposes, including but not limited to working capital expenditures, capital expenditures, research and development expenditures, and clinical trial expenditures, including expenditures related to a COVID-19 vaccine candidate [4] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class 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

Future Events

Expected Date Event Type Description Updated
30 Sep 2020 Trial Update IMV plans a phase I trial for Covid-19 in Summer 2020 [5] 21 May 2020
20 Apr 2020 Regulatory Status IMV plans to conduct meeting with Health Canada to discuss design of phase I trial in April 2020 [2] 28 May 2020

Development History

Event Date Update Type Comment
01 Apr 2020 Regulatory Status IMV conducted a pre-clinical meeting with Health Canada for phase I trial [1] 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 [2] Updated 28 May 2020
30 Mar 2020 Trial Update IMV plans a phase I trial for Covid-19 in Summer 2020 [5] Updated 21 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) [2] 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

  1. IMV Announces Selection of a Vaccine Candidate Against COVID-19 to Advance Into Human Clinical Studies.

    Media Release
  2. IMV Inc. Provides Updates on the Development of DPX-COVID-19 Vaccine and Ongoing Business and Clinical Operations.

    Media Release
  3. A Phase 1, Randomized, Placebo-Controlled Clinical Study to Investigate the Clinical Safety and Immunogenicity of a Vaccine Candidate DPX-COVID-19

    ctiprofile
  4. IMV Inc. Establishes At-the-Market Facility.

    Media Release
  5. IMV Inc. Announces Fourth Quarter and Full Year 2019 Financial and Operational Results.

    Media Release
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