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Research programme: polytope monoclonal antibody therapeutics - ImmunoPrecise Antibodies

Drug Profile

Research programme: polytope monoclonal antibody therapeutics - ImmunoPrecise Antibodies

Alternative Names: PolyTope™ mAb

Latest Information Update: 30 Jun 2020

At a glance

  • Originator EVQLV; ImmunoPrecise Antibodies
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research COVID 2019 infections

Most Recent Events

  • 23 Nov 2020 ImmunoPrecise Antibodies plan a preclinical study in SARS-CoV-2 in ealy January 2021 in Netherlands
  • 13 Jul 2020 ImmunoPrecise Antibodies intends to initiate pre-clinical evaluations in Summer 2020
  • 22 Jun 2020 ImmunoPrescise Antibodies and LiteVax agree to conduct preclinical trials of polytope vaccine candidates for COVID-2019 infections

Development Overview

Introduction

Polytope monoclonal antibody candidates are being developed by ImmunoPrecise Antibodies (IPA) in collaboration with EVQLV for the treatment of COVID-19 infections. EVQLV, an artificial intelligence company will utilise B cell selectTM, Single Step Cloning Hybridoma, and custom DeepDisplayTM platforms developed at IPA. B cell selectTM platform enables the interrogation of B-cells to generate native monoclonal antibodies from any immunised animal, independent of species. DeepDisplayTM platform is a combination of phage display platform which contains immune libraries from different animal species including transgenic animals and Ligand's OmniAb therapeutic antibody platform which develop fully human antibody with reduced immunogenicity. EVQLV will perform in-silico antibody design to discover novel antibody sequence to leverage lead candidate from IPA's discovery platform. Early research is underway in US.

Company Agreements

In June 2020, ImmunoPrecise Antibodies (IPA) and LiteVax entered an R & D agreement to conduct preclinical studies for analysis of the immunogenicity, safety and potency of ImmunoPrecise Antibodies' SARS-CoV-2 vaccine candidates, upon being formulated with LiteVax’s Adjuvant (LVA). The studies have been completely funded by TRANSVAC2, a network of leading European groups working in the field of vaccine development. The aim of this collaboration is to conduct preclinical analyses with PA’s protein-based vaccine candidates that are formulated with LVA (adjuvant) and assess for the potent, neutralizing antibody responses against SARS-CoV-2 infection in a swine model. Protein-based vaccine candidates will be supplied by ImmunoPrecise and LVA will be supplied by LiteVax. According to the agreement, both companies will retain full rights to their respective proprietary assets and know-how used for the study. If the preclinical studies are a success, IPA and LiteVax may negotiate the terms for a preclinical study in a second animal model, and the details of the potential commercialization of any resulting vaccine. Financial details of the agreement have not been disclosed. [1]

In March 2020, ImmunoPrecise Antibody and EVQLV entered into research collaboration to develop lead therapeutic and vaccine candidate against COVID-19. Under the terms of the agreement, EVQLV will perform in silico antibody design and discovery to generate novel, optimized antibody sequences leveraging lead candidate data from IPA’s discovery technologies, as well as previously published sequences. EVQLV will utilise its in-silico antibody design to generate novel antibody sequence by using IPA's B cell selectTM and custom deep displayTM technology platform to discover lead candidate against SARS-CoV-2 coronavirus infection.

Key Development Milestones

In November 2020, ImmunoPrecise Antibodies announced nomination of the first cocktail consisting of four, human, synergistic antibodies to enter pre-clinical testing that will evaluate its safety, tolerability and efficacy in the well defined SARS-CoV-2, Syrian hamster model [2] .

ImmunoPrecise Antibodies, in July 2020, announced the identification of additional human lead antibody candidates against SARS-CoV-2, that demonstrate potent in vitro neutralizing activity, and have been discovered using Ligand's OmniRat® therapeutic human antibody platform [3] .In June 2020, ImmunoPrecise announced discovery of functional antibodies from the top 300 lead antibodies analysed from human and llama [4] .

In June 2020, ImmunoPrecise Antibodies announced that they intend to conduct preclinical trial with polytope monoclonal antibody candidates in collaboration with LiteVax in August 2020. The preclinical study will determine immunogenicity, safety and potency of the candidates with an adjuvant provided by LiteVax. The study will be funded by TRANSVAC2 [5] .

In March 2020, EVQLV submitted the first panel of candidate therapeutic antibody sequences, comprised of DNA sequences encoding for potentially therapeutic antibodies against the new coronavirus, SARS-CoV-2 [6] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Monoclonal antibodies
  • Target Undefined
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B (Antivirals, excluding anti-HIV products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA Parenteral / unspecified EVQLV, ImmunoPrecise Antibodies 18 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
EVQLV Originator USA
ImmunoPrecise Antibodies Originator Canada
EVQLV Owner USA
ImmunoPrecise Antibodies Owner Canada
Ligand Pharmaceuticals Technology Provider USA
LiteVax BV Collaborator Netherlands

Future Events

Expected Date Event Type Description Updated
01 Jan 2021 Trial Update ImmunoPrecise Antibodies plan a preclinical study in SARS-CoV-2 in ealy January 2021 in Netherlands [2] 01 Dec 2020
30 Dec 2020 Trial Update ImmunoPrecise Antibodies intends to initiate pre-clinical evaluations in Summer 2020 (9297738) 15 Jul 2020

Development History

Event Date Update Type Comment
23 Nov 2020 Trial Update ImmunoPrecise Antibodies plan a preclinical study in SARS-CoV-2 in ealy January 2021 in Netherlands [2] Updated 01 Dec 2020
13 Jul 2020 Trial Update ImmunoPrecise Antibodies intends to initiate pre-clinical evaluations in Summer 2020 [3] Updated 15 Jul 2020
22 Jun 2020 Licensing Status ImmunoPrescise Antibodies and LiteVax agree to conduct preclinical trials of polytope vaccine candidates for COVID-2019 infections [5] Updated 30 Jun 2020
18 Mar 2020 Phase Change Early research in Coronavirus infections in USA (Parenteral) (ImmunoPrecise Antibody Website, March 2020) Updated 26 Mar 2020
17 Mar 2020 Licensing Status ImmunoPrecise Antibodies and EVQLV entered into research collaboration to develop lead therapeutic and vaccine candidate against SARS-CoV-2 coronavirus infection Updated 26 Mar 2020

References

  1. Collaborative COVID-19 Vaccine Project Between ImmunoPrecise Antibodies Europe and LiteVax BV, Funded Through TRANSVAC2. Internet-Doc 2020;.

    Available from: URL: https://www.immunoprecise.com/collaborative-covid-19-vaccine-project-between-immunoprecise-antibodies-europe-and-litevax-bv-funded-through-transvac2/
  2. IPA Selects Polytope(Tm) Formulations for Pre-Clinical Studies.

    Media Release
  3. Functional, Human Antibodies Targeting SARS-CoV-2 Discovered Using IPA's Proprietary B cell Select(Tm) and Single Step Cloning Hybridoma Technologies.

    Media Release
  4. IPA Confirms Discovery of Fully Human, Potent, Neutralizing Antibodies Targeting SARS-CoV-2.

    Media Release
  5. Collaborative COVID-19 Vaccine Project Between ImmunoPrecise Antibodies Europe and LiteVax BV, Funded Through TRANSVAC2.

    Media Release
  6. ImmunoPrecise's Artificial Intelligence Partner, EVQLV, Submits First Panel of Optimized Antibody Sequences to Coronavirus for PolyTope(TM) mAb Therapy Program.

    Media Release
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