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AV 001 - AdaptVac

Drug Profile

AV 001 - AdaptVac

Alternative Names: AV001 - AdaptVac

Latest Information Update: 03 Apr 2020

At a glance

  • Originator AdaptVac
  • Class Antineoplastics; Cancer vaccines; Immunotherapies; Virus-like particle vaccines
  • 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 No

Highest Development Phases

  • Preclinical Breast cancer
  • Research Adult respiratory distress syndrome; COVID 2019 infections

Most Recent Events

  • 30 Mar 2020 Early research in Adult respiratory distress syndrome in USA (unspecified route)
  • 30 Mar 2020 Early research in COVID-2019 infections in USA (unspecified route)
  • 26 Feb 2020 AdaptVac signs an option to license agreement with ExpreS2 ion Biotechnologies to develop AV 001

Development Overview

Introduction

AV 001 is a vaccine being developed by AdaptVac (joint-venture between ExpreS2ion Biotechnologies and NextGen Vaccines,a spin-out of the University of Copenhagen) for the treatment of cancer including HER2-positive breast cancer and Covid-19 infections, pathogen induced acute respiratory distress syndrome (ARDS). AdaptVac uses combination of ExpreS2ion Biotechnologies' proprietary ExpreS2 technology platform and a proprietary virus-like particle (VLP) technology of the University of Copenhagen. AV 001 activate the Tie2 receptor and restore normal barrier defense in the vasculature. Preclinical development is ongoing in USA. Early research is underway for COVID-19 infections and acute respiratory distress syndrome in the US.

ExpreS2 platform is a non-viral insect cell expression system that establishes stable polyclonal pools that provide high protein expression levels without selection pressure. The system is designed for transient or stable transfections using vector DNA containing a very strong proprietary hybrid promoter. The virus-like particle (VLP) technology employs VLPs which are enabled to bind efficiently to various vaccine antigens via a genetically engineered binding-tag on the VLP surface. The company utilises the split-protein conjugation system to generate stable isopeptide bound antigen-VLP complexes by simply mixing of the antigen and VLP components.

Company Agreements

In February 2020, AdaptVac signed an option to license agreement with ExpreS2 ion Biotechnologies, whereby ExpreS2 ion may call an option to exclusively license in AV 001, which ExpreS2 ion plans to develop towards human clinical studies. According to the agreement, ExpreS2 ion has the right to call the option to license in AV 001 within 12 months. The option can entail a maximum amount of DKK 1.2M during the full option term. Under the terms of the license agreement, that ExpreS2 ion can opt to execute anytime within 12 months, will contain financial consideration to AdaptVac in the form of an upfront payment at signature of DKK 2.5M (SEK 3.5M), a payment at approval of release of clinical-ready production material of DKK 2.5M (SEK 3.5M) (estimated to be in 2021), a payment for initiation of a clinical Phase I safety trial of DKK 2.5M (SEK 3.5M) (estimated to be in 2022), a payment for initiation of a clinical Phase II efficacy trial of DKK 10M (SEK 14M) (estimated to be in 2023-24) and thereafter aggregated clinical Phase III development and regulatory milestone-based payments of DKK 200M (SEK 285M), and lower single-digit royalty rates of net sales. ExpreS2 ion under the License Agreement plans to develop AV 001 (HER2-cVLP) until it is clinically validated and ready for partnering. Furthermore, the agreement includes sublicensing rights allowing ExpreS2 ion to partner with a larger biopharmaceutical company on the further commercialisation of AV 001, against a fixed percentage of partner payments to be paid by ExpreS2 ion to AdaptVac, in which case remaining financial consideration towards AdaptVac falls away. [1]

Key Development Milestones

Financing information

In March 2020, AdaptVac received an Horizon 2020 EU grant of €2.7M as part of the PREVENT-nCoV consortium. The company intends to use the funds for development of the coronavirus vaccine [see Adis Insight Drug Profile800057768] as well as to support production of the needed clinical supply of viral capsid-like particles for clinical projects, including as AV 001 [2] .

Patent Information

In January 2020, AdaptVac was granted patent by the USPTO for its “Virus-like particle with efficient epitope display" covering its virus-like particle (VLP) based vaccine treatment for HER2-positive breast cancer. The patent provides intellectual property protection for the U.S. market of AdaptVac’s novel viral capsid-like particle (CLP) technology platform, and any vaccine produced using it [3]

In September 2018, AdaptVac received a notice of allowance in the US for its patent application US 20 180 125 954 A1.The patent is related to the use of VLP-based vaccine for the prophylaxis and/or treatment of a diseases including, but not limited to, cancer, cardiovascular, infectious, chronic, neurological, asthma, immune-inflammatory diseases or disorders. The patent was filed by the University Of Copenhagen with the priority date of January 2015, and once approved, the patent will be valid until January 2025 [4] .

As of September 2018, AdaptVac has pending patent applications for its HER2 breast cancer vaccine in the US and Europe [4] .

In July 2018, the University Of Copenhagen was granted a German patent number DE 16 703 049 T1, entitled "Virus-like particle with efficient epitope display", covering its virus-like particle (VLP) based vaccine, in Germany. The patent is related to a vaccine for use in the prevention and/or treatment of a disease. The vaccine is comprised of a virus capsid protein comprising a first peptide tag, and an antigen which is fused to a second peptide tag, wherein the antigen and the virus capsid protein are connected via an isopeptide bond between the first and the second peptide tag, and wherein both form a virus-like particle, which is the antigen.

The University Of Copenhagen has pending patent applications CA 3 010 975 A1, EP 3 244 915 A1, EP 3 368 068 A1, WO 2016 112 921 A1 and WO 2017 071 713 A1 entitled "Virus like particle with efficient epitope display", covering its virus-like particle (VLP) based vaccine. The patent relates to a technology and method for making a virus-like particle based vaccine with efficient epitope display and capable of inducing a strong and long-term protective immune response. The patent is related to the use of VLP-based vaccine for the prophylaxis and/or treatment of a diseases including, but not limited to, cancer, cardiovascular, infectious, chronic, neurological, asthma, allergy, immune-inflammatory diseases or disorders.

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antineoplastics, Cancer vaccines, Immunotherapies, Virus-like particle vaccines
  • Target TIE-2 receptor
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J07B-X (Other viral vaccines)

    L (Antineoplastic and Immunomodulating Agents)

    R07 (Other Respiratory System Products)

  • EPhMRA code

    J7E9 (All other viral vaccines)

    L (Antineoplastic and Immunomodulating Agents)

    R7X (All Other Respiratory System Products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Adult respiratory distress syndrome - - Research USA unspecified / unspecified AdaptVac 24 Mar 2020
Breast cancer - - Preclinical USA Parenteral / unspecified AdaptVac 01 Mar 2018
COVID 2019 infections - - Research USA unspecified / unspecified AdaptVac 24 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
AdaptVac Originator Denmark
AdaptVac Owner Denmark
University of Copenhagen Technology Provider Denmark
ExpreS2ion Biotechnologies Technology Provider Denmark

Future Events

Expected Date Event Type Description Updated
31 Dec 2024 Trial Update AdaptVac plans a phase II efficacy trial for Breast cancer in 2023 or 2024 [1] 28 Feb 2020
31 Dec 2022 Trial Update AdaptVac plans a phase I safety trial for Breast cancer in 2022 [1] 28 Feb 2020

Development History

Event Date Update Type Comment
30 Mar 2020 Phase Change Early research in Adult respiratory distress syndrome in USA (unspecified route) Updated 03 Apr 2020
30 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (unspecified route) Updated 03 Apr 2020
26 Feb 2020 Licensing Status AdaptVac signs an option to license agreement with ExpreS2 ion Biotechnologies to develop AV 001 [1] Updated 28 Feb 2020
26 Feb 2020 Trial Update AdaptVac plans a phase I safety trial for Breast cancer in 2022 [1] Updated 28 Feb 2020
26 Feb 2020 Trial Update AdaptVac plans a phase II efficacy trial for Breast cancer in 2023 or 2024 [1] Updated 28 Feb 2020
08 Jan 2020 Patent Information AdaptVac receives patent and has patent protection for Virus-like particle with efficient epitope display platform in USA. [3] Updated 08 Jan 2020
10 Sep 2018 Patent Information AdaptVac has patents pending for its HER2 breast cancer vaccine in USA and Europe [4] Updated 18 Sep 2018
10 Sep 2018 Patent Information AdaptVac receives patent allowance for virus like particle-based vaccine for the treatment of HER2-positive breast cancer in USA [4] Updated 18 Sep 2018
12 Jul 2018 Patent Information AdaptVac and the University Of Copenhagen has patent protection for virus like particle-based vaccine in Germany Updated 18 Sep 2018
01 Mar 2018 Phase Change - Preclinical Preclinical trials in Breast cancer in USA (Parenteral) Updated 24 Oct 2018
15 Jan 2015 Patent Information AdaptVac and the University Of Copenhagen has patents pending for virus like particle-based vaccine in Canada, Europe and World Updated 18 Sep 2018

References

  1. AdaptVac Signs AV001 Option to License Agreement with ExpreS2 ion.

    Media Release
  2. AdaptVac's ground-breaking technology central to new EUR2.7M EU grant funded COVID-19 vaccine effort.

    Media Release
  3. Granting of AdaptVac's core platform technology patent in the United States.

    Media Release
  4. ExpreS2ion's joint venture, AdaptVac, receives notice of allowance in the U.S. for its breast cancer vaccine patent.

    Media Release
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