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Research programme: coronavirus vaccine - Vaxil BioTherapeutics

Drug Profile

Research programme: coronavirus vaccine - Vaxil BioTherapeutics

Alternative Names: COVID-19 vaccine - Vaxil BioTherapeutics

Latest Information Update: 10 May 2020

At a glance

  • Originator Vaxil BioTherapeutics
  • Class Peptide 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
  • Available For Licensing Yes - Coronavirus infections

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 13 Apr 2020 Preclinical trials in COVID-2019 infections (Prevention) in Israel (Parenteral) prior to April 2020
  • 13 Apr 2020 Immunogenicity data from a preclinical study in COVID-2019 infections released by Vaxil BioTherapeutics
  • 26 Mar 2020 Vaxil files for patent protection for coronavirus vaccine in USA

Development Overview

Introduction

Vaxil BioTherapeutics is developing coronavirus vaccine candidates by using its proprietary VaxHitTM bioinformatics platform, for the prevention of COVID-2019 infections. Vaxil BioTherapeutics developing three peptide vaccines based on patent protected signal peptide technology VaxHit™ that enables in-silico identification of signal peptides by combining proprietary algorithms. These signal peptides induce a robust T- and B-cell response across wide and varied HLA subtypes. The peptide platform specifically activates the immune system to recognise and attack the affected cells. The technology is based on the ability of selected sequences to bind simultaneously to multiple alleles of both MHC I and MHC II molecules. The vaccine candidate's design is hinged on favorable in vivo experiments conducted with the company's tuberculosis signal peptide vaccine [see AdisInsight Drug profile 800031810]. Preclinical development is underway in Israel.

Vaxil BioTherapeutics is actively exploring partnership opportunities for the continued development and future commercialisation of its coronavirus vaccine (Vaxil BioTherapeutics website, February 2020).

Three coronavirus vaccine candidate VXL 301, VXL 302 and VXL 303 are advancing for the development [see AdisInsight drug profiles800058106, 800058171 and 800058176, respectively].

Company Agreements

In May 2020, Vaxil Bio entered a collaboration agreement with the Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to advance the research program to develop a potential peptide vaccine against COVID-19. Under the terms of the agreement, Tel Aviv Medical Center will progress preclinical studies and clinical trials. The company will also gain access to the Center’s research resources including their unique bank of biological samples and its advanced research infrastructure. Further details of the agreement were not disclosed.
[1]

Key Development Milestones

In April 2020, Vaxil BioTherapeutics initiated a preclinical development in Israel and announced positive preclinical data that demonstrated favorable immunogenicity profile [2] [2] [3] .

Financing Information

In May 2020, Vaxil Bio Therapeutics announced that it is engaged in a private placement to raise gross proceeds of upto $US3 million subject to the company’s receipt of minimum gross proceeds of $US2 million. Net proceeds from the offering will be used by the company for preclinical research supporting development of the company’s pipeline including COVID-19 vaccine candidate, oncology and other infectious disease immunotherapies, as well as for general corporate purposes [4] .

In March 2020, Vaxil Therapeutics received aggregate proceeds of $US1 047 000 from the exercise of previously issued (January 2018) warrants, having an exercise price of $US0.10 per warrant. These funds will be applied to advancing the Company’s research program [5] .

In March 2020, Vaxil BioTherapeutics closed on $US36 000 worth of convertible debenture proceeds from third parties, along with $US95 000 worth of non-convertible debenture proceeds, constituting a part of a larger offering, for maximum proceeds of $US164 000. At this time, the company also reported that $US69 000 of debentures remained to be placed. Aggregate proceeds from the debenture proceeds, the convertible debenture proceeds and the warrant proceeds are slated to be used as a bridge financing to fund coronavirus vaccine, including the manufacture of the product for clinical trials [6] [7] .

Patent Information

In March 2020, Vaxil BioTherapeutics filed US patent application on coronavirus vaccine that intended to provide coverage for a broader set of vaccine candidates [5] .

In March 2020, Vaxil BioTherapeutics filed US patent application No. 62/987,310 on a coronavirus vaccine that is intended to provide broad patent protection for novel vaccines, pharmaceutical compositions and methods of treating and preventing an infectious disease as well as methods for producing a peptide vaccine against coronaviruses [8] .

In June 2016, the European Patent Office granted Vaxil a Notice of Allowance for a European patent application No. 07 827 143.4 entitled "Antigen Specific Multi Epitope Vaccines" covering the VaxHit™ platform and all immunotherapy products derived from it [9] .

In July 2016, the Canadian Intellectual Property Office (CIPO) granted the patent 2 665 816 entitled "Antigen Specific Multi Epitope Vaccines", which protects Vaxil's ownership of all signal peptides of the MUC1 cancer target [10] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Peptide vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7 (Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical Israel Parenteral / unspecified Vaxil BioTherapeutics 13 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Vaxil BioTherapeutics Originator Israel
Vaxil BioTherapeutics Owner Israel
Tel-Aviv Ichilov Medical Center Collaborator Israel

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Vaxil BioTherapeutics Coronavirus infections Research World 18 Feb 2020

Scientific Summary

Immunogenicity

In preclinical studies in healthy donor blood cells, signal peptides demonstrated a positive favorable immune response. Proliferation was observed in varying degrees in T cell population (CD3+), cytotoxic T lymphocytes (CD8+) and more prominently in T helper cells (CD4+). The individual peptides or in combination, all were responded in varying degrees, more than unstimulated cells, whereas, VXL 301 responded less as compared to other peptides. The most pronounced response was observed in T helper cells (CD4+). These responses were comparable to those observed for cancer vaccine MUC 1 and demonstrated same safety profile [2] .

Development History

Event Date Update Type Comment
05 May 2020 Licensing Status Vaxil BioTherapeutics and Tel Aviv Ichilov Medical Center enter a collaboration to develop Coronavirus vaccines [1] Updated 10 May 2020
13 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in Israel (Parenteral) prior to April 2020 [2] Updated 16 Apr 2020
13 Apr 2020 Scientific Update Immunogenicity data from a preclinical study in COVID-2019 infections released by Vaxil BioTherapeutics [2] Updated 16 Apr 2020
26 Mar 2020 Patent Information Vaxil files for patent protection for coronavirus vaccine in USA [5] Updated 31 Mar 2020
10 Mar 2020 Patent Information Vaxil files for patent protection for coronavirus vaccine in USA [8] Updated 16 Mar 2020
04 Mar 2020 Trial Update Vaxil BioTherapeutics plans clinical development in COVID-2019 infections [6] Updated 11 Mar 2020
18 Feb 2020 Licensing Status Coronavirus vaccine - Vaxil BioTherapeutics is available for licensing in World as of 18 Feb 2020. http://www.vxlbio.com Updated 27 Feb 2020
18 Feb 2020 Phase Change Early research in COVID-2019-infections (Prevention) in Israel (unspecified route) [3] Updated 21 Feb 2020
12 Jul 2016 Patent Information Vaxil has patent protection for VaxHit ™ in Canada [10] Updated 27 Feb 2020
16 Jun 2016 Patent Information Vaxil receives patent allowance for VaxHit™ in European Union [9] Updated 27 Feb 2020

References

  1. Vaxil Announces Collaboration Agreement With The Tel Aviv Sourasky Medical Center (Ichilov Hospital), Israels Leading Tertiary Care Facility.

    Media Release
  2. CORRECTION: VAXIL PROVIDES UPDATE ON PRECLINICAL EXPERIMENT.

    Media Release
  3. Vaxil Provides Clarification and Further Information on the Possible Identification of a Corona Virus Vaccine.

    Media Release
  4. Vaxil Announces Brokered Private Placement.

    Media Release
  5. VAXIL COMMENCES PRECLINICAL COVID-19 VACCINE TRIAL AND FILES AN ADDITIONAL COVID-19 PATENT.

    Media Release
  6. Vaxil Announces Closing of Bridge Financing and Provides Update on Corona Virus Vaccine Work.

    Media Release
  7. VAXIL ANNOUNCES THE IDENTIFICATION OF A POTENTIAL CORONA VIRUS VACCINE AND PROVIDES AN UPDATE IN THE PREVIOUSLY ANNOUNCED DEBT FINANCING. Internet-Doc 2020;.

    Available from: URL: https://vxlbio.com/vaxil-announces-the-identification-of-a-potential-corona-virus-vaccine-and-provides-an-update-in-the-previously-announced-debt-financing/
  8. VAXIL APPLIES FOR CORONAVIRUS VACCINE PATENT UNDER ITS ANTI-INFECTIVE VACCINES PLATFORM AND PROVIDES UPDATE ON THE EXERCISE OF WARRANTS.

    Media Release
  9. VAXIL RECEIVES POSITIVE RESPONSE FROM EUROPEAN PATENT OFFICE FOR THE ALLOWANCE OF THE IMMUNOTHERAPY ORPHAN DRUG DESIGNATED IMMUCIN? Internet-Doc 2020;.

    Available from: URL: https://vxlbio.com/vaxil-receives-positive-response-from-european-patent-office-for-the-allowance-of-the-immunotherapy-orphan-drug-designated-immucin/
  10. Antigen specific multi epitope vaccines. Internet-Doc 2020;.

    Available from: URL: https://patentimages.storage.googleapis.com/48/e4/55/c729327bbf35fb/CA2665816C.pdf
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