Research programme: coronavirus vaccine - Vaxil BioTherapeutics
Alternative Names: Corvax; COVID-19 vaccine - Vaxil BioTherapeuticsLatest Information Update: 04 Dec 2021
At a glance
- Originator Vaxil BioTherapeutics
- Class COVID-19 vaccines; Peptide 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 - Coronavirus infections
Highest Development Phases
- Suspended COVID 2019 infections
Most Recent Events
Development Overview
Introduction
Coronavirus vaccine candidates are being developed by Vaxil BioTherapeutics using its proprietary VaxHitTM bioinformatics platform, for the prevention of COVID-2019 infections. Vaxil BioTherapeutics is developing 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 is being developed as an oral formulation and injection. 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 was underway in Israel, however in May 2021, Vaxil BioTherapeutics placed a temporary hold on COVID-19 vaccine work [1] .
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 candidates, VXL 301, VXL 302 and VXL 303 are advancing for the development [see AdisInsight drug profiles800058106, 800058171 and 800058176], respectively.
Company Agreements
In October 2020, Vaxil entered into a cooperative research and development agreement (CRADA) with U.S. Army Medical Research Institute of Infectious Diseases to evaluate CorVax™ for the prevention of COVID-2019 infection in mice. [2]
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.
[3]
Key Development Milestones
As of March 2022, regarding the potential application of oral delivery to COVID-19, Vaxil BioTherapeutics is exploring whether there is value in conducting experiments of the oral formulation of the potential COVID-19 vaccine candidate in combination with mRNA vaccines to boost T-cell protection to future variants [4] .
In May 2021, Vaxil placed a temporary hold on its COVID-19 vaccine work, considering the evolution of COVID-19 vaccine market and the success of early entrants. The company announced its intention to focus and use its resources on oral delivery development as well as its other development programs [1] .
In December 2020, Vaxil BioTherapeutics initiated an exploratory preclinical study to determine the viability of administering orally its COVID-19 vaccine candidate (Corvax™). As of January 2021, Vaxil completed the exploratory oral experiment. An immune response was observed in some animals after oral delivery of the vaccine candidate [5] [6] .
In September 2020, results from preclinical studies were released by Vaxil BioTherapeutics [7] .
In July 2020, Vaxil BioTherapeutics initiated in vivo animal studies for the COVID-19 vaccine candidate (Corvax™) to evaluate the immune response to and also dosed with the first animal with the Corvax™ injections. In August 2020, the company completed the dosing in preclinical studies [8] .
In April 2020, Vaxil BioTherapeutics initiated a preclinical development in Israel and announced positive preclinical data that demonstrated favorable immunogenicity profile [9] [9] [10] .
Financing Information
In December 2020, Vaxil BioTherapeutics announced that the second and final tranche of previously announced non-brokered private placement of gross proceeds $US 264,100 was completed. The net proceeds will be utilised to further expand and expedite preclinical and manufacturing development of CorVax™ and development of ImMucin™ [see Adis Insight Drug profile 800031812] [11] .
In November 2020, Vaxil BioTherapeutics announced that the first tranche of previously announced non-brokered private placement ofr gross proceeds $US 542 858 was complete. the net proceeds will be utilised to further expand and expedite preclinical and manufacturing development of CorVax™ and development of ImMucin™ [12] .
In June 2020, Vaxil Bio Therapeutics raised in a private placement to raise gross proceeds of upto $US2 million. The net proceeds will be used 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 [13]
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. The 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 [14] .
In March 2020, Vaxil Therapeutics received aggregate proceeds of $US1 047 000 from the exercise of previously issued warrants. These funds will be used to advance the company’s research program [15] .
In March 2020, Vaxil BioTherapeutics closed on $US36 000 worth of convertible debenture proceeds, along with $US95 000 worth of non-convertible debenture proceeds. The aggregate debenture proceeds will be used as a bridge financing to fund coronavirus vaccine, including the manufacture of the product for clinical trials [16] [17] .
Patent Information
In March 2021, Vaxil BioTherapeutics filed an international patent application for its anti-infective vaccine platform, specifically for 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 [18] .
In March 2020, Vaxil BioTherapeutics filed US patent application on coronavirus vaccine that intended to provide coverage for a broader set of vaccine candidates [15] .
In March 2020, Vaxil BioTherapeutics filed US patent application number US 62 987 310 for a coronavirus vaccine. The patent claims will provide broad patent protection for vaccines, pharmaceutical compositions and methods of treating and preventing an infectious disease as well as methods for producing a peptide vaccine against coronaviruses [19] .
In June 2016, the European Patent Office granted Vaxil a Notice of Allowance for a European patent application number EP 07 827 143.4 entitled "Antigen Specific Multi Epitope Vaccines" covering the VaxHit™ platform and all immunotherapy products derived from it [20] .
Drug Properties & Chemical Synopsis
- Route of administration Parenteral, PO
- Formulation Injection, unspecified
- Class COVID-19 vaccines, Peptide vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7 (Vaccines)
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Research programme: coronavirus vaccine - Vaxil BioTherapeutics | Alkaline phosphatase (ALPL) | Eligibility Criteria |
| gamma-glutamyltransferase 2 | Eligibility Criteria | |
| gamma-glutamyltransferase light chain 1 | Eligibility Criteria | |
| gamma-glutamyltransferase light chain 3 | Eligibility Criteria | |
| GGT | Eligibility Criteria | |
| GGTLC4P | Eligibility Criteria | |
| GGTLC5P | Eligibility Criteria | |
| LOC102724197 | Eligibility Criteria | |
| vitronectin | Arm Group Description, Brief Title, Official Title |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | Prevention | Suspended (Preclinical) | Israel | PO / unspecified | Vaxil BioTherapeutics | 31 May 2021 |
| COVID 2019 infections | - | Prevention | Suspended (Preclinical) | Israel | Parenteral / Injection | Vaxil BioTherapeutics | 31 May 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Vaxil BioTherapeutics | Originator | Israel |
| Vaxil BioTherapeutics | Owner | Israel |
| United States Army Medical Research Institute of Infectious Diseases | Funder | USA |
| 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 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Corvax | Vaxil BioTherapeutics | COVID 2019 infections | - |
Scientific Summary
Pharmacodynamics
Summary
Results from preclinical studies in mouse models showed that the vaccine generated both cellular and humoral responses. Inoculation of three injections in two mouse strains showed that both the strains exhibited a humoral response, developing antibodies as early as 10 days after last injection. Both strains also displayed activated T cells against the signal peptides [7] .
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 [9] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 02 Dec 2021 | Biomarker Update | Biomarkers information updated Updated 04 Dec 2021 |
| 31 May 2021 | Phase Change - Suspended(Preclinical) | Suspended - Preclinical for COVID-2019 infections (Prevention) in Israel (Parenteral) [1] Updated 02 Jun 2021 |
| 31 May 2021 | Phase Change - Suspended(Preclinical) | Suspended - Preclinical for COVID-2019 infections (Prevention) in Israel (PO) [1] Updated 02 Jun 2021 |
| 11 Mar 2021 | Patent Information | Vaxil BioTherapeutics files for patent protection for corona virus vaccine [18] Updated 17 Mar 2021 |
| 03 Dec 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Israel (PO) [6] Updated 08 Dec 2020 |
| 26 Oct 2020 | Company Involvement | Vaxil establishes CRADA with U.S. Army Medical Research Institute of Infectious Diseases for the development of CorVax in COVID-2019 infections [2] Updated 28 Oct 2020 |
| 26 Oct 2020 | Trial Update | Vaxil plans pre-clinical and clinical programs for COVID-2019 infections [2] Updated 28 Oct 2020 |
| 08 Sep 2020 | Scientific Update | Pharmacodynamics data from a preclinical studies in COVID-2019 infections released by Vaxil BioTherapeutics [7] Updated 10 Sep 2020 |
| 05 May 2020 | Licensing Status | Vaxil BioTherapeutics and Tel Aviv Ichilov Medical Center enter a collaboration to develop Coronavirus vaccines [3] Updated 10 May 2020 |
| 13 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in Israel (Parenteral) prior to April 2020 [9] Updated 16 Apr 2020 |
| 13 Apr 2020 | Scientific Update | Immunogenicity data from a preclinical study in COVID-2019 infections released by Vaxil BioTherapeutics [9] Updated 16 Apr 2020 |
| 26 Mar 2020 | Patent Information | Vaxil files for patent protection for coronavirus vaccine in USA [15] Updated 31 Mar 2020 |
| 10 Mar 2020 | Patent Information | Vaxil files for patent protection for coronavirus vaccine in USA [19] Updated 16 Mar 2020 |
| 04 Mar 2020 | Trial Update | Vaxil BioTherapeutics plans clinical trial in COVID-2019 infections [16] 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) [10] Updated 21 Feb 2020 |
| 16 Jun 2016 | Patent Information | Vaxil receives patent allowance for VaxHit™ in European Union [20] Updated 27 Feb 2020 |
References
-
Vaxil Provides Research and Development Update.
Media Release -
Vaxil Enters Into a Cooperative Research and Development Agreement With U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).
Media Release -
Vaxil Announces Collaboration Agreement With The Tel Aviv Sourasky Medical Center (Ichilov Hospital), Israels Leading Tertiary Care Facility.
Media Release -
Vaxil Provides Update on Research Activities.
Media Release -
Vaxil Provides Update on USAMRIID, Oral Experiment and Other General Business Matters.
Media Release -
Vaxil Provides Business Update on Corvax(Tm) Experiments.
Media Release -
Vaxil Announces Positive Results on CorVax(Tm) in vivo Study.
Media Release -
Vaxil Provides Update on In Vivo Study.
Media Release -
CORRECTION: VAXIL PROVIDES UPDATE ON PRECLINICAL EXPERIMENT.
Media Release -
Vaxil Provides Clarification and Further Information on the Possible Identification of a Corona Virus Vaccine.
Media Release -
Vaxil Announces Close of Second and Final Tranche of Previously Announced Non-Brokered Private Placement for Gross Proceeds of $264,100.
Media Release -
Vaxil Announces Close of First Tranche of Previously Announced Non-Brokered Private Placement for Gross Proceeds of $542,858.
Media Release -
Vaxil Announces Private Placement Extension- 29 June 2020.
Media Release -
Vaxil Announces Brokered Private Placement.
Media Release -
VAXIL COMMENCES PRECLINICAL COVID-19 VACCINE TRIAL AND FILES AN ADDITIONAL COVID-19 PATENT.
Media Release -
Vaxil Announces Closing of Bridge Financing and Provides Update on Corona Virus Vaccine Work.
Media Release -
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/ -
Vaxil Announces 2021 Reseach and Development Strategy and Progress.
Media Release -
VAXIL APPLIES FOR CORONAVIRUS VACCINE PATENT UNDER ITS ANTI-INFECTIVE VACCINES PLATFORM AND PROVIDES UPDATE ON THE EXERCISE OF WARRANTS.
Media Release -
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/
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