TNX 1800
Alternative Names: Coronavirus vaccine - Tonix Pharmaceuticals; COVID-19 vaccine - Tonix Pharmaceuticals; Live modified horsepox virus vaccine - Tonix Pharmaceuticals; TNX-1800Latest Information Update: 08 Apr 2024
At a glance
- Originator Tonix Pharmaceuticals Holding Corp
- Class COVID-19 vaccines; Recombinant proteins; Viral 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
Highest Development Phases
- Preclinical COVID 2019 infections
Most Recent Events
- 01 Apr 2024 Preclinical development in COVID-2019 infections(Prevention) is ongoing in USA (Topical) (Tonix Pharmaceuticals pipeline, April 2024)
- 28 Mar 2024 No recent reports of development identified for preclinical development in COVID-2019-infections(Prevention) in USA (Topical)
- 02 Nov 2023 Tonix Pharmaceuticals Holding Corp in collaboration with National Institute of Allergy and Infectious Diseases plans a phase I trial in COVID-2019 infections (Prevention) (Topical), in the second half of 2024
Development Overview
Introduction
TNX 1800 is a live modified horsepox virus vaccine for percutaneous administration, being developed by Tonix Pharmaceuticals, in collaboration with Southern Research, for the prevention of COVID-2019 infections. The company is using its proprietary horsepox virus technology that developed vaccine engineered to express relevant protein antigens from the virus that causes COVID-19. The horsepox has the potential to serve as a vector for vaccines to protect against other infectious agents. TNX 1800 is designed to express the spike protein from the virus that causes COVID-19 (SARS-CoV-2) and to induce T cell response. The protein synthesis connected with a replicating live virus vaccine provides direct antigen presentation, which stimulates cellular immunity in addition to humoral immunity. Preclinical development is underway in the US.
Company Agreements
In February 2023, Tonix Pharmaceuticals has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19. The licensed mAbs were developed as part of a research collaboration and option agreement between Tonix and Columbia University, originally announced in 2020. In September 2021, Tonix Pharmaceuticals expanded its research collaboration agreement with Columbia University for the development of COVID-2019 vaccines and antibody-based therapeutics. The research collaboration is focused on studying immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic, as well as studying in vitro T cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19. In July 2020, Tonix Pharmaceuticals entered into a research collaboration and option agreement with Columbia University for the development of humanized antibodies and idiotypes for COVID-19 infections. Under the terms of agreement, the research collaboration will focus on T cell and antibody responses against SARS-CoV-2 at the cellular level. [1] [2] [3]
In June 2020, Tonix Pharmaceuticals expanded its collaboration with Southern Research to include a study of T cell immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. In February 2020, Tonix Pharmaceuticals entered into a research and development collaboration with Southern Research to develop TNX 1800 for the prevention of COVID-2019 infections, based on Tonix’s proprietary horsepox vaccine platform. Under the terms of the agreement, Southern Research will test one or more vaccine constructs in the Tonix horsepox vector that express one or more proteins or protein fragments from the virus that causes COVID-19. The collaboration seeks to leverage Tonix’s horsepox vaccine technology originally developed to protect against smallpox but has capabilities as a vector for other infectious diseases. [4] [5]
In June 2020, Tonix Pharmaceuticals entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies for TNX 1800 a COVID-19 vaccine. According to the terms of the agreement, FUJIFILM Diosynth Biotechnologies will develop a manufacturing process, manufacture, and stock a supply of TNX 1800 at FDB’s College Station, Texas. FUJIFILM Diosynth Biotechnologies will provide contract manufacturing and development services to support the manufacturing of TNX 1800, for clinical trial supply.
[6]
Key Development Milestones
In November 2023, Tonix Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a phase I trial with TNX 1800 to protect against COVID-2019 infections. NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the US FDA to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform. The trial is expected to start in the second half of 2024 [7] .
In September 2021, Tonix Pharmaceuticals announced that it received the official written response from a Type B pre-Investigational New Drug (IND) meeting with the US FDA to develop TNX 1800 as a potential SARS-CoV-2 vaccine to protect against COVID-19 infections treatment. The written response provides a path to agreements on the design of a phase I trial and the overall clinical development plan to qualify TNX 1800 as a vaccine to prevent COVID-2019 infection. Based on the response, the company expects to begin phase I trial in the first half of 2022 [8] .
As of September 2021, Tonix Pharmaceuticals reported positive preclinical efficacy data from animal studies of TNX 1800 in the first quarter of 2021 [8] .
In October 2020, Tonix Pharmaceuticals announced that the first patient was enrolled in the observational PRECISION trial (TNX-C002) to examine responses to SARS-CoV-2 in volunteers who have recovered or were asymptomatic after exposure to COVID-2019 infections. This research is part of collaboration between Tonix Pharmaceuticals and Columbia University that focuses on T cell and antibody responses to CoV-2 [9] .
In September 2020, Tonix Pharmaceuticals announced that the first patient was enrolled in the observational COV-LOGIC trial (TNX-C001), a trial of humoral (antibody) and cellular (T cell) immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-2019 infections. This research is part of collaboration between Tonix Pharmaceuticals and Southern Research to develop and conduct animal testing of TNX 1800 [10] .
In November 2020, Tonix Pharmaceuticals released results from the studies conducted in non-human primates, which compared TNX 1800 to TNX 801 [see Adis Insight drug profile 800040866]and placebo [11] . In March 2021, Tonix Pharmaceuticals released positive efficacy, tolerability and pharmacokinetics data from the second phase of the non-human primates study of TNX 1800 vaccine for the prevention of COVID-2019 infections. The vaccine candidate protected both upper and lower airways after challenge with live SARS-CoV-2, through intra-nasal and intra-tracheal routes, suggesting an ability to block forward transmission [12] .
As of February 2020, modified horsepox virus vaccine was in pre-IND stage of the development [4] [13] .
Patent Information
In February 2021, Tonix Pharmaceuticals filed International Patent Application number PCT/US2021/020 119 (as well as applications in two non-PCT countries) and US Application number 17/187 678, entitled "Recombinant Poxvirus Based Vaccine Against SARS-CoV-2". These applications are directed to synthetic poxviruses comprising a SARS-CoV-2 protein, poxvirus delivery vectors for SARS-CoV-2 proteins and methods of using these modified poxviruses to protect individuals against COVID-19 [14] .
As of May 2020, Tonix Pharmaceuticals has filed a provisional patent for technology related to TNX 1800 (Tonix Pharmaceuticals website, May 2020).
Drug Properties & Chemical Synopsis
- Route of administration Topical
- Formulation unspecified
- Class COVID-19 vaccines, Recombinant proteins, 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 | USA | Topical / unspecified | Tonix Pharmaceuticals Holding Corp | 26 Feb 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Tonix Pharmaceuticals Holding Corp | Originator | USA |
| Tonix Pharmaceuticals Holding Corp | Owner | USA |
| Columbia University | Collaborator | USA |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
| Southern Research | Collaborator | England |
Scientific Summary
Pharmacokinetics
In a non-human primates study, all of the 16 animals vaccinated with either doses of TNX 1800 or the control TNX 801 manifested a “take” (cutaneous response) as a biomarker signaling that the horsepox vector elicits a strong T cell immune response in the vaccinated animals [12] .
Adverse Events
In a non-human primates study, TNX 1800 (modified horsepox virus encoding CoV-2 spike protein) was found to be well-tolerated at both the tested doses (high and low dose) [12] .
Pharmacodynamics
Summary
Preclinical studies:
In a preclinical study, animals vaccinated with TNX 1800 had undetectable SARS-CoV-2 in their upper and lower airways six days after challenge with SARS-CoV-2. Animals vaccinated with TNX 1800 manifested both neutralizing antibodies and a ‘take’, which is a skin reaction to horsepox vaccination that also serves as a validated biomarker of functional T cell immunity [8] .
Immunogenicity
Summary
Updated second phase non-human primates study results demonstrated significant immunogenicity and protective efficacy of single-dose TNX 1800, assessed at two dose levels (n=4 per group). Animals were challenged with live SARS-CoV-2 through intra-nasal (1 x 106 TCID50) and intra-tracheal (1 x 106 TCID50) routes at day 41 post vaccination and protection was assessed at day 47 i.e. six days after viral infection challenge. All eight vaccinated animals presented undetectable SARS-CoV-2 virus (not more than 1,000 genome copies of SARS-CoV-2) in their upper (by oropharyngeal swabs) and lower airways (by tracheal lavage), tested using qRT-PCR and neutralizing antibody titers of (=1:1280 titer), even six days after viral challenge. The level of neutralizing anti-SARS-CoV-2 antibody production was similar between the low and high dose TNX 1800 groups (1 x 106 Plaque Forming Units [PFU] and 3 x 106 PFU, respectively). Besides, neutralizing antibodies for unvaccinated animals followed by SARS-CoV-2 challenge, were measurable after vaccination (=1:40 titer) but were lower and appeared later than neutralizing antibodies in TNX 1800 vaccinated animals. The results were obtained from five groups (TNX 1800 high and low dose; TNX 801 high and low dose and placebo) included four animals [12] .
Earlier results from the non-human primates study showed that at day 14 after vaccination, all eight TNX 1800 vaccinated non-human primates presented anti-CoV-2 neutralizing antibodies (=1:40 titer) compared to none of the eight TNX 801 vaccinated control animals, or any of the four animals in the placebo group. The level of neutralizing anti-CoV-2 antibody production was similar between the low and high dose TNX-1800 groups ((1 x 106 Plaque Forming Units [PFU]) and 3 x 106 PFU, respectively). Both TNX 1800 and TNX 801 were safe and well tolerated. Cutaneous response was showed by all 16 animals vaccinated with either dose of TNX 1800 or the control TNX 801, indicating T cell immune response [11] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2024 | Trial Update | Tonix Pharmaceuticals Holding Corp in collaboration with National Institute of Allergy and Infectious Diseases plans a phase I trial in COVID-2019 infections (Prevention) (Topical), in the second half of 2024 [7] | 09 Nov 2023 |
| 30 Jun 2022 | Trial Update | Tonix Pharmaceuticals plans a phase I trial for COVID 2019 infections (Prevention) in the first half of 2022 [15] | 15 May 2021 |
| 30 Jun 2022 | Regulatory Status | The US FDA approves IND application for TNX 1800 in COVID-2019 infections in the first half of 2022 [15] | 15 May 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 01 Apr 2024 | Active Status Review | Preclinical development in COVID-2019 infections(Prevention) is ongoing in USA (Topical) (Tonix Pharmaceuticals pipeline, April 2024) Updated 08 Apr 2024 |
| 28 Mar 2024 | Phase Change - No development reported | No recent reports of development identified for preclinical development in COVID-2019-infections(Prevention) in USA (Topical) Updated 28 Mar 2024 |
| 02 Nov 2023 | Trial Update | Tonix Pharmaceuticals Holding Corp in collaboration with National Institute of Allergy and Infectious Diseases plans a phase I trial in COVID-2019 infections (Prevention) (Topical), in the second half of 2024 [7] Updated 09 Nov 2023 |
| 23 Sep 2021 | Licensing Status | Tonix Pharmaceuticals expands its collaboratation with Columbia University for development of COVID-2019 vaccines [2] Updated 27 Sep 2021 |
| 15 Sep 2021 | Regulatory Status | Tonix Pharmaceuticals Holding Corp receives the official written response from a Type B pre-Investigational New Drug (IND) meeting with the US FDA [8] Updated 15 Sep 2021 |
| 10 May 2021 | Regulatory Status | The US FDA approves IND application for TNX 1800 in COVID-2019 infections in the first half of 2022 [15] Updated 15 May 2021 |
| 10 May 2021 | Trial Update | Tonix Pharmaceuticals plans a phase I trial for COVID 2019 infections (Prevention) in the first half of 2022 [15] Updated 15 May 2021 |
| 30 Apr 2021 | Scientific Update | Pharmacodynamic data from preclinical studies in COVID-2019 infections released by Tonix Pharmaceuticals Holding Corp [8] Updated 15 Sep 2021 |
| 17 Mar 2021 | Regulatory Status | Tonix Pharmaceuticals anticipates IND clearance by the US FDA for TNX 1800 in COVID 2019 infections [12] Updated 01 Apr 2021 |
| 17 Mar 2021 | Scientific Update | Updated immunogenicity, tolerability and pharmacokinetics data from a preclinical study in COVID-2019 infections released by Tonix Pharmaceuticals [12] Updated 19 Mar 2021 |
| 26 Feb 2021 | Patent Information | Tonix Pharmaceuticals has patent pending for TNX 1800 in USA and outside USA [14] Updated 20 Apr 2022 |
| 16 Nov 2020 | Scientific Update | Immunogenicity data from a preclinical studies in COVID-2019 infections released by Tonix Pharmaceuticals [11] Updated 24 Nov 2020 |
| 16 Jul 2020 | Licensing Status | Tonix Pharmaceuticals enters in a research collaboration and option agreement with Columbia University for development of COVID-2019 vaccines [1] Updated 27 Sep 2021 |
| 18 Jun 2020 | Licensing Status | Tonix Pharmaceuticals expands its collaboratation with Southern Research to further develop TNX-1800 for COVID-2019 infections [4] Updated 23 Jun 2020 |
| 18 Jun 2020 | Trial Update | Tonix Pharmaceuticals plans human clinical trials for COVID-2019 infections [5] Updated 23 Jun 2020 |
| 12 May 2020 | Patent Information | Tonix Pharmaceuticals has patent pending for technology related to TNX 1800 (Tonix Pharmaceuticals website, May 2020). Updated 22 May 2020 |
| 12 May 2020 | Regulatory Status | Tonix Pharmaceuticals announces intention to submit IND to regulatory bodies for COVID-2019 infections (Prevention) Updated 22 May 2020 |
| 26 Feb 2020 | Licensing Status | Tonix Pharmaceuticals collaborates with Southern Research to develop modified horsepox virus vaccine for Coronavirus infections [4] Updated 03 Mar 2020 |
| 26 Feb 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019-infections (Prevention) in USA (Topical) before February 2020 [4] Updated 03 Mar 2020 |
References
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Tonix Pharmaceuticals Announces Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics.
Media Release -
Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics.
Media Release -
Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Fully Human and Murine Anti-SARS-CoV-2 Monoclonal Antibodies.
Media Release -
Tonix Pharmaceuticals Announces Research Collaboration with Southern Research to Develop a Potential Vaccine to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on Horsepox Virus (TNX-1800).
Media Release -
Tonix Pharmaceuticals and Southern Research Announce Expansion of COVID-19 Vaccine Collaboration.
Media Release -
Tonix Pharmaceuticals Announces FUJIFILM Diosynth Biotechnologies to be Manufacturing Partner for COVID-19 Vaccine Candidate TNX-1800.
Media Release -
Tonix Pharmaceuticals' Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials.
Media Release -
Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-1800 as a Potential Vaccine to Prevent COVID-19.
Media Release -
Tonix Pharmaceuticals Reports Third Quarter 2020 Financial Results and Operational Highlights.
Media Release -
Tonix Pharmaceuticals Enrolls First Patient in COV-LOGIC, an Observational Study to Assess Antibody and T Cell Responses to SARS-CoV-2, the Virus that Causes COVID-19.
Media Release -
Tonix Pharmaceuticals Reports Positive Immune Response Results from COVID-19 Vaccine Candidate TNX-1800, Following Vaccination of Non-Human Primates.
Media Release -
Tonix Pharmaceuticals Reports Positive COVID-19 Vaccine Efficacy Results in Non-Human Primates Vaccinated with TNX-1800 and Challenged with Live SARS-CoV-2.
Media Release -
Investor Presentation: Tonix Pharmaceuticals. Internet-Doc 2020;.
Available from: URL: https://content.equisolve.net/tonixpharma/media/cfe6777f777cbb421861e6b7727ebb85.pdf -
Tonix Pharmaceuticals_10-K_SEC filing_Dec-2021. Internet-Doc 2022;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1430306/000138713122003640/tnxp-10k_123121.htm -
Tonix Pharmaceuticals Reports First Quarter 2021 Financial Results and Operational Highlights.
Media Release -
Tonix Pharmaceuticals Presents Positive Results from Phase 3 RELIEF Study of TNX-102 SL for the Management of Fibromyalgia at the American College of Rheumatology Convergence 2021.
Media Release
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