Sangivamycin - OyaGen/National Institute of Allergy and Infectious Diseases
Alternative Names: OYA-1; Sangivamycin - OyaGen; TNX-3500Latest Information Update: 20 Sep 2023
At a glance
- Originator OyaGen
- Developer National Institute of Allergy and Infectious Diseases; OyaGen
- Class Antivirals; Small molecules
- Mechanism of Action Virus replication inhibitors
-
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; Ebola virus infections
Most Recent Events
Development Overview
Introduction
An intravenous solution of sangivamycin is being developed by OyaGen, in collaboration with National Institute of Allergy and Infectious Diseases, for the treatment of coronavirus (COVID-2019) infections and Ebola virus infections. Sangivamycin is a broad-spectrum antiviral drug and acts against coronaviruses SARS-CoV-2 and MERS-CogV. The drug is a dual target-specific antiviral against filoviruses such as ebola virus. Sangivamycin inhibits the replication of ebola virus and also its close relative. OyaGen plans to develop the drug in a combination therapy for COVID-2019 infections to avoid the emergence of drug-resistant virus. Sangivamycin treatment is expected to serve as a stop-gap treatment. Preclinical development in COVID-19 infections and Ebola virus infections is underway in the US.
Sangivamycin was approved by the US FDA for the treatment of cancer. However, due to lack of efficacy the drug was abandoned.
Company Agreements
In September 2022, Tonix Pharmaceuticals terminated the licensing agreement with OyaGen as no payments were accrued or paid in relation to this agreement. In April 2021, OyaGen and Tonix Pharmaceuticals entered into an exclusive worldwide licensing agreement for the sangivamycin for the treatment of COVID-2019 infections and other viral disorders. Under the terms of the agreement, Tonix received an exclusive license and patents related to sangivamycin and other related compounds. Tonix wil be responsible for further studies to test safety and efficacy of the sangivamycin as necessary to support regulatory approval. [1] [2]
Key Development Milestones
In September 2023, OyaGen announced that it will conduct further in vivo studies recommended by the US FDA for the safety and efficacy of sangivamycin in treating COVID-19 infection in animal model systems as a prerequisite to filing for and IND and conducting phase I clinical studies [3] .
In September 2023, OyaGen announced its intention to initiate a phase I trial for COVID-2019 infection in the US [3] .
In August 2021, Tonix Pharmaceuticals announced its intention to file IND application with the US FDA for COVID-2019 infections [4] .
In November 2021, data from preclinical studies of sangivamycin were released by the company [5] [6] .
In May 2021, OyaGen released preclinical data demonstrating broad-spectrum activity of sangivamycin in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV [7] .
In January 2021, OyaGen released preclinical data for sangivamycin in ebola virus infections [8] .
In March 2020, OyaGen released preclinical data for sangivamycin in COVID-19 infections [9] .
Patent Information
In August 2023, OyaGen has patent protection in US for sangivamcin in treating patients infected with COVID (US1 173 802 5B2) entitled "methods for treating coronavirus infections" [3] . As of December 2021, the company holds rights to an US non-provisional patent application number 16 851 047 and international patent application numbers PCT US2020 028 567 and PCT US2021 016 472, entitled "Methods for treating coronavirus infections" [10]
In April 2023, OyaGen has patent protection in US for sangivamcin in treating patients infected with Ebola (US1 161 775 3B2) entitled "methods of treating and inhibiting ebola virus infection" [3] . As of December 2021, the company has certain patents pending for the use of OYA 1 which include US non-provisional patent application number 16 348 867 and an European patent application number 17 869 003.8A, entitled "Methods of treating and inhibiting Ebola virus infection" [10] .
As of September 2022, Tonix Pharmaceuticals terminated the licensing agreement with OyaGen hence it seems the rights to international patent applications have been transferred back to OyaGen [11] . As of December 2021, Tonix Pharmaceuticals have rights to international patent application numbers PCT US2021 027 352 and PCT US2021 027 354, entitled "Method for treating Arenaviridae infections" and "Method for treating Poxviridae infection" respectively [10] .
As at January 2021, patents have been filed on sangivamycin in the US (PCT US2017 060 207), in Canada (06 384 005 CA1) and in Europe (WO 2018 089 306) for methods of treating and inhibiting Ebola virus infections (OyaGen pipeline, January 2021).
Drug Properties & Chemical Synopsis
- Route of administration IV
- Formulation Injection
- Class Antivirals, Small molecules
- Target Virus replication
- Mechanism of Action Virus replication inhibitors
-
WHO ATC code
J05A-X (Other antivirals)
-
EPhMRA code
J5B9 (Antivirals, others)
- Chemical name 4-amino-7-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrrolo[2,3-d]pyrimidine-5-carboxamide
- Molecular formula C12 H15 N5 O5
- CAS Registry Number 18417-89-5
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Preclinical | USA | IV / Injection | National Institute of Allergy and Infectious Diseases, OyaGen | 16 Mar 2020 |
| Ebola virus infections | - | - | Preclinical | USA | IV / Injection | National Institute of Allergy and Infectious Diseases, OyaGen | 07 Jan 2021 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| OyaGen | Originator | USA |
| OyaGen | Owner | USA |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
Scientific Summary
Pharmacodynamics
Preclinical studies in replicating cell culture demonstrated that OYA1 was more effective compared to the positive-control compound chlorpromazine HCl at inhibiting Coronavirus (COVID-19) infections [9] .
In preclinical studies, sangivamycin inhibited several viruses including ebola, lassa viruses and orthopoxviruses. In vitro studies showed that when sangivamycin is dosed with remdesivir, both compounds are markedly more effective in inhibiting ebola virus replication at much lower doses than is needed with either compound alone. Sangivamycin suppressed viral replication in tissue culture with greater efficacy than remdesivir. Sangivamycin proved equally effective in stopping ebola infectivity when it was added at the time of infection or 24 hours after an infection. When tested in combination with remdesivir, both drugs had additive rather than competitive effect against SARS-CoV-2. Sangivamycin had similar low nanomolar antiviral activity in laboratory-based assays against multiple variants of SARS-CoV-2, including the Delta variant. Preclinical animal safety studies identified safe dose ranges and showed that, sangivamycin was retained in the tissues of the body for several days at comparatively lower concentrations [5] [8] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 18 Sep 2023 | Trial Update | OyaGen plans a phase I trial for COVID-2019 infection in USA [3] Updated 20 Sep 2023 |
| 29 Aug 2023 | Patent Information | OyaGen has patent protection for sangivamycin in the treatment of COVID infections in USA [3] Updated 22 Sep 2023 |
| 04 Apr 2023 | Patent Information | OyaGen has patent protection for sangivamycin in the treatment of Ebola infections in USA [3] Updated 22 Sep 2023 |
| 20 Sep 2022 | Licensing Status | Tonix Pharmaceuticals terminates licensing agreement with OyaGen for sangivamycin [2] Updated 18 Apr 2023 |
| 31 Dec 2021 | Patent Information | Tonix Pharmaceuticals has patents pending for sangivamycin in USA, prior to December 2021 [10] Updated 20 Apr 2022 |
| 22 Nov 2021 | Scientific Update | Updated pharmacodynamics data from preclinical studies in COVID-2019 infections and Ebola virus infections released by OyaGen [5] Updated 30 Nov 2021 |
| 09 Aug 2021 | Regulatory Status | Tonix Pharmaceuticals plans to file IND application for COVID-2019 infections [4] Updated 13 Aug 2021 |
| 09 Aug 2021 | Trial Update | Tonix Pharmaceuticals plans phase I trials for COVID-2019 infections (IV) [4] Updated 13 Aug 2021 |
| 09 Aug 2021 | Trial Update | Tonix Pharmaceuticals plans preclinical for COVID-2019 infections (IV) [4] Updated 13 Aug 2021 |
| 19 Apr 2021 | Licensing Status | Sangivamycin licensed to Tonix pharmaceuticals Holding Corp worldwide for the treatment of COVID-2019 infections [1] Updated 22 Apr 2021 |
| 14 Apr 2021 | Patent Information | OyaGen has patents pending for sangivamycin worldwide [11] Updated 22 Sep 2023 |
| 07 Jan 2021 | Patent Information | Files patent protection for sangivamycin in USA, Canada and Europe (OyaGen pipeline, January 2021) Updated 12 Jan 2021 |
| 07 Jan 2021 | Phase Change - Preclinical | Preclinical trials in Ebola virus infections in USA (IV) [8] Updated 12 Jan 2021 |
| 07 Jan 2021 | Scientific Update | Pharmacodynamics data from preclinical studies in Ebola virus infections released by OyaGen [8] Updated 12 Jan 2021 |
| 16 Mar 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (IV), prior to March 2020 [9] Updated 16 Mar 2020 |
References
-
Tonix Pharmaceuticals Enters into Exclusive Worldwide Licensing Agreement with OyaGen to Develop Antiviral SARS-CoV-2 Inhibitor, TNX-3500, for the Treatment of COVID-19.
Media Release -
SEC filing. Internet-Doc 2023;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1430306/000138713123003377/tnxp-10k_123122.htm -
OyaGen, Inc. announces a new publication for its COVID therapeutic in development and publication of related patents.
Media Release -
Tonix Pharmaceuticals Reports Second Quarter 2021 Financial Results and Operational Highlights.
Media Release -
Tonix Pharmaceuticals Announces Publication of Paper on Antiviral SARS-CoV-2 Inhibitor, TNX-3500, in JCI Insight.
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 -
Tonix Pharmaceuticals Reports First Quarter 2021 Financial Results and Operational Highlights.
Media Release -
Oyagen, Inc. Publishes Study On Its OYA1 As A Highly Effective Experimental Drug Candidate For Treating Infections By The Ebola Virus.
Media Release -
OyaGen, Inc. Announces a Compound in Development with Broad Antiviral Activity Against Coronaviruses, including SARS-CoV-2.
Media Release -
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 -
Method for treating poxviridae infections. Internet-Doc 2023;.
Available from: URL: https://patents.google.com/patent/WO2021211759A1/en?oq=WO2021211759A1
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