COVID-19 therapeutic- CEL-SCI Corporation
Latest Information Update: 04 Dec 2020
At a glance
- Originator CEL-SCI Corporation
- Class Antivirals; Peptides
- 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 Dec 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Injection) before December 2020
- 01 Dec 2020 Immunogenicity data from a preclinical trial in COVID-2019 infections released by CEL-SCI Corporation
- 27 Jul 2020 Preclinical trials in COVID-2019 infections in USA (unspecified route)
Development Overview
Introduction
An immunotherapy directed towards antigens within the NP protein of COVID-19 is being developed by CEL-SCI Corporation for the treatment of coronavirus infection. The therapeutic is being developed using the company's proprietary L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology platform which will use conserved regions of coronavirus proteins to stimulate protective cell mediated cytolytic T cell responses and reduce viral load. L.E.A.P.S.™ generated therapeutics exhibit both antiviral and anti-inflammatory properties. The COVID-19 peptide is believed to not only arrest the progression of the virus but also prevent tissue damage from inflammation resulting from lung infection by the virus. Preclinical development is ongoing in the US.
Company Agreements
In March 2020, CEL-SCI Corporation entered into a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology for the development of LEAPS COVID-19 immunotherapy. The collaboration will commence with pre-clinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic. [1]
Key Development Milestones
In December 2020, CEL-SCI Corporation released immunogenicity data for preclinical trial conducted using LEAPS COVID 19 peptide that showed clear survival benefit as a treatment for COVID-2019 infections [2] .
In July 2020, CEL-SCI Corporation released immunogenicity data for preclinical trial conducted using LEAPS COVID 19 conjugate [3] .
Patent Information
L.E.A.P.S.™ is protected by patents in the United States issued in February 2006, April 2007, August 2007, January 2019 and March 2019. The LEAPS patents, which expire in 2021, 2022, 2021 and three in 2032, respectively, include overlapping claims, with composition of both matter (new chemical entity), process and methods-of-use, to maximize and extend the coverage in their current format [4] [5] [6] .
In October 2017, a patent was issued in Europe for L.E.A.P.S.™ , which expires in 2029 [4] .
CEL-SCI Corporation has four patent applications pending in the United States and one in Europe for L.E.A.P.S.™, which, if issued, would extend protection through 2034, subject to any potential patent term extensions [4] .
Drug Properties & Chemical Synopsis
- Route of administration Injection
- Formulation unspecified
- Class Antivirals, Peptides
- Mechanism of Action Immunostimulants
-
WHO ATC code
J05A-X (Other antivirals)
-
EPhMRA code
J5B9 (Antivirals, others)
Table of Contents
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Preclinical | USA | Injection / unspecified | CEL-SCI Corporation | 27 Jul 2020 |
| COVID 2019 infections | - | Prevention | Preclinical | USA | Injection / unspecified | CEL-SCI Corporation | 01 Dec 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| CEL-SCI Corporation | Originator | USA |
| CEL-SCI Corporation | Owner | USA |
| University of Georgia | Collaborator | USA |
Scientific Summary
Immunogenicity
Summary
In preclinical studies, treatment with LEAPS COVID 19 conjugates after only one injection showed enhanced antibody responses against a non-mutating region of the virus that causes COVID 19 [3] .
In preclinical studies, treatment with LEAPS COVID-19 peptides after only one injection showed clear survival benefit as a treatment for COVID-2019 infections. Of the LEAPS treated mice, 40% were alive, recovering and regained lost weight, attaining > 90% of their starting weight, by the study’s end. In contrast, mice in the two control groups lost 20% or more of their body weight by day 8 and all of them died between day 5 and day 8 post challenge. In addition, another animal study using LEAPS COVID-19 to prevent disease resulted in similar findings to the therapeutically treated animals, but with a slightly lower level of statistical significance [2] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 01 Dec 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (Injection) before December 2020 [2] Updated 04 Dec 2020 |
| 01 Dec 2020 | Scientific Update | Immunogenicity data from a preclinical trial in COVID-2019 infections released by CEL-SCI Corporation [2] Updated 04 Dec 2020 |
| 27 Jul 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (unspecified route) [3] Updated 28 Jul 2020 |
| 27 Jul 2020 | Scientific Update | Immunogenicity data from preclinical trial in COVID-2019 infections released by CEL-SCI Corporation [3] Updated 28 Jul 2020 |
| 26 Mar 2020 | Licensing Status | CEL-SCI Corporation entered into a collaboration agreement with the University of for the development of Coronavirus vaccine [1] Updated 31 Mar 2020 |
| 09 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (unspecified route) Updated 20 Mar 2020 |
| 23 Dec 2019 | Patent Information | CEL-SCI has patents pending for LEAPS technology in USA and European Union [4] Updated 20 Mar 2020 |
| 30 Jan 2018 | Patent Information | CEL-SCI has patent protection for LEAPS technology in USA and in European Union [5] Updated 20 Mar 2020 |
References
-
CEL-SCI to Develop LEAPS COVID-19 Immunotherapy in Collaboration with University of Georgia Center for Vaccines and Immunology.
Media Release -
CEL-SCIs LEAPS Peptides Demonstrate Clear Survival Benefit as a Treatment for COVID-19 in Preclinical Studies.
Media Release -
CEL-SCI Announces Early Results with COVID 19 LEAPS Vaccine/Treatment.
Media Release -
CEL SCI Corporation SEC filing, December 2019. Internet-Doc 2020;.
Available from: URL: http://filings.irdirect.net/data/725363/000165495419014164/cvm_10kn.pdf -
U.S. PATENT OFFICE ALLOWS NEW CEL-SCI PATENTS FOR LEAPS VACCINE PLATFORM TECHNOLOGY.
Media Release -
U.S. Patent Office Allows New CEL-SCI Patent For LEAPS Vaccine Platform Technology.
Media Release
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