CoVepiT COVID-19 Vaccine Description
CoVepiT is a prophylactic vaccine candidate against COVID-19 based on optimized peptides selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2 in barrier tissues, the respiratory tract, and the lung.
The OSE Immunotherapeutics vaccine candidate incorporates optimized peptide fragments (neoepitopes) improved using artificial intelligence algorithms to increase immune response and induce strong memory T cell responses.
CoVepiT incorporates 11 optimized neoepitope targets chosen following bioinformatics analysis of more than 167,000 different SARS-CoV-2 sequences collected globally to ensure high stability of the selected targets and the potential to cover all initial and novel SARS-CoV-2 strains and variants.
The oral presentation given by Dr. Nicolas Poirier at the virtual 2020 Immunotherapy Congress, titled “CoVepiT: Multiple CD8 T-cell epitopes second-generation SARS-CoV-2 vaccine, long-term, lasting tissue-resident memory T cells,” is available at the Festival of Biologics. Furthermore, this vaccine candidate is also designed to anticipate ongoing recurrent virus mutation and evolution, further adding to its long-term protective potential.
Generated using the OSE’s Memopi vaccinal technology, which has already shown good tolerance and efficacy in a large number of cancer patients, these data build a strong basis to pursue the development of this 2nd generation of SARS-CoV-2 vaccine focused on memory CD8 T cell technology.
Nantes, France-based OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform are focused on three areas: T-cell-based vaccination, ImmunoOncology (focus on myeloid targets), Auto-immunity & Inflammation.
CoVepiT COVID-19 Vaccine Indication
CoVepiT COVID-19 Vaccine candidate is indicated to respond to multiple parts of SARS-CoV-2, suggesting it will provide long-term protective immunity instead of transient protection provided by neutralizing antibodies.
CoVepiT is a prophylactic vaccine against COVID-19 based on optimized peptides selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2 in barrier tissues, respiratory tract, and the lung. The vaccine incorporates optimized peptide fragments (neoepitopes) improved using artificial intelligence algorithms to increase immune response and induce strong memory T cell responses.
CoVepiT COVID-19 Vaccine News
July 19, 2021 - OSE Immunotherapeutics notified the Belgian Health Authorities that the Company is voluntarily pausing its Phase 1 clinical study of CoVepiT in healthy volunteers. This pause was decided after receiving a preliminary update by the trial’s principal investigator at the Center for Vaccinology, Ghent University, regarding a limited number of Grade 1 and one Grade 2 adverse events, in particular, persistent nodules around injection points (subcutaneous, with no pain, no inflammation, no fever, no impact on everyday life and without any systemic symptoms). Out of an abundance of caution and in agreement with the independent Safety Monitoring Committee (SMC), the Company has decided to voluntarily pause dosing in its ongoing clinical study and assess the evolution of these nodules before determining the best way forward for this product and its target population. The Company will carefully review all available data to determine the future clinical development strategy of CoVepiT.
June 30, 2021 - OSE Immunotherapeutics and Cenexi, a French contract development and manufacturing organization, today announced the signature of an agreement whereby Cenexi will manufacture clinical batches of CoVepiT, OSE Immunotherapeutics' vaccine candidate against COVID-19 currently in Phase 1 clinical trial, which will be used in the product’s development phases.
May 26, 2021 - OSE Immunotherapeutics announced that the first healthy volunteer had been enrolled and dosed in the Phase 1 clinical trial evaluating its COVID-19 vaccine, named CoVepiT. This Phase 1 clinical trial evaluates the safety, reactogenicity, and immunogenicity of a two-dose regimen of CoVepiT in 48 healthy adult volunteers, previously vaccinated or not, by an authorized COVID19 vaccine.
May 18, 2021 - OSE Immunotherapeutics announced it had obtained public funding of €10.7 million under the “Capacity Building” call for projects, operated on behalf of the French government by Bpifrance to support further development of its program on CoVepiT, its multi-variant vaccine against COVID-19, currently in Phase 1 clinical trial.
April 1, 2021 - OSE Immunotherapeutics announced that the Belgian Federal Agency for Medicines and Health Products and the Belgian Ethics Committee approved the Phase 1 trial evaluating its COVID-19 vaccine CoVepiT on 48 healthy volunteers. First subjects are expected to be enrolled shortly.
March 26, 2021 - OSE Immunotherapeutics reported its consolidated annual financial results for 2020. In addition, they provided an update on key achievements and the Company’s outlook for 2021 for its immunotherapies in T-cell vaccines immuno-oncology, auto-immunity, and inflammation.
February 15, 2021 - OSE Immunotherapeutics announced that the Company had signed a loan agreement of up to €25 million with the European Investment Bank (EIB). Alexis Peyroles, CEO of OSE Immunotherapeutics, comments: “We are very grateful for EIB’s support, a major financial European institution, as the Company is at an inflection point of its growth. The first €10 million tranche allows OSE to extend its financial visibility to Q2 2022. In addition, this new flexible funding tool will help expand and accelerate the development of our clinical-stage portfolio and explore new therapeutic indications with a strong medical need, reinforcing OSE’s status as a key global player in immunotherapy.”
January 28, 2021 - OSE Immunotherapeutics Expands its Collaboration with MAbSilico to Use Artificial Intelligence to Accelerate Drug Development of Novel Antibody Therapeutics. "A great example is the collaboration between MAbSilico and OSE for CoVepiT, OSE's prophylactic multi-target vaccine against COVID-19. MAbSilico peptide modeling identified vaccine target epitopes in only two weeks, helping OSE move quickly into preclinical and human ex vivo studies in August 2020," stated Vincent Puard, Chief Executive Officer of MAbSilico.
December 18, 2020 - OSE Immunotherapeutics announced that the Company had obtained funding of €5.2 million under the PSPC-COVID call for projects, operated on behalf of the French government by Bpifrance as part of the Programme d’investissements d’avenir and led by the Secrétariat général pour l’investissement, to support its development program on CoVepiT, its second-generation multi-target vaccine against COVID-19.
November 5, 2020 - OSE Immunotherapeutics announced the successful completion of its human ex vivo study with CoVepiT, a prophylactic vaccine based on optimized epitopes selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19. In parallel, OSE Immunotherapeutics gave an overview of the development of this multi-target vaccine at the World Immunotherapy Congress, or Festival of Biologics, held virtually November 2-6, 2020. This is the first presentation on a second-generation memory T cell COVID-19 vaccine at a scientific congress.
August 17, 2020 - OSE Immunotherapeutics announced the online publication in BioRxiv of positive data from preclinical and human ex vivo studies with CoVepiT, its prophylactic vaccine program based on optimized peptides selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2, the virus that causes COVID-19, in barrier tissues such as the respiratory tract and the lung.
August 14, 2020 - Tissue-resident memory CD8 T-cell responses elicited by a single injection of a multi-target COVID-19 vaccine. Data support potential as a novel and differentiated COVID-19 vaccine designed against multiple SARS-CoV-2 targets with technology known to induce memory T lymphocytes.
CoVepiT COVID-19 Vaccine Clinical Trial
The CoVepiT development program will be conducted within a consortium led by OSE Immunotherapeutics, in partnership with the teams of Prof. Eric Tartour, Head of the biological immunology department at the European Hospital Georges-Pompidou-APHP and Professor at the University of Paris, in charge of immune-monitoring and with the teams of Prof. Odile Launay, Professor of infectious and tropical diseases at University of Paris and Coordinator of the Clinical Investigation.
As of April 1, 2021, the Belgian Federal Agency for Medicines and Health Products and the Belgian Ethics Committee approved the Phase 1 trial evaluating its COVID-19 vaccine, named CoVepiT, on 48 healthy volunteers. First subjects are expected to be enrolled shortly.
A clinical study, named CoVepiT 1, was conducted in 120 convalescent COVID-19 subjects versus unexposed subjects. It aimed at assessing the memory T cell immune response at a distance from a resolving infection with SARS-CoV-2 adults. The study's primary objective was to identify T memory immuno-dominant epitopes after infection with COVID-19.