CoVepiT

OSE Immunotherapeutics is committed to the fight against COVID-19. Our team of immunologists is actively working on the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2.

OSE Immunotherapeutics is committed to the fight against COVID-19. Our team of immunologists is actively working on the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2.

CoVepiT incorporates 11 neo-epitope targets chosen following bioinformatic analysis of more than 167 000 different SARS-CoV-2 sequences collected globally to ensure high stability of the chosen targets and potential to cover all initial and novel SARS-CoV-2 strains and variants.

 

  • Long-lasting immune response
    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 such as the respiratory tract and the lung.
  • Optimized peptides to increase immune response
    The vaccine incorporates optimized peptide fragments (neo-epitopes) improved using artificial intelligence algorithms to increase immune response and induce strong memory T cell responses.
  • Broad targeting ready for virus evolution
    Selection and generation of SARS-CoV-2 multi-target peptide vaccine (targeting Spike, M, N, and several non-structural proteins), covered for heterogeneity and already recurrent mutation, observed in up to 46,000 SARS-CoV-2 sequences isolated worldwide and for future virus evolution.
  • Clinically validated technology
    CoVepiT is generated using OSE’s proprietary Memopi® technology which has been validated for both safety and efficacy through the step-1 of Phase 3 clinical trial of neo-epitope vaccine Tedopi® in patients with non-small lung cancer.

ABOUT CoVepiT CLINICAL PROGRAM

A human ex vivo 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 main objective of the study was achieved: the identification of T memory immuno-dominant epitopes after infection with COVID-19.

Based on the results from preclinical and human ex vivo studies, OSE initiated in April 2021 a  Phase 1 clinical trial to evaluate the safety, reactogenicity and immunogenicity of CoVepiT in healthy adult volunteers.

In July, the Company voluntarily and temporarily suspended the recruitment and administration of CoVepiT in the Phase 1 clinical trial as a precaution due to a limited number of adverse reactions (nodule-like indurations at the injection site) grade 1 and a grade 2 adverse reaction in one participant. Since then, the data have been analyzed regularly with the Independent Safety Monitoring Committee in charge of evaluating the safety of the trial and the Ghent (Belgium) investigation center.

The indurations were resolved within a few weeks for most of the participants (without systemic reaction, without fever, nor inflammation, without local ulceration) and the follow-up continues to show a good safety profile. This profile, with frequent indurations, is close to that of vaccines inducing T cell responses (1;2;3) and is regularly linked to this T cell mechanism of action.

A positive analysis of the first data of CoVepiT has shown in particular positive interim immunological results on T cell response obtained in 100% of the treated population, with in parallel a resolution of local indurations observed during vaccination.

Results on the 6-month long-term memory T response, expected in the first quarter of 2022, will be a key element in further clinical development.

Press release November 30, 2021

(1) Pleguezuelos et al.  2020

(2) Rodo et al. PLoS  Pathog 2019

(3) Heitmann, J. S. et al. Nature 2021 

 

ClinicalTrials.gov : NCT04885361

To receive OSE Immunotherapeutics’ latest news