OSE Immunotherapeutics is committed to the fight against COVID-19. Its team of immunologists is actively working on the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2.
CoVepiT incorporates 11 neoepitope 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 (neoepitopes) 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 phase of neoepitope vaccine Tedopi® in patients with non-small lung cancer.
In August 2020, positive data from preclinical and human ex vivo studies with CoVepiT have been published online in BioRxiv :
- Data support potential as novel and differentiated COVID-19 vaccine designed against multiple SARS-CoV-2 targets with technology known to induce memory T lymphocytes.
- Studies show that CoVepiT provides tissue-resident memory (Trm) sentinel T cell response with long-term protective immunity in barrier tissues such as the respiratory tract and the lung.
On April 1, 2021, the Belgian Federal Agency for Medicines and Health Products (Agence Fédérale des Médicaments et des Produits de Santé – AFMPS) and the Belgian Ethics Committee approved the Phase 1 trial evaluating CoVepiT on 48 healthy volunteers. This Phase 1 aims at evaluating the safety, reactogenicity and immunogenicity of CoVepiT.
The CoVepiT program is based on a clinically-validated technology now shown to induce tissue-resident memory T lymphocytes (Trm) sentinel response against multiple parts of SARS-CoV-2, suggesting it provides a long-term protective immunity, as opposed to transient protection provided by neutralizing antibodies.
In addition, this vaccine is designed to anticipate ongoing recurrent virus mutation and evolution, further adding to its long-term protective potential.
T-cell epitopes were selected based on the natural immunity observed against the Company’s peptides in convalescent COVID-19 patients.
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.
ABOUT THE 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.
The results from both preclinical and human ex vivo studies build a strong basis for supporting the development of CoVepiT as a novel and differentiated COVID-19 vaccine.
In Phase 1 clinical trial since April 1, 2021, the Company announced on July 1st a voluntary and temporary pause of enrollment and dosing in this study. This pause was decided after receiving a preliminary update by the trial’s principal regarding a limited number of Grade 1 and one Grade 2 adverse events, in particular, persistent nodules around injection points. 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.