Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused mass mortality in the last 3 months that necessitates urgent development of new therapeutical agents. So far there is no effective anti-viral drug to reduce viral load that has critical importance to prevent progress into severe viral pneumonia and systemic hyper inflammation state. This project is to offer a biologic agent based on T cell derived exosomes. This is a novel approach using our proprietary protocols for drug development. This clinical trial is to test the safety and efficacy of this new agent following targeted delivery by metered dose inhaler. The project have received proper approvals from the Turkish Ministry of Health and Erciyes University, Kayseri Turkey. Turk-Patent Application Number: PCT/TR2020/050302

Start Date01 May 2020

Sponsor / Collaborator

Tc Erciyes University

100 Clinical Results associated with COVID-19 Specific T Cell derived exosomes(Tc Erciyes University)

100 Translational Medicine associated with COVID-19 Specific T Cell derived exosomes(Tc Erciyes University)

100 Patents (Medical) associated with COVID-19 Specific T Cell derived exosomes(Tc Erciyes University)

Literatures (Medical) associated with COVID-19 Specific T Cell derived exosomes(Tc Erciyes University)

Nature CommunicationsQ1 · CROSS-FIELD

Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency

Q1 · CROSS-FIELD

ArticleOA

Author: Fischer, Imma ; Peuker, Caroline Anna ; Klimovich, Boris ; Heitmann, Jonas S ; Denk, Monika ; Rammensee, Hans-Georg ; Jaeger, Simon U ; Lutz, Martina ; Clar, Kim L ; Habringer, Stefan ; Bauer, Jens ; Jäger, Elke ; Wacker, Marcel ; Rittig, Susanne M ; Löffler, Markus W ; Holzmayer, Samuel ; Habibzada, Timorshah ; Salih, Helmut R ; Hörber, Sebastian ; Oezbek, Melek T ; Tegeler, Christian M ; Marconato, Maddalena ; Peter, Andreas ; Scheid, Jonas ; Hoenisch Gravel, Naomi ; Märklin, Melanie ; Richter, Marion ; Henrich, Annika ; Schroeder, Sarah M ; Tandler, Claudia ; Nelde, Annika ; Maringer, Yacine ; Goetze, Thorsten O ; Walz, Juliane S ; Meisner, Christoph ; Wiesmüller, Karl-Heinz ; Rieth, Jonas

AbstractT-cell immunity is central for control of COVID-19, particularly in patients incapable of mounting antibody responses. CoVac-1 is a peptide-based T-cell activator composed of SARS-CoV-2 epitopes with documented favorable safety profile and efficacy in terms of SARS-CoV-2-specific T-cell response. We here report a Phase I/II open-label trial (NCT04954469) in 54 patients with congenital or acquired B-cell deficiency receiving one subcutaneous CoVac-1 dose. Immunogenicity in terms of CoVac-1-induced T-cell responses and safety are the primary and secondary endpoints, respectively. No serious or grade 4 CoVac-1-related adverse events have been observed. Expected local granuloma formation has been observed in 94% of study subjects, whereas systemic reactogenicity has been mild or absent. SARS-CoV-2-specific T-cell responses have been induced in 86% of patients and are directed to multiple CoVac-1 peptides, not affected by any current Omicron variants and mediated by multifunctional T-helper 1 CD4+ T cells. CoVac-1-induced T-cell responses have exceeded those directed to the spike protein after mRNA-based vaccination of B-cell deficient patients and immunocompetent COVID-19 convalescents with and without seroconversion. Overall, our data show that CoVac-1 induces broad and potent T-cell responses in patients with B-cell/antibody deficiency with a favorable safety profile, which warrants advancement to pivotal Phase III safety and efficacy evaluation. ClinicalTrials.gov identifier NCT04954469.

100 Deals associated with COVID-19 Specific T Cell derived exosomes(Tc Erciyes University)

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 1	-	Erciyes University	-

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