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Author: Jaeger, Simon U ; Tegeler, Christian M ; Oezbek, Melek Tutku ; Schroeder, Sarah M ; Heitmann, Jonas S ; Denk, Monika ; Bitzer, Michael ; Fischer, Imma ; Michel, Tanja M ; Marconato, Maddalena ; Salih, Helmut R ; Richter, Marion ; Schindler, Michael ; Meisner, Christoph ; Tandler, Claudia ; Rammensee, Hans-Georg ; Walz, Juliane S ; Maringer, Yacine ; Wiesmüller, Karl-Heinz ; Schneiderhan-Marra, Nicole ; Ruetalo, Natalia

OBJECTIVEST cell immunity is key for the control of viral infections including SARS-CoV-2, in particular with regard to immune memory and protection against arising genetic variants.METHODSWe recently evaluated a peptide-based SARS-CoV-2 T cell activator termed CoVac-1 in a first-in-human trial in healthy adults. Here, we report on long-term safety and efficacy data of CoVac-1 until month 12.RESULTSCoVac-1 is well tolerated without long-term immune-related side effects and induces long-lasting anti-viral T cell responses in 100% of study participants, with potent expandability of clusters of differentiation (CD4⁺) and CD8⁺ T cells targeting multiple different CoVac-1 T cell epitopes. T cell responses were associated with stronger injection site reaction. Beyond induction of T cell immunity, 89% of subjects developed CoVac-1-specific immunoglobulin G antibodies which associated with the intensity of the T cell response, indicating that CoVac-1-specific CD4⁺ T cells support the induction of B-cell responses. Vaccination with approved COVID-19 vaccines boosted CoVac-1-specific T cell responses. Overall, a low SARS-CoV-2 infection rate (8.3%) was observed.CONCLUSIONTogether, a single application of CoVac-1 elicits long-lived and broad SARS-CoV-2-specific T cell immunity, which further supports the current evaluation of our T cell activator in patients with congenital or acquired B-cell defects.

01 Dec 2019·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

A new synthetic toll-like receptor 1/2 ligand is an efficient adjuvant for peptide vaccination in a human volunteer

Q2 · MEDICINE

ArticleOA

Author: Rusch, Elisa ; Di Marco, Moreno ; Chandran, P Anoop ; Haen, Sebastian P ; Walz, Juliane S ; Klein, Reinhild ; Wiesmüller, Karl-Heinz ; Metzler, Gisela ; la Fougère, Christian ; Tunger, Antje ; Artzner, Kerstin ; Laske, Karoline ; Müller, Luise ; Pichler, Bernd J ; Jakobi, Meike ; Bödder, Johanna ; Zelba, Henning ; Weber, Alexander N R ; Schmitz, Marc ; Schwenck, Johannes ; Gloria, Yamel Cardona ; Gouttefangeas, Cécile ; Schertel, Jill-Marie ; Forchhammer, Stephan ; Weide, Benjamin ; Stevanović, Stefan ; Kießler, Maximilian ; Bauer, Jürgen ; Schneiderhan-Marra, Nicole ; Rammensee, Hans-Georg ; Schuster, Heiko ; Wehner, Rebekka ; Schippert, Wilfried ; Kneilling, Manfred ; Löffler, Markus W ; Backert, Linus ; Kowalewski, Daniel J

BACKGROUNDWe previously showed that the bacterial lipopeptide Pam₃Cys-Ser-Ser, meanwhile established as a toll-like receptor (TLR) 1/2 ligand, acts as a strong adjuvant for the induction of virus specific CD8⁺ T cells in mice, when covalently coupled to a synthetic peptide.CASE PRESENTATIONWe now designed a new water-soluble synthetic Pam₃Cys-derivative, named XS15 and characterized it in vitro by a TLR2 NF-κB luciferase reporter assay. Further, the capacity of XS15 to activate immune cells and stimulate peptide-specific CD8⁺ T and NK cells by 6-sulfo LacNAc⁺ monocytes was assessed by flow cytometry as well as cytokine induction using immunoassays. The induction of a functional immune response after vaccination of a volunteer with viral peptides was assessed by ELISpot assay and flow cytometry in peripheral blood cells and infiltrating cells at the vaccination site, as well as by immunohistochemistry and imaging. XS15 induced strong ex vivo CD8⁺ and T_H1 CD4⁺ responses in a human volunteer upon a single injection of XS15 mixed to uncoupled peptides in a water-in-oil emulsion (Montanide™ ISA51 VG). A granuloma formed locally at the injection site containing highly activated functional CD4⁺ and CD8⁺ effector memory T cells. The total number of vaccine peptide-specific functional T cells was experimentally assessed and estimated to be 3.0 × 10⁵ in the granuloma and 20.5 × 10⁶ in peripheral blood.CONCLUSIONThus, in one volunteer we show a granuloma forming by peptides combined with an efficient adjuvant in a water-in-oil-emulsion, inducing antigen specific T cells detectable in circulation and at the vaccination site, after one single vaccination only. The ex vivo T cell responses in peripheral blood were detectable for more than one year and could be strongly boosted by a second vaccination. Hence, XS15 is a promising adjuvant candidate for peptide vaccination, in particular for tumor peptide vaccines in a personalized setting.

03 Mar 2019·Neurology Research International

Prominent T-Cell Responses against the Acetylcholine Receptor ε Subunit in Myasthenia Gravis

Article

Author: Hartung, Hans-Peter ; Neuhaus, Oliver ; Wiesmüller, Karl-Heinz ; Wiendl, Heinz

The human acetylcholine receptor (AChR) is well characterized as the target antigen in myasthenia gravis (MG). Pathogenic antibody responses against the AChR alpha-chain have been investigated extensively and are of diagnostic and prognostic value. However, less is known on the pathogenetic relevance of T-cell responses against epitopes of the different AChR chains (alpha, epsilon, gamma). Using an enzyme-linked immunospot (ELISPOT) assay we measured T-cell responses against recombinant fragments and synthetic peptides of the α and the ε subunits of the human AChR in MG patients (n=15) and in healthy donors (HD; n=9). In MG, highest T-cell responses were noted against recombinantly expressed Epsilon 1-221. Among the synthetic peptides Epsilon 201-215 showed the most prominent T-cell response and represented the peptide with the most remarkable difference between MG and HD. Taken together, prominent T-cell responses against the ε subunit of the human AChR indicate an important role in the pathogenesis of MG.

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Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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