Session: SUN 839-872-Diabetes & Obesity Management
Poster Board SUN-871
Authors: Claudia Cavelti-Weder, Katharina Timper (presenting author), Eleonora Seelig, Cornelia Keller, Martin Osranek, Patrik Maurer, Gunther Spohn, Jörg Willers, Martin Bachmann, Marc Y. Donath
Interleukin-1beta (IL-1beta) is a key cytokine involved in inflammatory illnesses including type 2 diabetes. We developed and evaluated the safety and induction of antibody response (ELISA and neutralizing antibody assay) of a novel vaccine against IL-1beta (CYT013-IL1bQb) in animal models and in a randomized, double-blinded, placebo-controlled Phase I trial in patients with type 2 diabetes.
Murine and simian preclinical trials showed prompt induction of IL-1beta antibodies upon vaccination. In the clinical study involving 48 type 2 diabetic patients, 6 staggered cohorts of 8 patients each (6 patients IL1bQb, 2 Placebo) were treated with stepwise increasing doses and number of injections at predetermined time points. CYT013-IL1bQb was safe and well-tolerated. IL-1beta-specific antibody responses could be observed in most patients after immunization with the vaccine. IL-1beta-neutralizing antibodies indicating the clinical relevance of the immune response, however, were only evident in the highest dose group. There was preliminary indication of in vivo activity in patients with neutralizing antibodies as apparent from decreased HbA1c and glucose levels. In summary, IL-1beta-vaccine may represent a novel treatment modality for the IL-1beta-dependent diseases such as type 2 diabetes.
Disclosure: PM: Employee, CYTOS Biotechnology AG. GS: Employee, CYTOS Biotechnology AG. JW: Employee, CYTOS Biotechnology AG. MB: Employee, CYTOS Biotechnology AG. MYD: Coinvestigator, CYTOS Biotechnology AG. Nothing to Disclose: CC, KT, ES, CK, MO
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