Neovacs to expand clinical testing of its TNF-alpha Kinoid lead product candidate
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Neovacs, a biotechnology company developing proprietary immunotherapeutics for autoimmune and chronic diseases, announced that subject to regulatory consent, it plans to initiate a Phase II study of its TNF-alpha Kinoid later this year in rheumatoid arthritis patients who have failed treatment with at least one TNF-alpha inhibitor. The decision to proceed with the trial was based on an initial review of encouraging data from the company's Phase I/II study in Crohn’s disease.
The proposed trial will initially test two dose levels of the TNF-Kinoid, with the option of expanding recruitment and extending follow-up in one dose group on the basis of serological and clinical responses. The multicentre, Europe-wide trial received significant public funding from OSEO, the French state innovation agency.
The ongoing Phase I/II dose-escalation study (taking place in South Africa and Switzerland) is recruiting between 12 and 18 patients with active Crohn’s Disease and is intended to evaluate the Kinoid's safety and immunogenicity. In the context of active immunotherapy, safety parameters include (i) the absence of adverse reactions and (ii) serological measurements of the nature of the immune response, such as the kinetics of the antibody response and whether the cellular immune system (and specifically T cell memory) is stimulated. The trial is also tracking a clinical endpoint for disease status - the Crohn’s Disease Activity Index.
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