Clinical Trials

Date: 2017-06-15

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the 2017 Federation of Clinical Immunology Societies

Company: OSE Immunotherapeutics (France)

Product: OSE-127 (Effi-7)

Action mechanism:

• monoclonal antibody. Effi-7 is a monoclonal immunodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that blocks both the IL-7 and the internalization of the receptor. It therefore induces a powerful antagonist effect for better long-term control of the pathogenic T lymphocytes. The strategy of blocking the IL-7 is different from conventional methods, as well as the latest anti-inflammatory drugs used in clinic, and has demonstrated efficacy in restoring the impaired immune balance in autoimmune diseases of the bowel in several clinical models.
• Effi-7 is being developed as part of the consortium EFFIMab, led by OSE Immunotherapeutics. The Effi-7 project is co-financed by Bpifrance in the amount of € 9.1 million (for a total amount of €20 million).
• OSE Immunotherapeutics has signed a license option agreement with Servier in December 2016 for the development and commercialization of OSE-127.

Disease: ulcerative colitis

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Country:

Trial details:

Latest news:

• • On June 15, 2017, OSE Immunotherapeutics presented new data for OSE-127 (Effi-7), an antagonist of the interleukin-7 receptor (IL-7R), at the 2017 Federation of Clinical Immunology Societies held in Chicago from June 14 to 17. The communication entitled “IL-7 pathway controls human T cell homing to the gut and culminates in inflammatory bowel disease mucosa” shows efficacy results for OSE-127 in various preclinical acute or chronic colitis models and ex vivo human biopsies. In preclinical humanized models reconstituted with human T lymphocytes, OSE-127 significantly blocked pathological homing of human T lymphocytes to the inflamed colon thereby preventing destruction of gut mucosa by the T lymphocytes.
• In a separate translational study conducted in human in collaboration with Professor Thomas McDonald (Blizard Institute, Barts and the London School of Medicine), OSE-127 significantly reduced production of gamma interferon expressed by proinflammatory mucosal T lymphocytes ex vivo in colon biopsies from patients with inflammatory bowel disease. Increased expression of IL-7R, IL-7 and genes involved in the IL-7R signalling pathway was observed in the patients’ inflammatory colon biopsies and correlates with a lack of response to current immunosuppressive treatments.
• The expression of the product’s target (IL-7R) in human tissues in case of therapeutic escape represents a major clinical interest for OSE-127, with potential identification of responder patients.
• • On June 27, 2016, OSE Immunotherapeutics announced the presentation of preclinical efficacy results for Effi-7, an antagonist of the interleukin 7 (IL-7) receptor in regulation immunotherapy, at the annual international congress of immunology, « Federation of Clinical Immunology Societies, » held in Boston from June 21 to June 25, 2016. The preclinical results presented (1) showed efficacy of Effi-7, an antagonist of the IL-7 receptor, in ulcerative colitis (UC) models, an autoimmune inflammatory bowel disease of the colon. Efficacy was observed in parallel with an innovative mechanism of action of Effi-7 in the prevention of the infiltration of human T lymphocytes, responsible for the inflammatory damage to the colon mucosa.

Is general: Yes