PARIS & NANTES, France--(BUSINESS WIRE)--Regulatory News:
OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173 ; Mnémo : OSE), an immunotherapy company developing activating or regulating immunotherapies in immuno-oncology, autoimmune diseases and transplantation, today 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.
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 (2), (3).
Effi-7, targeted for the treatment of ulcerative colitis, 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).
Nicolas Poirier, Chief Scientific Officer for OSE Immunotherapeutics, commented: “We are very proud to have been able to present these promising results of a regulatory immunotherapy of the immune system at a renowned congress of immunology. These new data for Effi-7, in preclinical models of ulcerative colitis, confirm the product’s innovative mechanism of action and efficacy in a T-cell mediated inflammation. This immunologic approach has the potential to offer a new therapeutic option to patients suffering from inflammatory bowel autoimmune diseases, as well as chronic diseases in which the efficacy of widely used therapies is limited due to treatment intolerance or frequent therapeutic escape.”
(1) Poster: “IL-7 receptor blockade prevents intestinal human
T cells infiltration by modulation of alpha4-beta7 integrin expression”
(2)
Powell, N. et al. The transcription factor T-bet regulates intestinal
inflammation mediated by interleukin-7 receptor+ innate lymphoid cells.
Immunity 37, 674–684 (2012).
(3) Yamazaki, M. et al.
Mucosal T cells expressing high levels of IL-7 receptor are potential
targets for treatment of chronic colitis. J. Immunol. 171, 1556–1563
(2003).
ABOUT EFFI-7, IL-7 RECEPTOR ANTAGONIST IN REGULATION IMMUNOTHERAPY
Currently in preclinical development phase, Effi-7 is a humanized monoclonal antibody targeting the CD127 receptor, the alpha chain of the Interleukin 7 receptor (IL-7R), and is indicated for long-term control of the pathogenic T cells in the intestines which can prevent inflammatory bowel diseases (i.e. ulcerative colitis). Preliminary results show a pharmacological profile with a dose/effect relationship and a satisfactory safety profile.
ABOUT THE « FEDERATION OF CLINICAL IMMUNOLOGIES SOCIETIES » (FOCIS)
The annual FOCIS meeting highlights the best science in the field of clinical immunology. In addition, the FOCIS meeting is an incubator for developing scientists and practitioners alike to meet with one another and representatives of the relevant biotech and pharmaceutical industry whose combined support is invaluable to the success of the field of clinical immunology.
ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotechnology company specializing in immune regulation with clinical applications in immuno-oncology, autoimmune diseases and transplantation. The company has a balanced portfolio, from R&D to clinical phase 3 registration, with a diversified risk profile. It is composed of advanced immunotherapy products in clinical pivotal phase 3 and in phase 2 with Tedopi® (combined neoepitopes in oncology, developed in advanced lung cancer, NSCLC); and FR104 in phase 1 (a CD28-antagonist immunotherapy – license option Janssen Biotech Inc., a Johnson & Johnson company). The company also has promising products in preclinical phase and potential drug candidates in R&D, targeting new receptors of interest in immuno-oncology, autoimmune and inflammatory diseases, and transplantation. This product portfolio is supported by an innovative technology foundation and know-how in selection and optimization of new generation products acting on new immunological targets, notably a new generation check-point inhibitor targeting suppressive myeloid cells and macrophages associated to tumors (Effi-DEM) and an immunomodulator, interleukin-7 antagonist (Effi-7), developed for autoimmune diseases and transplantation.
Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import.
Although the OSE Immunotherapeutics’ management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance.
This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 8 June 2016 under the number R.15-052, the consolidated financial statements and the management report for the fiscal year 2015, as well as the Merger Document registered with the AMF on 26 April 2016 under number E.16-026, all available on the OSE Immunotherapeutics’ website.
Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.