NANTES, France--(BUSINESS WIRE)--Regulatory News:
OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE) today announced authorization by Federal Agency for Medicines and Health Products (FAMH) and Belgian Ethics Committee to initiate a Phase 1 clinical trial of OSE-127, a monoclonal antibody targeting the IL-7 Receptor (IL-7R) with a novel mechanism of action(1).
The first-in-human dose-escalation Phase 1 clinical study aims to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127. A total of 63 healthy volunteers will be enrolled in this randomized, double-blind, placebo-controlled study.
Alexis Peyroles, CEO of OSE Immunotherapeutics, said: “Initiating this Phase 1 study represents a leap forward for OSE-127. On the heels of publishing the unique mechanism of action of OSE-127 in Nature Communications(1), we believe even more strongly that this asset has significant potential therapeutic value for treatment of autoimmune diseases and chronic inflammation.”
Specifically targeting IL-7R expression, which has previously been shown to be predictive for non-response to inflammatory bowel disease treatments, and by enhancing regulatory T lymphocytes in the mucosa, OSE-127 offers a differentiated mechanistic profile in debilitating autoimmune conditions, such as intestinal bowel diseases.
OSE-127 is being developed under an option license agreement with Servier* up to the completion of a Phase 2 clinical trial, planned in ulcerative colitis, a bowel autoimmune disease, and in parallel in Sjögren’s syndrome.
*Servier is an independent international pharmaceutical company governed by a foundation with Headquarters based in France.
ABOUT OSE-127
OSE-127 is a monoclonal immunomodulatory
antibody targeting the CD127 receptor, the alpha chain of the
interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect
on effector T lymphocytes. Interleukin-7 is a cytokine which
specifically regulates the tissue migration of human effector T
lymphocytes, especially in the gut. The blockage of IL-7R prevents the
migration of pathogenic T lymphocytes while preserving regulator T
lymphocytes (2,3) which have a positive impact in autoimmune
diseases.
OSE Immunotherapeutics has signed a license option agreement with Servier in December 2016 for the development and commercialization of OSE-127.
(1) Cf.
Press release of October 26, 2018: Belarif, L. et al.IL-7 receptor
blockade blunts antigen-specific memory T cell responses and chronic
inflammation. Nature communications, 26 October 2018
(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 OSE Immunotherapeutics
OSE Immunotherapeutics is a
clinical-stage biotechnology company focused on developing and
partnering therapies to control the immune system for immuno-oncology
and autoimmmune diseases. The company has a diversified first-in-class
clinical portfolio consisting of several scientific and technological
platforms including neoepitopes and agonist or antagonist monoclonal
antibodies, all ideally positioned to fight cancer and autoimmune
diseases. Our most advanced asset, Tedopi®, is a proprietary
combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is
currently in Phase 3 development in non-small cell lung cancer (NSCLC)
after checkpoint inhibitor failure (anti PD-1 and anti PD-L1). In April
2018, Boehringer Ingelheim and OSE signed a global license and
collaboration agreement to develop checkpoint inhibitor OSE-172
(anti-SIRPa monoclonal antibody) in multiple cancer indications. In July
2016, Janssen Biotech exercised a licensing option to continue clinical
development of FR104 (an anti-CD28 mAb) in auto-immune diseases after
positive Phase 1 results; termination of licence agreement effective
Dec. 31, 2018 due to strategic portfolio prioritization and OSE regained
all worldwide rights on this asset. In 2016, Servier signed a two-step
license option to develop OSE-127 (monoclonal antibody targeting the
CD127 receptor, the alpha chain of the interleukin-7 receptor) up to the
completion of a Phase 2 clinical trial planned in autoimmune bowel
diseases; in parallel, Servier plans a development in the Sjögren
syndrome.
Click and follow us on Twitter and Linkedln
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 26 April 2018, including the
annual financial report for the fiscal year 2017, 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.