NANTES, France--(BUSINESS WIRE)--Regulatory News:
OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE), today announced the publication of data on OSE -127, its full-antagonist monoclonal antibody targeting the interleukin-7 receptor (IL-7R), in the prestigious Journal of Clinical Investigation (JCI). The article reports on research led by the OSE Immunotherapeutics team, in collaboration with multiple international expert partners, that further supports the product’s potential for the treatment of chronic inflammatory bowel diseases.
The article, entitled “IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease”, concluded that:
- In patients with active mucosal lesions, the overexpression of IL-7R, the target of OSE-127, is significantly increased and is predictive for non-response to anti-TNFα treatment. Moreover, this non-response is strongly correlated to a mucosal defect in regulatory T-lymphocytes.
- 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.
- 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.
“These findings confirm a novel and differentiated mechanism of action of full-antagonist of IL-7R OSE-127. They support the potential of this compound to be a relevant therapy in chronic inflammatory bowel diseases where there is a high unmet medical need. OSE-127 is currently being evaluated in a Phase 1 clinical trial and we look forward to further exploring the product’s potential through our ongoing partnership with Servier1,” commented Nicolas Poirier, chief scientific officer of OSE Immunotherapeutics. “We would like to warmly thank our team, the network of renowned experts and clinicians and all international and French institutions for their commitment to this work (Center for Research in Transplantation and Immunology, Nantes University Hospital: Pr. Gilles Blancho, Pr. Jean-Paul Soulillou, Dr. Sophie Brouard; Bpifrance; The London School of Medicine and Dentistry: Pr. Thomas T. MacDonald; The Institute of Digestive Diseases (IMAD), Nantes; Icahn School of Medicine at Mount Sinai, New York: Pr. Miriam Merad).”
OSE-127 is being developed in partnership with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases and in parallel, Servier plans a development in Sjögren’s syndrome. The product is currently under a Phase 1 clinical trial in which the first healthy volunteers were enrolled and dosed in December 2018. This first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial, aims to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers. Secondary endpoints include measures of pharmacokinetics, pharmacodynamics and immunogenicity to help assess and understand how the drug is absorbed and metabolized. In addition, exploratory biomarkers will be used to assess OSE-127’s potential for the treatment of inflammatory autoimmune diseases.
1 Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).
IL-7
receptor influences anti-TNF responsiveness and T cell gut homing in
inflammatory bowel disease
Lyssia Belarif,1
Richard Danger,2,3 Laetitia Kermarrec,4 Véronique
Nerrière-Daguin,2,3 Sabrina Pengam,1 Tony Durand,4
Caroline Mary,1 Elise Kerdreux,5 Vanessa
Gauttier,1 Aneta Kucik,6 Virginie Thepenier,1
Jerome C. Martin,7,8,9 Christie Chang,7,8,9 Adeeb
Rahman,7,10,11 Nina Salabert-Le Guen,2,12,13,14
Cécile Braudeau,2,12,13 Ahmed Abidi,2,15 Grégoire
David,4 Florent Malard,2 Celine Takoudju,4
Bernard Martinet,2,3 Nathalie Gérard,2,3 Isabelle
Neveu,4,5 Michel Neunlist,4,5 Emmanuel Coron,4,5
Thomas T. MacDonald,6 Pierre Desreumaux,16 Hoa-Le
Mai,2,3 Stephanie Le Bas-Bernardet,2,3 Jean-François
Mosnier,2,17 Miriam Merad,7,8,9,11 Régis Josien,2,3,12,14
Sophie Brouard,2,3 Jean-Paul Soulillou,2 Gilles
Blancho,2,3 Arnaud Bourreille,4,5 Philippe
Naveilhan,4,5 Bernard Vanhove,1 and Nicolas Poirier1
1OSE Immunotherapeutics, Nantes, France. 2Centre de Recherche en Transplantation et Immunologie (CRTI), UMR 1064, Inserm, Université de Nantes, Nantes, France. 3Institut de Transplantation Urologie Néphrologie (ITUN), Centre Hospitalier Universitaire de Nantes (CHU Nantes), Nantes, France. 4Institut des Maladies de l’Appareil Digestif (IMAD), The Enteric Nervous System in Gut and Brain Disorders, Université de Nantes, INSERM, Nantes, France. 5CHU Nantes, IMAD, Nantes, France. 6Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom. 7Precision Immunology Institute, 8Tisch Cancer Institute, 9Department of Oncological Sciences, 10Charles Bronfman Institute for Personalized Medicine, and 11Human Immune Monitoring Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA. 12CHU Nantes, Laboratoire d’Immunologie, Center for Immuno Monitoring Nantes-Atlantique (CIMNA), Nantes, France. 13LabEx Immunograft Oncology (IGO), Nantes, France. 14Université de Nantes, Faculté de Médecine, Nantes, France. 15Université de Tunis El Manar, Laboratoire de génétique, immunologie et pathologies humaines, Faculté des sciences de Tunis, Tunis, Tunisia. 16Hepato-Gastroenterology Department, Claude Huriez Hospital, University of Lille 2, Lille, France. 17CHU Nantes, Service d’Anatomie et Cytologie Pathologiques, Nantes, France.
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. The most advanced therapeutic-candidate, 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) and in Phase 2 testing in pancreatic cancer in combination
with checkpoint inhibitor Opdivo®. FR104 (an anti-CD28 mAb) has
successfully completed Phase 1 testing and has potential to treat
autoimmune diseases. BI 765063 (OSE-172) (anti-SIRPa monoclonal
antibody) is under a license and collaboration agreement with Boehringer
Ingelheim ; this checkpoint inhibitor has received CTA from French and
Belgian health authorities for a Phase 1 clinical trial in multiple
cancer indications. BiCKI® is a bispecific fusion protein platform built
on the key backbone component anti-PD-1 (OSE-279) and targeting
innovative targets. OSE-127 (monoclonal antibody targeting the CD127
receptor, the alpha chain of the interleukin-7 receptor) is partnered
with Servier under an option agreement 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. OSE-127 is
currently under Phase 1 clinical trial.
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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.
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and does not undertake any obligation to update or revise the
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