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OSE Immunotherapeutics Receives Notice of Allowance for New U.S. Patent Protecting Anti-IL-7 Receptor Antagonist OSE-127

May 20, 2019

NANTES, France, May 20, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announces that it has received the first notice of allowance of a patent from the United States Patent and Trademark Office (USPTO) strengthening the protection covering anti-interleukin-7 receptor (IL-7R) antagonist OSE-127, a humanized monoclonal antibody targeting the CD127 receptor, the alpha chain of the IL-7R, that has been shown to induce a powerful antagonistic effect on effector T lymphocytes responsible for causing autoimmune pathologies.

The new patent will cover OSE-127 until at least 2035. This first notice of allowance in the U.S. is a major step in strengthening the product’s protection and should facilitate the grant of additional patents in other major territories covered by the same patent family.

“We are very pleased with this first U.S. notice of allowance for a patent application that strengthens OSE-127 intellectual property and further validates the product’s novel and differentiated mechanism of action as an IL-7R full-antagonist. While reinforcing our global patent portfolio for OSE-127, we are also advancing the product’s development through a phase 1 clinical trial, with an aim of providing a potential best-in-class treatment for debilitating autoimmune diseases, including inflammatory bowel diseases and Sjögren’s syndrome,” commented Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

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 in a Phase 1 trial evaluating 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.

*Servier is an international pharmaceutical company, governed by a non-profit foundation, with headquarters in the Paris (France) metropolitan area.

ABOUT OSE-127OSE-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 ) which have a positive impact in autoimmune diseases.

ABOUT OSE ImmunotherapeuticsOSE 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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Contacts

OSE Immunotherapeutics U.S. Media: LifeSci Public Relations Sylvie Détry Darren Opland, Ph.D. Sylvie.detry@ose-immuno.com darren@lifescipublicrelations.com +33 153 198 757 +1 646 627 8387 French Media: FP2COM U.S. and European Investors Florence Portejoie Chris Maggos fportejoie@fp2com.fr chris@lifesciadvisors.com +33 607 768 283 +41 79 367 6254

Forward-looking statementsThis 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 2019, including the annual financial report for the fiscal year 2018, 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.

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