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OSE Immunotherapeutics Receives First Notice of Allowance of a Patent for Use of Tedopi® to Treat Brain Metastasis

January 15, 2019

Granted by the Japanese Patent OfficeFurther Strengthens Global Intellectual Property Portfolio for Tedopi® in Immuno-Oncology

NANTES, France, Jan. 15, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced that the Japanese Patent Office has issued the notice of allowance for a new patent family related to Tedopi®, a combination of neoepitopes, for use in the treatment of brain metastasis originating from cancers, including non-small cell lung cancer (NSCLC), in HLA-A2 positive patients. This patent provides a protection covering the use of Tedopi® in the treatment of brain metastasis until 2034.

Brain metastasis is associated with poor prognosis as well as significant morbidity, creating a large unmet medical need. The new Tedopi® patent originated from Phase 2 results conducted in NSCLC patients. In the study, patients with brain metastasis showed longer than expected overall survival as well as longer time without disease progression(1), considering the advanced stage and the poor prognosis of these brain metastasis patients heavily previously treated.

“This new patent family, first granted in Japan, is an important step toward further strengthening and expanding our Tedopi® immuno-oncology portfolio. The product’s use to the treatment of brain metastasis originating from cancers in HLA-A2 positive patients demonstrates the product’s therapeutic potential. Tedopi® is currently undergoing Phase 3 testing in NSCLC patients following checkpoint inhibitor failure, a patient population with no currently approved therapeutic option, representing an important potential market. In addition, Tedopi® is being evaluated in combination with Opdivo®, an anti-PD-1 checkpoint inhibitor, in a Phase 2 trial in pancreatic cancer. Tedopi® is positioned as a leading asset in multiple oncology indications requiring for novel therapeutic approaches and in patient populations for which a significant medical need exists,” said Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

Tedopi is a combination of 10 neoepitopes selected and optimized from five tumor associated antigens able to generate a specific response against cytotoxic T-cells expressing at least one of these tumor associated antigens and an associated helper T-cell response.

(1) J. Nemunaitis et al, Denver IASLC 2015

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. In April 2018, Boehringer Ingelheim and OSE signed a global license and collaboration agreement to develop preclinical checkpoint inhibitor OSE-172 (anti-SIRPa monoclonal antibody) in multiple cancer indications. 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 +33 143 297 857 +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 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.