OSE Immunotherapeutics Announces Issuance of a New Patent in Japan for Tedopi on Inducing Early T-Lymphocyte Memory Response – Yahoo Finance

Further Strengthens Global Intellectual Property Portfolio for Tedopi in Immuno-Oncology

Regulatory News:

OSE Immunotherapeutics (ISIN: FR0012127173; Mnmo: OSE) (Paris:OSE) today announced that the Japanese Patent Office has issued a new patent family related to Tedopi, a combination of neoepitopes, protecting the products method for inducing early T-lymphocyte memory response for use in the treatment of cancer in HLA-A2 positive patients. This patent provides a protection until 2035.

Tedopi is a combination of 10 neo-epitopes, selected and optimized from five tumor associated antigens inducing a specific immune response in positive HLA-A2 patients. In association with T helper cells, the memory T-lymphocytes recognize specifically at least one of these tumor associated antigens expressed by the tumor cells and generate a specific cytotoxic response against them.

Due to this specific mechanism of action, activated specific T memory lymphocytes are key cells in cancer treatment and immunosurveillance.

"This new patent family, granted in Japan, further expands the patent protection for Tedopi and strengthens our immuno-oncology portfolio. This allowance further validates a specific mechanism of action inducing an early T-lymphocyte memory response in HLA-A2 positive patients, which represent 45% of the population, and covering all cancers. Moreover, with more than one million new cancer cases in Japan in 2018*, and a growing oncology drug market in this country and across the world, Tedopi is positioned as a leading asset in multiple oncology indications in a broad population of patients," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.

Tedopi is currently being evaluated in a Phase 3 trial, called Atalante 1, in advanced non-small cell lung cancer (NSCLC) for HLA-A2 positive patients after failure from previous treatment with PD-1/PD-L1 checkpoint inhibitors. Even with recent advances in treatment options, the majority of NSCLC patients still fail to respond to checkpoint inhibitor therapy**, creating a great need for an effective new option for these patients. Results from the first step of this ongoing Phase 3 trial are expected by the end of Q1 2020. Tedopi is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.

* Shibata et al., Japan oncology market overview: Current and future perspectives; Journal of Generic Medicines, 2019

** Haslam et al., Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs; JAMA Netw Open. 2019;2(5):e192535.

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 autoimmune 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) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. 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 Sjgren syndrome. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; planned Phase 2 studies in ulcerative colitis and Sjgrens syndrome to start in 2020.

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For more information: https://ose-immuno.com/en/

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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 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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Contacts

OSE Immunotherapeutics Sylvie Dtry Sylvie.detry@ose-immuno.com +33 153 198 757

French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283

U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387

U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254

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OSE Immunotherapeutics Announces Issuance of a New Patent in Japan for Tedopi on Inducing Early T-Lymphocyte Memory Response - Yahoo Finance