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OSE Immunotherapeutics Announces Issuance of Canadian Patent and Notice of Allowance of U.S. Patent Protecting CD28-Antagonist Immunotherapy FR104

Cover therapeutic applications of FR104 through 2031 In Canada and in the U.S. in autoimmune diseases, chronic inflammatory diseases and graft applications

NANTES, France, April 09, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) announces that it has strengthened its intellectual property rights for its Phase 2-ready product FR104, a monoclonal antibody antagonist of CD28, through the granting of a patent by the Canadian Intellectual Property Office (CIPO). The patent covers the product and its therapeutic applications in T-lymphocyte-mediated autoimmune diseases, chronic inflammatory diseases and graft applications. OSE has also received a notice of allowance of a patent from the United States Patent and Trademark Office (USPTO), providing additional protection covering the use of FR104 in the treatment of T-lymphocyte-mediated chronic inflammatory diseases.

FR104 and its applications in autoimmune diseases, chronic inflammatory diseases and graft applications are  now protected by patents in Europe, the U.S., Canada and Japan, giving the product significantly consolidated intellectual property and value.

“These new allowances from the CIPO and USPTO reinforce the global patent protection of FR104 and its position as a key product in our autoimmune diseases portfolio. As a Phase 2-ready product with a strong clinical and biological safety profile, and initial signals of clinical efficacy, FR104 is a valuable asset with great potential for further development in a number of autoimmune conditions. We are exploring the best options for continuing the development of our product in autoimmune diseases, including worldwide partnering opportunities,” comments Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

CD28 blockade by FR104 controls T effector functions while potentiating regulatory T cells. This novel mechanism of controlling immune synapses potentially offers new therapeutic options in multiple inflammatory and autoimmune diseases where T cells are involved and there are important unmet medical needs. Positive safety and biological activity results from FR104’s Phase 1 proof-of-concept clinical study, alongside the preclinical safety profile and efficacy data in multiple preclinical models of autoimmune and inflammatory diseases, further support the continued clinical development of this asset in phase 2.

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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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 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.