NANTES - OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announced the European Patent Office's (EPO) issuance of a notice of allowance for its Phase-2 ready product FR104, a first-in-class selective CD28-antagonist.
Specifically, this European patent will provide additional protection covering novel dosing regimen of FR104 for the prevention and treatment of T-lymphocyte-mediated autoimmune diseases, inflammatory diseases, transplantation and graft-versus-host disease (GVHD) until 2036.
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, commented, 'This new notice of allowance from the EPO broadensthe global patent protection of FR104 andsimilar patent applications are pending in other countries. As a Phase 2-ready product with Phase 1signals of clinical efficacy andstrong safety profile, FR104 is a valuable asset with great potential for further developmentto meet patients' needs in a number of autoimmune conditions, in transplantation and as prevention of graft-versus-host disease following hematopoietic stem cell transplantation.'
CD28 blockade by FR104 tackles memory pathogenic T lymphocytes while favoring Treg suppressive function. This novel mechanism of controlling immune synapses potentially offers new therapeutic options in multiple inflammatory and autoimmune diseases, transplantation and GVHD where T cells are involved. The results from FR104's Phase 1 clinical study have shown initial signals of efficacy, a good safety profile and the recommended dose for a Phase 2, further supporting the continued clinical development of this asset.
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 several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile:
Tedopi (innovative combination of neoepitopes): the company's most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure.
In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in monotherapy and in combination with checkpoint inhibitor Opdivo.
BI 765063 (OSE-172, anti-SIRP monoclonal antibody): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors.
FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation.
OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjogren's syndrome (Servier sponsor) to start in Q4 2020.
BiCKI: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity.
CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neoepitopes. Positive preclinical and human ex vivo results in August 2020, clinical trial expected to start end of 2020/early 2021.
Due to the COVID-19 crisis, accrual of new patients in the clinical trial TEDOPaM is temporarily suspended and initiation timelines for both Phase 2 trialsof OSE-127 could be impacted during the coming months.
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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.
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