OSE Immunotherapeutics SA announced that it has received notice of allowance from the European Patent Office for a patent application related to Tedopi®, a neoepitope therapeutic vaccine, protecting a method for manufacturing a ready-to-use peptide emulsion for its use in the treatment of cancers in HLA-A2 positive patients. This patent will provide a protection until 2038.
This new patent notice of allowance granted in Europe reinforces the patent protection for Tedopi® and confirms an optimized industrial manufacturing process using a ready-to-use peptide emulsion.
Tedopi® has shown positive final results from the Atalante 1 Phase 3 study in non-small cell lung patients after secondary resistance to immune checkpoint inhibitors (presented at the 2021 ESMO (European Society for Medical Oncology) Congress). In parallel, additional Phase 2 clinical trials are on-going to continue developing Tedopi® in metastatic NSCLC after failure to first-line chemo-Immune Checkpoint Inhibitors (ICIs) and in other cancer indications in combination with ICIs or with chemotherapy. Such combinations will further reinforce the therapeutic value of Tedopi® in late-stage cancer indications.
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile :
Vaccine platform
• 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 patients after secondary resistance to checkpoint inhibitors.
• In Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
• In Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
• In Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
• CoVepiT: a prophylactic second-generation vaccine against COVID-19, developed using SARS-CoV-2 optimized epitopes against multi variants. Positive preclinical and human ex vivo results. Voluntary and temporary Phase 1 enrollment suspension on-going (July 2021).
Immuno-oncology platform
• BI 765063 (OSE-172, anti-SIRPα mAb on CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy or in combination with ezabenlimab (PD-1 antagonist); Expansion Phase 1 open for screening.
• CLEC-1 (novel myeloid checkpoint target): identification of mAb antagonists of CLEC-1 blocking the “Don’t Eat Me” signal that increase both tumor cell phagocytosis by macrophages and antigen capture by dendritic cells.
• 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.
Auto-immunity and inflammation platform
• FR104 (anti-CD28 monoclonal antibody): Licensing partnership agreement with Veloxis in the organ transplant market; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); Phase 2-ready asset in an autoimmune disease indication.
• OSE-127/S95011 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; in Phase 2 in ulcerative colitis (OSE sponsor) and an independent Phase 2a planned in Sjögren’s syndrome (Servier sponsor).
• OSE-230 (ChemR23 agonist mAb): first-in-class therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
