OSE Immunotherapeutics Receives New European Patent Notice of Allowance for Tedopi®

Further Strengthens Global Intellectual Property Portfolio for Tedopi^® until 2038

NANTES, France--(BUSINESS WIRE)--Regulatory News:

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) announced today 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.

ABOUT OSE Immunotherapeutics
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; 2^nd 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.

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 Universal Registration Document filed with the AMF on 15 April 2021, including the annual financial report for the fiscal year 2020, 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.

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

Investor Relations
Thomas Guillot
thomas.guillot@ose-immuno.com
+33 607 380 431

Media
U.S. Media: LifeSci Communications
Darren Opland, Ph.D.
darren@lifescicomms.com
+1 646 627 8387

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

Guillaume van Renterghem – LifeSci Advisors
gvanrenterghem@lifesciadvisors.com
+41 76 735 01 31