OSE Immunotherapeutics

Earnings Release • Sep 20, 2021

OSE Immunotherapeutics To Present Positive Results of Tedopi® Phase 3 Clinical Trial in Non-Small Cell Lung Cancer Patients in Secondary Resistance to Immune Checkpoint Inhibitors

At the European Society for Medical Oncology (ESMO) Virtual Congress 2021

OSE Immunotherapeutics reminds the presentation on positive data of Tedopi® in non-small cell lung cancer today at 13:30 CEST

Nantes, France, September 20, 2021 - 7:30 AM CET – OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) announces the presentation of Phase 3 clinical results of Tedopi® today at 13:30 CEST in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress.

Following the publication of the abstract on the ESMO website, Pr. Benjamin Besse, Director of Clinical Research at Gustave Roussy (Villejuif, France) and Principal Investigator, will feature the positive results of the Phase 3 clinical trial with Tedopi® (Atalante 1) in non-small cell lung cancer patients after failure to immune checkpoint inhibitor (PD-1/PD-L1) in a late-breaking oral presentation.

The abstract is available on the ESMO website : https://tinyurl.com/42y4rrt6

Details of the presentation

Proffered Paper session – NSCLC, Metastatic 2

"Activity of OSE-2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO): Final results of Phase 3 Atalante-1 randomised trial"

Presentation number : LBA47
Speaker:	Benjamin Besse (Villejuif, France)
Date:	Monday, September 20th
Lecture time:	13:30 – 13:40 CEST
Location:	Channel 4

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 final results of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients post-ICI failure. 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 is being conducted 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/ Click and follow us on Twitter and LinkedIn

Contacts

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

Forward-looking statements

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

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.