OSE Immunotherapeutics to Present New Clinical and Preclinical Data at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

Data on Tedopi®, BiCKI® and CLEC-1 programs being presented in three poster presentations – November 12 - 14, 2021

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

OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) announces that three abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 36^th Annual Meeting in Washington D.C. (and virtually) held on November 10 – 14, 2021. The three posters will include new clinical and translational data on Tedopi® (neoepitope-based cancer vaccine) in non-small cell lung cancer and the latest data on preclinical programs BiCKI®-IL-7 (bifunctional therapy targeting PD-1 and IL-7) and CLEC-1 (new “Don’t Eat Me” myeloid checkpoint target).

POSTER PRESENTATION DETAILS

- Title: “Combined exploratory immunophenotyping and transcriptomic tumor analysis in patients treated with OSE2101 vaccine in HLA-A2+ advanced non-small cell lung cancer (NSCLC) from the ATALANTE-1 trial” (poster #366)
Category: Clinical trials completed
Presentation Time: November 12 - 14, 2021
Location: Poster Hall

- Title: “Long-term anti-tumor preclinical efficacy of an optimized anti-PD-1/IL-7 bifunctional antibody sustaining activation of progenitor stem-like CD8 TILs and disarming Treg suppressive activity” (poster #794)
Category: Immunoconjugates and chimeric molecules
Presentation Time: November 12 - 14, 2021
Location: Poster Hall

- Title: “Preclinical efficacy of CLEC-1 antagonist as novel myeloid immune checkpoint therapy for oncology” (poster #230)
Category: Checkpoint blockade therapy
Presentation Time: November 12 - 14, 2021
Location: Poster Hall

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