OSE Immunotherapeutics to Host Today a Virtual “Immuno-Oncology R&D Day”

• R&D Day to highlight the Company’s strategy on its leading clinical programs and emerging firs-in-class portfolio in immuno-oncology;
• Presentations by leading clinicians to feature the latest data on Tedopi® and BI 765063.

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

OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) will host a virtual R&D Day on Tuesday, October 12^th, 2021 at 4:00 p.m. CEST/ 10:00 a.m. EDT.

Date: Tuesday, October 12^th, 2021
Time: 4:00 p.m. - 7:00 p.m. CEST / 10:00 a.m. - 1:00 p.m. EDT

Details for the virtual R&D Day :

The live webcast of the event will be available from 3:30 p.m. CEST / 9:30 a.m. EDT
at the following link:
https://www.financelive.fr/oseo-immuno/inscription/

A replay of the webcast following the event will be available for 90 days on the Company’s website:
https://ose-immuno.com/en/

The event, which will feature presentations by leading clinicians as well as key members of the OSE Immunotherapeutics management team, will provide an update on:

• The Company’s strategy to build a leading portfolio of best- and first-in-class cancer immunotherapies.
• OSE’s goal to position Tedopi® as a new standard of care in non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor (ICI) failure and its ongoing clinical development as a maintenance therapy for ovarian and pancreatic cancers.
• Recent clinical data supporting development of first-in-class CD47/SIRPα pathway targeting antibody BI 765063 alone and in combination with anti-PD-1 ezabenlimab in solid tumours.
• OSE’s emerging best- and first-in-class immuno-oncology portfolio which includes a novel myeloid cell “Don’t Eat Me” signal targeting CLEC-1 and a bispecific antibody platform (BiCKI®) whose first candidate, BiCKI®-IL-7 both combines an anti-PD-1 and the cytokine signal interleukin-7 (IL-7).

Amongst the R&D Day’s key speakers are:

• Pr. Benjamin Besse, Director of Clinical Research at Gustave Roussy (Villejuif, France), will present the positive final results of the Phase 3 Tedopi® clinical program in NSCLC, called Atalante-1, as well as an overview of the current landscape in NSCLC post-ICI.
• Dr. Philippe Cassier, Medical Oncologist at Leon Berard Cancer Center (Lyon, France), will highlight Phase 1 results of BI 765063 alone and in combination with ezabenlimab.

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 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 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/
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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