OSE Immunotherapeutics Announces Four Poster Presentations of Neoepitope Combination Tedopi® in Immuno-Oncology at ASCO 2022

NANTES, France, May 23, 2022 (GLOBE NEWSWIRE) — OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and its clinical partners GERCOR, ARCAGY-GINECO and the FoRT Foundation (Fondazione Ricerca Traslazionale), today announced four poster presentations* featuring neoepitope combination Tedopi^® in various cancer indications at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 4 – 7, 2022 in Chicago.

Poster presentation details:

• Title: “A randomized non-comparative phase II study of maintenance OSE2101 vaccine alone or in combination with nivolumab (nivo), or FOLFIRI after induction with FOLFIRINOX in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC): first interim results of the TEDOPaM GERCOR D17-01 PRODIGE 63 STUDY” (Abstract #4148)
  Presenter: Anthony TURPIN, Lille University Hospital, Lille, FR
  Date: Saturday, June 4, 2022
  Time: 8:00 AM–11:00 AM CT

• Title: “Quality of Life (QoL) of OSE2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (IO): Final data of Phase 3 Atalante-1 randomized trial” (Abstract #9094)
  Presenter: Benjamin BESSE, Gustave Roussy Institute, Villejuif, FR
  Date: Monday, June 6, 2022
  Time: 8:00 AM-11:00 AM CT

  Trials in Progress Poster Presentations:

• Title: “TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neoepitope based vaccineOSE2101 alone or in combination with Pembrolizumab vs best supportive care (BSC) as maintenance in platinum-sensitive recurrent ovarian cancer with disease control after platinum” (Abstract #TPS5614)
  Presenter: Alexandra LEARY, Gustave Roussy Cancer Campus, Villejuif, FR
  Date: Saturday, June 4, 2022
  Time: 1:15 PM–4:15 PM CT

• Title: “Combi-TED: A Multicenter, Phase II, Open Label, Randomized Trial Evaluating Efficacy Of Tedopi Plus Docetaxel Or Tedopi Plus Nivolumab As Second-Line Therapy In Metastatic NSCLC Progressing After First-Line Chemo-Immunotherapy” (Abstract #TPS9140)
  Presenter: Federico CAPPUZZO, Istituto Nazionale Tumori Regina Elena, Roma, IT
  Date: Monday, June 6, 2022
  Time: 8:00 AM-11:00 AM CT

* The majority of Annual Meeting abstracts will be released by ASCO on Thursday, May 26, 2022, at 5:00 PM EDT on https://conferences.asco.org/am/abstracts

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 Immuno-Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Immuno-Oncology first-in-class products

• Tedopi^® (innovative neoepitope combination): the Company’s most advanced product; positive results for Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure.
  Other ongoing combination trials sponsored by cooperative clinical research groups in oncology:
  Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
  Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
  Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
• 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 and in combination with ezabenlimab (PD-1 antagonist); ongoing expansion Phase 1. BI sponsored international phase 1b clinical trial ongoing in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC).
• OSE-279, anti-PD1 – advanced preclinical stage.
• BiCKI^®: bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target (for example: BiCKI^®-IL7, preclinical stage) to increase anti-tumor efficacy.

Immuno-Inflammation first-in-class products

• OSE-127/S95011 (humanized monoclonal antibody antagonist of IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; ongoing Phase 2 in ulcerative colitis (sponsor OSE) and ongoing Phase 2a in Sjögren’s syndrome (sponsor Servier).
• FR104 (anti-CD28 monoclonal antibody): licensing partnership agreement with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.); Phase 2 planned in an autoimmune disease indication.
• OSE-230 (ChemR23 agonist mAb): preclinical stage therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.

CoVepiT: a prophylactic second-generation vaccine activating cytotoxic T lymphocytes against COVID-19, developed using optimized epitopes from SARS-CoV2 viral proteins, epitopes non impacted by multi-variants. Shows good tolerance and very good level of T cell immune response. In clinical testing, a long-term memory response was confirmed at 6 months.
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 2022, including the annual financial report for the fiscal year 2021, 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.