OSE Immunotherapeutics announces the international launch of Artemia, the Phase 3 registration study of the therapeutic vaccine Tedopi® in second-line treatment of non-small cell lung cancer
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Study begins in the United States, Canada, Europe and the United Kingdom following approval by regulatory authorities in 14 countries.
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Presentations’Trial in Progress’ at the conference’2024 World Conference on Lung Cancer’ (WCLC) in San Diego and at the Congress’European Society for Medical Oncology Congress 2024’ (ESMO) in Barcelona.
Nantes, France, September 10, 2024, 7:30 a.m. – OSE Immunotherapeutics SA (ISIN: FR0012127173; Ticker: OSE), announces the initiation of its international Phase 3 clinical study, named ‘Artemia’, evaluating Tedopi®, a ‘ready-to-use’ neoepitope-based therapeutic cancer vaccine, as a second-line treatment in patients suffering from non-small cell lung cancer (NSCLC). The study dossier, reviewed and approved by international health agencies in 14 countries (United States, Canada, Europe and the United Kingdom) is a pivotal trial aimed at supporting the registration of Tedopi®, in combination with the companion diagnostic test designed to identify HLA-A2 positive patients.
Artemia is an international, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of Tedopi® as monotherapy administered in second-line versus the standard of care in HLA-A2 positive patients with metastatic NSCLC with secondary resistance* to checkpoint inhibitors (CPIs). The primary endpoint is overall survival. This confirmatory pivotal trial will enroll 363 patients and aims to support regulatory registration of Tedopi® as a second-line treatment for NSCLC in Europe and North America.
Silvia Comis, Director of Clinical Development and Regulatory Affairs at OSE Immunotherapeuticscomments: “We are very pleased to start the last step before the registration of our cancer vaccine Tedopi®, evaluated as monotherapy in second-line treatment based on the promising positive results of our first Phase 3 in third-line NSCLC. These results demonstrated that re-arming the immune system with a therapeutic vaccine in metastatic patients could prolong survival while preserving quality of life in the targeted patient population.”
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Nicolas Poirier, CEO of OSE Immunotherapeuticsadd: “This international registration trial is now on track and we look forward to confirming the therapeutic benefit of Tedopi® in patients with metastatic cancer. Tedopi® is the most advanced therapeutic cancer vaccine in clinical development and represents the first treatment option to address a significant unmet medical need and a largely unexplored market potential in the second-line treatment of metastatic or advanced NSCLC.”
NSCLC represents 85%** of all lung cancers and the HLA-A2 phenotype is found in approximately 45% of the overall population. Based on the selection of patients after failure of a CPI, the population targeted by Tedopi® in second-line treatment is therefore considered rare and with a high medical need. Given the very broad use of anti-PD(L)-1, and based on data on CPI failures, the population targeted by Tedopi® could be estimated at 46,000 patients per year in 7 major markets across the United States, Europe and Japan.
Un poster ‘Trial in Progress’ intitulé : “Phase 3 Trial of OSE2101 Versus Docetaxel in Patients with Non-Small Cell Lung Cancer & Secondary Resistance to Immunotherapy” was presented by the Dr Stephen LiuAssociate Professor and Director of the Department of Thoracic Oncology at Georgetown University Lombardi Comprehensive Cancer Center (Washington DC, USA), coordinating investigator and member of the Steering committee from the Artemia trial, to the 2024 conference World Conference on Lung Cancer (September 7-10, San Diego, CA, USA).
The Dr Liu comments: “I am very excited to see the Artemia trial begin in the United States. With an off-the-shelf vaccine approach, we can offer a safer and better-tolerated option than chemotherapy to patients with advanced lung cancer. By appropriately activating patients’ immune systems, we hope to significantly extend survival.”
Un second poster ‘Trial in Progress’ intitulé : “Phase III trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy” will also be presented by Dr. Stephen Liu at the conference European Society for Medical Oncology (September 13-17, Barcelona, Spain).
* Secondary resistance: after at least 12 weeks of maintenance treatment with CPI monotherapy ((Task force SITC 2020 – Kluger H et al 2020).
** https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotechnology company that develops products first-in-class in immuno-oncology (IO) and immuno-inflammation (I&I). His clinical portfolio first-in-class understand :
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Tedopi® (immunotherapy of activation of specific T lymphocytes against cancer cells, ” off-the-shelf » based on neo-epitopes): the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in non-small cell lung cancer (NSCLC) in patients with secondary resistance after failure of a checkpoint inhibitor; randomized Phase 3 registration trial (Artemia) underway in second-line NSCLC in HLA-A2+ patients with secondary resistance. Other trials, promoted by clinical groups in oncology, of Tedopi® in combination are underway in solid tumors.
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OR-279 (anti-PD1): First positive results from the ongoing Phase 1/2 study in solid tumors.
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FR104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; Phase 1/2 underway in kidney transplantation (under the promotion of the Nantes University Hospital); Phase 1 successfully completed in the United States (promoter Veloxis Pharmaceuticals, Inc.).
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Anti-SIRPα monoclonal antibodies developed in partnership with Boehringer Ingelheim (BI) in advanced solid tumors and cardiovascular, renal and metabolic (CVRM) diseases; positive results from Phase 1 dose escalation in monotherapy and in combination; start of Phase 2 in CVRM diseases planned for the end of 2024.
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ABBV-230 (ChemR23 agonist monoclonal antibody) developed in partnership with AbbVie in chronic inflammation.
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OSE Immunotherapeutics aims to create significant value through its three proprietary research platforms, central to its goal of delivering next-generation immunotherapy treatments first-in-class :
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Pro-resolving monoclonal antibodies platform which aims to improve the resolution of inflammation and optimize the therapeutic potential of targeting neutrophils and macrophages in I&I. ABBV-230 (licensed to AbbVie) is the first candidate from this platform, other research programs are underway on new GPCR targets.
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Myeloid Checkpoint Platform which aims to optimize the therapeutic potential of myeloid cells in IO by targeting regulatory immune receptors expressed by macrophages and dendritic cells. BI 770371 (licensed to Boehringer Ingelheim) is the most advanced candidate generated by this platform. Other research programs are underway, in particular the new monoclonal antibody anti-CLEC-1 which has shown positive preclinical results as monotherapy.
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BiCKI® Platforma bifunctional fusion protein platform built around an anti-PD1 backbone fused to novel immunotherapy targets to increase antitumor efficacy with ‘cis-potentiating’ tumor-specific T cells. A first program was acquired by Boehringer Ingelheim.
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Therapeutic mRNA platform which enables the delivery of an innovative RNA-encoded immunotherapy to the site of inflammation to locally control and/or suppress the immune response and inflammation.
More information on OSE Immunotherapeutics assets is available on the Company’s website: http://ose-immuno.com
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Forward-Looking Statements
This press release contains implicitly or expressly information and statements that may be considered forward-looking information concerning OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections based on hypotheses or assumptions made by OSE Immunotherapeutics’ management in light of their experience and their perception of historical trends, current economic and industry conditions, future developments and other factors they believe to be appropriate.
These forward-looking statements can often be identified by the use of the conditional and by the verbs “expect”, “anticipate”, “believe”, “plan” or “estimate” and their declensions and conjugations as well as by other similar terms. Although the management of OSE Immunotherapeutics believes that these forward-looking statements are reasonable, the shareholders of OSE Immunotherapeutics and other investors are alerted to the fact that their realization is subject by nature to numerous known or unknown risks and uncertainties, difficult to predict and beyond the control of OSE Immunotherapeutics. These risks may imply that the actual results and developments actually achieved differ significantly from those indicated or induced in these forward-looking statements. These risks include in particular those developed or identified in the public documents filed by OSE Immunotherapeutics with the AMF. Such forward-looking statements in no way constitute a guarantee of future performance. This press release includes only summary information and should be read in conjunction with the OSE Immunotherapeutics Universal Registration Document, filed with the AMF on April 30, 2024, including the 2023 annual financial report, available on OSE Immunotherapeutics’ website. OSE Immunotherapeutics does not undertake any obligation to update any forward-looking information or statements, except as required by applicable laws and regulations.
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