Tedopi®

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OSE Immunotherapeutics: A Clear Strategy, Balanced Governance, and a Firm Course toward Value Creation
Globenewswire· 2025-09-04 16:00
OSE Immunotherapeutics: A Clear Strategy, Balanced Governance, and a Firm Course toward Value Creation NANTES, France – September 4, 2025, 6 p.m. CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reaffirms its strategic commitment to value creation ahead of the September 30 Annual General Meeting. The Company is focused on developing innovative therapies in immuno-oncology and immuno-inflammation, supported by a robust and differentiated portfolio, a cutting-edge research platform, and stable ...
OSE Immunotherapeutics Reaffirms its Strategic Priorities and Publishes Shareholder Q&A to Restore Information Ahead of AGM
Globenewswire· 2025-08-29 06:00
Core Viewpoint - OSE Immunotherapeutics is reaffirming its strategic priorities and addressing shareholder concerns ahead of its Annual General Meeting (AGM) scheduled for September 30, 2025, amidst shareholder activism and misinformation campaigns [1][3][4] Company Strategy - The company aims to leverage its two main programs, Tedopi® and Lusvertikimab, through strategic partnerships and financing, positioning itself as a leading European biotech in immunotherapy for oncology and inflammation [2][5] - OSE's strategy focuses on maintaining strategic optionality for its lead assets while balancing near-term financing and value creation to avoid premature dilution of shareholder value [5][6] Shareholder Activism - OSE has faced significant shareholder activism, including a misinformation campaign by minority shareholders, which has created confusion ahead of the AGM [3][8] - The company has initiated legal actions to protect all shareholders and ensure a fair debate, as the activist group has allegedly acted against sound governance principles [8][10] AGM and Legal Proceedings - The AGM has been postponed to September 30, 2025, to ensure fair voting conditions based on accurate information regarding the intentions of the activist shareholders [9][11] - Legal proceedings have been initiated to investigate the actions of minority shareholders, with potential implications for their voting rights if irregularities are confirmed [10][11] Financial and Development Plans - Tedopi® is in a pivotal Phase 3 clinical trial for non-small cell lung cancer, with enrollment completion expected in the second half of 2026 and initial readouts anticipated by the end of 2027 [14] - Lusvertikimab's development includes a Phase 2b trial in ulcerative colitis, expected to start in 2026, with readouts in 2027 and 2028 [14] - The company has clarified that the expected cost for the Lusvertikimab trial is in the tens of millions of euros, significantly lower than misleading figures circulated by activist shareholders [14] Governance and Communication - OSE emphasizes its commitment to transparent governance and has published a Shareholder Q&A to counter misinformation and provide clear information on its strategy and financial trajectory [7][12] - The company is dedicated to maintaining open dialogue with shareholders and encourages them to review the Q&A document for accurate information [13]
OSE Immunotherapeutics Proposes Governance Evolution and Reaffirms Strategic Priorities ahead of Annual General Meeting
Globenewswire· 2025-08-25 05:00
Core Viewpoint - OSE Immunotherapeutics is evolving its governance structure to enhance shareholder representation and align with strategic priorities ahead of its Annual General Meeting scheduled for September 30, 2025 [2][4]. Governance Evolution - The new governance framework aims to ensure balanced representation, featuring a Board structure with two current independent members, two new independent directors, two seats for concertist shareholders (representing 20% of equity), one for the CEO, and one for employee shareholders [4][5]. - This restructuring is intended to reflect the diversity of the shareholder base and prepare the company for future strategic opportunities and challenges [4][5]. Strategic Focus - The company remains committed to maximizing the potential of its key therapeutic assets, Tedopi® and Lusvertikimab, through strategic partnerships and financing [5][6]. - OSE Immunotherapeutics is actively pursuing business development partnerships and financing opportunities to ensure both programs are adequately resourced [5][6]. Clinical Development Plans - The company is advancing Tedopi® into a pivotal phase 3 study for lung cancer, with plans to complete enrollment next year [6][7]. - Lusvertikimab will enter a focused phase 2b study to determine optimal dosing and validate its formulation, reflecting feedback from potential partners [6][7]. Annual General Meeting Details - The Annual General Meeting will take place on September 30, 2025, at 10:00 a.m. CET, with electronic voting available for shareholders [8][9]. - A shareholder webinar is scheduled for September 18, 2025, to present key updates and engage with shareholders [10].
OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer
Globenewswire· 2025-06-02 16:00
Core Insights - OSE Immunotherapeutics provided clinical updates on its neo-epitope-based cancer vaccine Tedopi® for pancreatic cancer and non-small cell lung cancer (NSCLC) at the ASCO Annual Meeting, highlighting promising results in ongoing trials [2][3][8]. Company Overview - OSE Immunotherapeutics is a biotech company focused on developing innovative immuno-oncology and immuno-inflammation therapies to meet unmet patient needs [13]. - The company is based in Nantes and Paris and is listed on Euronext [13]. Clinical Trial Updates - The TEDOPaM trial, a Phase 2 study, demonstrated a 12-month overall survival (OS) rate of 65% in patients receiving Tedopi® combined with FOLFIRI chemotherapy, meeting its primary endpoint [6][14]. - The trial enrolled 107 patients, with a median follow-up of 21 months, and reported minimal toxicity associated with Tedopi® [6][14]. - Two complete responses were observed in the experimental arm, while no complete responses were noted in the control arm [14]. Pancreatic Cancer Insights - Pancreatic cancer is a highly aggressive disease, with a five-year survival rate of only 10% globally, and it is projected that new cases will increase by 95.4% by 2050 [10]. - Surgical resection is only feasible for 15-20% of patients at diagnosis, emphasizing the need for effective systemic therapies [11]. NSCLC Developments - The ARTEMIA Phase 3 trial is ongoing, aiming to evaluate Tedopi® as a second-line treatment for HLA-A2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy [9]. - The trial is being conducted across 14 countries and aims to enroll 363 patients [9].