Tedopi (OSE 2101) / OSE Immunotherapeutics, Chong Kun Dang - LARVOL DELTA

A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study. (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fondazione Ricerca Traslazionale

Circulating tumor DNA • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi in Non-Small Cell Lung Cancer (GlobeNewswire) - "A second IDMC review is anticipated in Q1 2026. Completion of recruitment in the ARTEMIA trial is foreseen for end of 2026, with readout for primary endpoint of overall survival in Q1 2028."

DSMB • Enrollment status • P3 data • Non Small Cell Lung Cancer

OSE2101 plus docetaxel or nivolumab as second-line therapy in metastatic non-small cell lung cancer (mNSCLC) progressing after first-line chemoimmunotherapy (Combi-TED) (ESMO 2025) - P2 | "Legal entity responsible for the study Fondazione Ricerca Traslazionale (FoRT). Funding Sponsored by Fondazione Ricerca Traslazionale (FoRT), with the support of OSE Immunotherapeutics SA."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Net treatment benefit in ARTEMIA trial comparing OSE2101 to docetaxel in patient with non-small cell lung cancer (NSCLC): Outcomes prioritization based on investigators preferences (ESMO 2025) - P3 | "Legal entity responsible for the study OSE Immunotherapeutics SA. Funding OSE Immunotherapeutics SA."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OSE Immunotherapeutics Reports First Half 2025 Financial Results (GlobeNewswire) - "Research and development expenses increased by 6.7% over the period, amounting to €14.8 million in the first half of 2025, compared to €13.9 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 trial of Tedopi – Artemia – actively recruiting...Operating loss amounted to €(15.8) million in the first half of 2025, compared to a profit of €63.3 million a year earlier, essentially reflecting an exceptional income in 2024 related to the AbbVie licensing agreement on OSE-230 and the amendment on the BI 765063 (OSE-172) agreement as well as the asset purchase agreement from the “cis-targeting” anti-PD1/cytokine platform by Boehringer Ingelheim."

Commercial • Immunology • Solid Tumor

OSE Immunotherapeutics and the FoRT Foundation Announce Completion of Enrollment in Combi-TED, a Phase 2 Clinical Trial Evaluating Tedopi in Combination with Nivolumab or Docetaxel in Patients with Non-Small Cell Cancer (GlobeNewswire) - "As planned, 105 patients were enrolled in the clinical study, and the readouts are expected in the second half of 2026."

Enrollment closed • P2 data • Non Small Cell Lung Cancer

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: OSE Immunotherapeutics | N=24 ➔ 41

Enrollment change • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MSI

Clear Strategy, Focused on Value Creation (GlobeNewswire) - "Tedopi is currently in a pivotal phase 3 clinical trial for non-small cell lung cancer. Enrollment is expected to be completed in the second half of 2026, with the first readout – based on overall patient survival – anticipated by the end of 2027. Additional clinical data are expected in 2026 from the TEDOPaM Phase 2 combination study in pancreatic cancer (survival follow-up), the Tedova Phase 2 combination study in ovarian cancer (readout expected in the first half of 2026), and the Combi-TED Phase 2 combination study in lung cancer (readout expected in the second half of 2026)."

Enrollment status • P2 data • P3 data • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

TEDOPAM: OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (clinicaltrials.gov) - P2 | N=106 | Active, not recruiting | Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • UGT1A1

Maintenance with OSE2101 plus FOLFIRI vs FOLFIRI alone after FOLFIRINOX (FFX) induction in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC): Primary endpoint results of a randomized TEDOPAM GERCOR D17-01 PRODIGE 63 trial. (ASCO 2025) - P2 | "TEDOPAM met its primary objective with minimal toxicity and positive outcomes of adding OSE2101 cancer vaccine to maintenance FOLFIRI, albeit mitigated by unexpectedly favorable OS in the control arm. Two complete responses were observed when adding OSE2101. Further follow-up is ongoing and translational analysis planned."

Clinical • Metastases • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase 3 trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy. (ASCO 2025) - P3 | "The ARTEMIA phase 3 study aims to confirm the benefit on survival and quality of life of the therapeutic cancer vaccine OSE2101 compared to docetaxel in second-line treatment of HLA-A2 positive patients with NSCLC and secondary resistance to immune checkpoint inhibitor. Recruitment is ongoing in North America and Europe."

Clinical • IO biomarker • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • ROS1

OSE Immunotherapeutics strengthens Growth Strategy: Accelerates key pillars of Inflammation and Immuno-Oncology (OSE Immunotherapeutics Press Release) - "Earlier this week, we shared our progress with Tedopi...To summarize, our pivotal Phase 3 program in NSCLC with Tedopi is progressing well, keeping us in the race to register the first therapeutic cancer vaccine. Enrolment is advancing across 144 clinical sites in Europe and North America and is on track to complete in the second half of 2026. The data readout is expected in 2027...We are looking forward to additional Phase 2 readouts in combination with anti-PD1 from our ovarian and lung cancer trials in 2026."

P2 data • P3 data • Non Small Cell Lung Cancer • Ovarian Cancer

ARTEMIA - International pivotal Phase 3 study in Non-Small Lung Cancer (NSCLC): Trial in Progress (GlobeNewswire) - "A 'Trial in Progress' poster titled: 'Phase 3 trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapy' was also presented at ASCO 2025....This pivotal trial is conducted in 14 countries across the United States, Canada, Europe, and United Kingdom. ARTEMIA will include 363 patients and enrolment is progressing according to the study program."

Trial status • Non Small Cell Lung Cancer

TEDOPaM - Phase 2 first positive results in advanced pancreatic cancer: Oral communication presented by the French GERCOR Oncology Group, trial sponsor (GlobeNewswire) - P2 | N=106 | TEDOPAM (NCT03806309) | "TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI (Arm A) and cancer vaccine Tedopi (OSE2101) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with no progression after eight cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with a 12-month OS of 65% in Arm B, and minimal toxicity for Tedopi combined with FOLFIRI as maintenance treatment."

P2 data • Pancreatic Ductal Adenocarcinoma

OSE Immunotherapeutics Highlights Abstracts Selected for Presentation at ASCO 2025 (GlobeNewswire) - "OSE Immunotherapeutics SA...announced that several abstracts highlighting the Company's innovative assets have been selected for presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 1-5, 2025, in Chicago, Illinois."

Clinical • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

ARTEMIA phase 3 study: A randomized, open-label trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic non-small cell lung cancer and secondary resistance to immune checkpoint inhibitors. (PubMed, Lung Cancer) - No abstract available

Checkpoint inhibition • Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OSE Immunotherapeutics Reports Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "TEDOVA: Completed Phase 2 trial enrollment in December 2024 in HLA-A2 positive patients with ovarian cancer (alone or in combination with pembrolizumab), led by French oncology group ARCAGY-GINECO. Readout expected in Q2 2026. CombiTED: Patient enrollment on track to complete in Q2 2025 for Phase 2 trial in second-line HLA-A2 positive patients with NSCLC in combination with nivolumab or docetaxel. The trial is led by Italian foundation FoRT. Readouts are expected in H2 2026."

P2 data • Trial status • Non Small Cell Lung Cancer • Ovarian Cancer

OSE Immunotherapeutics and GERCOR Announce Positive Topline Phase 2 Result for Clinical Trial TEDOPaM Evaluating OSE2101 (Tedopi) in Advanced Pancreatic Cancer (GlobeNewswire) - P2 | N=106 | TEDOPAM (NCT03806309) | "TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI (Arm A) and cancer vaccine OSE2101 (Tedopi) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with PDAC with no progression after eight cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). 107 patients were enrolled with a 1:1 ratio...The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with minimal toxicity for OSE2101 (Tedopi) combined with FOLFIRI as maintenance treatment. Further follow-up and translational analyses are ongoing, with detailed results to be presented at upcoming medical congresses."

P2 data • Pancreatic Ductal Adenocarcinoma

OSE Immunotherapeutics Announces Positive Clinical Progress for Late-Stage Proprietary Cancer Vaccine Tedop (GlobeNewswire) - "CombiTED: Completion of patient enrollment in Phase 2 study of Tedopi in combination with Opdivo in second-line NSCLC expected in Q1 2025; a trial sponsored and conducted by the Italian foundation FoRT. Readouts expected in the H2 2026. TEDOPaM: Patient enrollment completed last year in the Phase 2 study of Tedopi in combination with chemotherapy in advanced or metastatic pancreatic ductal adenocarcinoma; a trial sponsored and conducted by the French oncology cooperative group GERCOR. Results expected in H1 2025."

Enrollment status • P2 data • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

OSE Immunotherapeutics Announces Positive Clinical Progress for Late-Stage Proprietary Cancer Vaccine Tedopi (GlobeNewswire) - "ARTEMIA: Clinical trial protocol approved globally. Most countries and sites activated, with full activation expected in H1 2025. First patients enrolled in this international Phase 3 registration study of Tedopi in monotherapy in second-line Non-Small Cell Lung Cancer (NSCLC). TEDOVA: Completion of patient enrollment in the Phase 2 study of Tedopi alone or in combination with Keytruda in ovarian cancer; a trial sponsored and conducted by the French oncology cooperative group ARCAGY-GINECO. Readouts expected in Q2 2026."

P2 data • Trial status • Non Small Cell Lung Cancer • Ovarian Cancer

TEDOVA: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: ARCAGY/ GINECO GROUP | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Oncology • Ovarian Cancer • Solid Tumor

ARTEMIA: Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor (clinicaltrials.gov) - P3 | N=363 | Recruiting | Sponsor: OSE Immunotherapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Dec 2024

Checkpoint inhibition • Enrollment open • Metastases • Trial initiation date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 (ESMO 2024) - "An interim analysis is planned. The ARTEMIA phase 3 study aims to confirm the benefit on survival and quality of life of the therapeutic cancer vaccine OSE2101 compared to docetaxel in second-line treatment of HLA-A2 positive patients with NSCLC and secondary resistance to immune checkpoint inhibitor."

Clinical • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • ROS1

OSE Immunotherapeutics Announces Global Launch of Artemia Phase 3 Registration Study for Cancer Vaccine Tedopi in Second-Line Non-Small Cell Lung Cancer (GlobeNewswire) - "OSE Immunotherapeutics SA...today announced the launch of its international Phase 3 clinical trial named ‘Artemia’ of Tedopi, the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC)....Artemia is an international, randomized, open-label Phase 3 trial comparing the efficacy and safety of Tedopi monotherapy versus standard of care in HLA-A2 positive patients with metastatic NSCLC with secondary resistance* to immune checkpoint inhibitor (ICI). The primary endpoint is overall survival. This confirmatory pivotal trial will include 363 patients, and aims at supporting the regulatory registration of Tedopi® in second-line treatment of NSCLC in Europe and North America."

New P3 trial • Non Small Cell Lung Cancer

Phase 3 Trial of OSE2101 Versus Docetaxel in Patients with Non-Small Cell Lung Cancer & Secondary Resistance to Immunotherapy (IASLC-WCLC 2024) - "For sample size calculation, assuming a hazard ratio of 0.70 with a power of 80% using a 2-sided log-rank test, 363 patients will be enrolled to reach 269 events. An interim analysis is planned."

Clinical • IO biomarker • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • ROS1