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

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 | "Clinical Trial Registration Number: NCT03806309 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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 | "Clinical Trial Registration Number: NCT06472245 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

TEDOVA: vaccine OSE2101 +/- pembrolizumab as maintenance in platinum-sensitive recurrent ovarian cancer. (PubMed, Future Oncol) - P2 | "Patients in first or second platinum sensitive relapse after poly ADP-ribose polymerase inhibitors and bevacizumab represent an area of unmet medical need. This academic sponsored, international Phase II randomized trial is evaluating the combination of a therapeutic cancer vaccine (OSE2101) with anti-PD1 (pembrolizumab) as maintenance therapy, in patients with platinum-sensitive recurrence regardless of number of prior lines and no progression after platinum-based chemotherapy.Clinical Trial Registration: NCT04713514 (ClinicalTrials.gov)."

Journal • Colorectal Cancer • Gynecologic Cancers • 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 | Not yet recruiting | Sponsor: OSE Immunotherapeutics

Checkpoint inhibition • Metastases • New P3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OSE Immunotherapeutics KOL Investor Webinar on the Therapeutic Landscape and Unmet Medical Needs in Non-Small Cell Lung Cancer by Dr Stephen Liu and Prof Benjamin Besse (GlobeNewswire) - "In this webinar, OSE Immunotherapeutics joins key opinion leaders Dr Stephen Liu, associate professor and director of Thoracic Oncology at Georgetown University Lombardi Comprehensive Cancer Center (Washington DC, United States) and Prof Benjamin Besse, medical oncologist and director of clinical research at the Gustave Roussy Institute (Villejuif, France), to discuss the current unmet medical needs in lung cancer therapeutics and the development landscape of OSE Immunotherapeutics therapeutic cancer vaccine, Tedopi."

Clinical • Lung Cancer • Oncology • Solid Tumor

Randomized Phase 3 Positive Results with OSE2101, an off-the-Shelf CD8 Neoepitopes Therapeutic Cancer Vaccine (IO-SUMMIT EUROPE 2024) - "The neoepitopes cancer vaccine OSE2101 has been optimised to break self-tolerance against tumour-associated antigens by increasing affinity for TCR/HLA interactions. The presentation highlights the positive phase 3 results of OSE2101 evaluated in monotherapy versus chemotherapy in advanced non-small-cell lung cancer patients who progress after immune checkpoint blockade: - Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi versus 27.5% with chemotherapy- Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy- Significant better quality-of-life (Global health status: p=0.045; Role Functioning: p=0.025)."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

OSE Immunotherapeutics Receives €8.4 M in Public Funding to Support the Registration Phase 3 Clinical Trial of Cancer Vaccine Tedopi in Lung Cancer (GlobeNewswire) - "OSE Immunotherapeutics SA...announced the Company has received €8.4 million in non-dilutive funding under the 'i-Démo' call for projects as part of the plan 'France 2030' operated by Bpifrance on behalf of the State....This public funding will support the registration Phase 3 clinical trial of neoepitope-based cancer vaccine Tedopi, in second line treatment in HLA-A2 positive non-small cell lung patients with secondary (acquired) resistance to anti-PD-(L)1 immunotherapy....The clinical trial application dossier to initiate the new confirmatory Phase 3 of Tedopi, including the study protocol and the specific 'diagnostic companion test' dossier, was approved by the Food & Drug Administration (FDA) in mid-January 2024, which should allow the trial to start in the United States in Q2 2024, after approval from the Ethic committees."

Financing • IND • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Therapeutic vaccines for advanced non-small cell lung cancer. (PubMed, Cochrane Database Syst Rev) - "Adding a vaccine resulted in no differences in overall survival, except for racotumomab, which showed some improvement compared to placebo, but the difference in median survival time was very small (1.4 months) and the study only included 176 participants. Regarding progression-free survival, we observed no differences between the compared treatments, except for TG4010, which may increase progression-free survival slightly. There were no differences between the compared treatments in serious treatment-related adverse events, except for SRL172 (killed Mycobacterium vaccae) added to chemotherapy, which was associated with an increase in the proportion of participants with at least one serious treatment-related adverse event, and OSE2101, which may decrease slightly the proportion of people having at least one serious treatment-related adverse event. These conclusions should be interpreted cautiously, as the very low- to moderate-certainty evidence prevents drawing solid ..."

Journal • Metastases • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Randomized Phase 3 Positive Results with OSE2101, an off-the-Shelf CD8 Neoepitopes Therapeutic Cancer Vaccine (IO-SUMMIT EUROPE 2024) - "The neoepitopes cancer vaccine OSE2101 has been optimised to break self-tolerance against tumour-associated antigens by increasing affinity for TCR/HLA interactions. The presentation highlights the positive phase 3 results of OSE2101 evaluated in monotherapy versus chemotherapy in advanced non-small-cell lung cancer patients who progress after immune checkpoint blockade: - Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi versus 27.5% with chemotherapy- Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy- Significant better quality-of-life (Global health status: p=0.045; Role Functioning: p=0.025)."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

ATALANTE 1: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure (clinicaltrials.gov) - P3 | N=219 | Terminated | Sponsor: OSE Immunotherapeutics | N=363 ➔ 219 | Active, not recruiting ➔ Terminated; due to COVID-19

Checkpoint inhibition • Enrollment change • Metastases • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TEDOVA: OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: ARCAGY/ GINECO GROUP | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Combination therapy • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

OSE Immunotherapeutics Announces a Collaboration Agreement with GenDx for the Development of a Companion Diagnostic for Epitope-Based Cancer Vaccine Candidate Tedopi (Businesswire) - "OSE Immunotherapeutics SA...today announced that the Company has entered into a collaboration with GenDx (a Eurobio Scientific Company, a key player in the field of specialty in vitro diagnostics) to develop and validate a companion diagnostic (CDx) test to support the confirmatory pivotal Phase 3 clinical trial of Tedopi cancer vaccine candidate in preparation in Non-Small Cell Lung Cancer (NSCLC) second line treatment....Under the Master Collaboration Agreement, GenDx will develop and validate a companion diagnostic (CDx) unique test for a predictive immunological biomarker to identify patients with HLA-A*02 genotype (1) who are biological responders to Tedopi epitopes."

Diagnostic • Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Modified-epitope-based vaccine (OSE2101) combined with anti-PD-1/IL-7v bispecific antibody sustains long-lasting tumor specific antigen memory T cell response in vivo (SITC 2023) - "In A2DR1 immunogenicity model, the combination of OSE2101 + anti PD-1/IL7v treatment demonstrates significant higher peripheral, and lung resident tumor-specific-CTL response was observed as measured by IFNγ ex-vivo restimulation in both short-term or long-term models suggesting that Anti-PD-1 IL7v enhances OSE201 efficacy by favoring memory tumor-specific T cell. Conclusions Our preclinical data support the potential benefit of combining modified-epitope-based Tedopi vaccine OSE2101 and anti-PD-1/IL7v immunocytokine to enhance magnitude and long-term maintenance of clonal anti-tumor-specific T cells."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • IFNG • IL7

OSE Immunotherapeutics Announces H1 2023 Results and Provides Corporate Update (Businesswire) - "(i) Tedopi® (T-cell specific immunotherapy - cancer vaccine): Based on final results of positive data on survival, safety and quality of life from the first Phase 3 trial in 3rd line in non-small cell lung cancer...confirmatory Phase 3 in preparation for 2024 in 2nd line, combined with a strategy of unique companion diagnostic development. Completion of patient enrollment in the Phase 2 in pancreatic cancer announced in May 2023, clinical readout expected in 2024....(ii) OSE-279, proprietary PD1 antagonist:...First clinical data will be presented at AACR-NCI-EORTC (Boston, 11 – 15th October 2023)."

New P3 trial • P1 data • P2 data • Lymphoma • Non Small Cell Lung Cancer • Pancreatic Cancer