A randomised, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with secondary resistance to Immune Checkpoint Inhibitor - ARTEMIA study - OSE2101C302

Start Date03 Dec 2024

Sponsor / Collaborator

OSE Immunotherapeutics SA

NCT06472245

/ RecruitingPhase 3

A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Start Date03 Dec 2024

Sponsor / Collaborator

OSE Immunotherapeutics SA

[+2]

NL-OMON57031

/ SuspendedPhase 3

Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA) - Use of GenDx CDx Tedopi for enrollment in OSE2101C302 (ARTEMIA study)

Start Date20 May 2024

Sponsor / Collaborator-

100 Clinical Results associated with EP-2101

100 Translational Medicine associated with EP-2101

100 Patents (Medical) associated with EP-2101

Literatures (Medical) associated with EP-2101

01 May 2025·LUNG CANCER

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

Article

Author: Viteri, S ; Vandewalle, T ; Vasseur, B ; Cappuzzo, F ; Dziadziuszko, R ; Liu, S V ; Remon, J ; Chevalier, C ; Gabarre, V ; Comis, S ; Montestruc, F ; Besse, B

07 Nov 2024·Future Oncology

TEDOVA: vaccine OSE2101 +/- pembrolizumab as maintenance in platinum-sensitive recurrent ovarian cancer

Article

Author: Angelergues, Antoine ; Lebreton, Coriolan ; Kaczmarek, Emilie ; Frenel, Jean-Sébastien ; Sabatier, Renaud ; Paoletti, Xavier ; Welz, Julia ; Gladieff, Laurence ; Grellety, Thomas ; Favier, Laure ; Kabirian, Rayan ; Eberst, Lauriane ; Van Gorp, Toon ; Mansi, Laura ; De La Motte Rouge, Thibault ; Tredan, Olivier ; Fabbro, Michel ; Marmé, Frederik ; Alexandre, Jérôme ; Leary, Alexandra

Ovarian cancer is a leading cause of death from gynecological cancers worldwide. Platinum-based chemotherapy provides the cornerstone of the medical management. In first line and subsequent relapses, maintenance strategies are offered to prolong intervals between lines of chemotherapy. Current maintenance options involve bevacizumab and poly ADP-ribose polymerase inhibitors, but these lines of therapy can only be used once in the disease course. 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).

01 Oct 2023·Annals of oncology : official journal of the European Society for Medical Oncology

Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1

Article

Author: Delclaux, B. ; Dziadziuszko, R. ; Maio, M. ; Zalcman, G. ; Romano, G. ; Cadranel, J. ; Costantini, D. ; Roch, B. ; Madroszyk, A. ; Sanborn, R. ; Panikkar, R. ; Tonini, G. ; Urban, L. ; Remon, J. ; Pichon, E. ; Masson, P. ; Felip, E. ; Ginoux, M. ; Schmidtke-Schrezenmeier, G. ; Gottfried, M. ; Tassinari, D. ; Garcia Campelo, M.R. ; Debieuvre, D. ; Zer, A. ; Dasgupta, A. ; Robinet, G. ; Chouaid, C. ; Garcia Campelo, R. ; Minotti, V. ; Bonnet, C. ; Ferrand, F.R. ; Denis, F. ; Razaq, M. ; Cobo, M. ; Provencio, M. ; Bonanno, L. ; Rea, A. ; Moran, T. ; Molinier, O. ; Mascaux, C. ; Liu, S. ; Oubre, D. ; Gabrail, N. ; Hernández, A. ; Galetta, D. ; Szczęsna, A. ; De Castro, J. ; Zemanová, M. ; Besse, B. ; Schuette, W. ; Wollner, M. ; Cortot, A. ; Delmonte, A. ; Bonetti, A. ; Giaccone, G. ; Duchemann, B. ; Moro-Sibilot, D. ; Vasseur, B. ; Nechushtan, H. ; Baldini, E. ; Karaszewska, B. ; Harshad, A. ; Mazieres, J. ; El Kouri, C. ; Hilgers, W. ; Cappuzzo, F. ; Viteri, S. ; Peled, N.

BACKGROUND:

Patients with advanced non-small-cell lung cancer (NSCLC) treated with immune checkpoint blockers (ICBs) ultimately progress either rapidly (primary resistance) or after durable benefit (secondary resistance). The cancer vaccine OSE2101 may invigorate antitumor-specific immune responses after ICB failure. The objective of ATALANTE-1 was to evaluate its efficacy and safety in these patients.

PATIENTS AND METHODS:

ATALANTE-1 was a two-step open-label study to evaluate the efficacy and safety of OSE2101 compared to standard-of-care (SoC) chemotherapy (CT). Patients with human leukocyte antigen (HLA)-A2-positive advanced NSCLC without actionable alterations, failing sequential or concurrent CT and ICB were randomized (2 : 1) to OSE2101 or SoC (docetaxel or pemetrexed). Primary endpoint was overall survival (OS). Interim OS futility analysis was planned as per Fleming design. In April 2020 at the time of interim analysis, a decision was taken to prematurely stop the accrual due to coronavirus disease 2019 (COVID-19). Final analysis was carried out in all patients and in the subgroup of patients with ICB secondary resistance defined as failure after ICB monotherapy second line ≥12 weeks.

RESULTS:

Two hundred and nineteen patients were randomized (139 OSE2101, 80 SoC); 118 had secondary resistance to sequential ICB. Overall, median OS non-significantly favored OSE2101 over SoC {hazard ratio (HR) [95% confidence interval (CI)] 0.86 [0.62-1.19], P = 0.36}. In the secondary resistance subgroup, OSE2101 significantly improved median OS versus SoC [11.1 versus 7.5 months; HR (95% CI) 0.59 (0.38-0.91), P = 0.017], and significantly improved post-progression survival (HR 0.46, P = 0.004), time to Eastern Cooperative Oncology Group (ECOG) performance status deterioration (HR 0.43, P = 0.006) and Quality of Life Questionnaire Core 30 (QLQ-C30) global health status compared to SoC (P = 0.045). Six-month disease control rates and progression-free survival were similar between groups. Grade ≥3 adverse effects occurred in 11.4% of patients with OSE2101 and 35.1% in SoC (P = 0.002).

CONCLUSIONS:

In HLA-A2-positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to CT. Further evaluation in this population is warranted.

News (Medical) associated with EP-2101

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPriority Review

13 Dec 2024

·www.globenewswire.com

OSE Immunotherapeutics Announces Positive Clinical Progress for Late-Stage Proprietary Cancer Vaccine Tedopi®

OSE Immunotherapeutics Announces Positive Clinical Progress for Late-Stage Proprietary Cancer Vaccine Tedopi® 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. 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. December 11, 2024 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided a clinical update on Tedopi® (OSE-2101), the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, under evaluation in a range of cancer indications where there is large unmet medical need. Silvia Comis, MD, Head of Clinical Development and Regulatory Affairs, OSE Immunotherapeutics said: “Tedopi® is currently being evaluated in monotherapy and in combination through four clinical trials and three cancer indications. Not only is the clinical program fully on track, but our progress highlights the potential to address diverse medical needs. This ‘pipeline in a product’ approach underscores our commitment to bringing innovative solutions to patients who need them most. The enrollment of the first patients this year in Artemia, our global Phase 3 registration study signifies a pivotal milestone, advancing us towards the final phase before the registration of Tedopi® for the treatment of NSCLC. Enrollment has also been completed in the combination Phase 2 trial, TEDOVA, in ovarian cancer and we are nudging towards completion of patient enrollment for the Phase 2 study in NSCLC. For both TEDOVA and CombiTED we are expecting readouts in 2026. Finally, we can expect the Phase 2 readouts for the study TEDOPaM in pancreatic cancer early next year.” Dr Alexandra Leary, M.D., Ph.D., Chief Investigator of TEDOVA study from Gustave Roussy cancer center, comments: “We are very grateful to the investigators and to the patients involved in TEDOVA for this key clinical achievement. This is the first trial evaluating an innovative maintenance strategy for patients with ovarian cancer in relapse post-bevacizumab and PARP inhibitors, a patient population which does not respond to checkpoint inhibitors alone, and which urgently needs novel maintenance strategies to prolong chemotherapy-free intervals. We now look forward to the study’s results to confirm the potential of Tedopi® as a novel maintenance therapy for these women.” TEDOVA is a two-arm Phase 2 study evaluating Tedopi® as a maintenance treatment, alone or in combination with anti-PD-1 immune checkpoint inhibitor Keytruda® (pembrolizumab) versus best supportive care in patients with first or second platinum-sensitive recurrent ovarian cancer with controlled disease after platinum-based chemotherapy who have already received both bevacizumab and a PARP (Poly ADP-Ribose Polymerase) inhibitor. The primary criterion is to evaluate the benefit by the Progression Free Survival (PFS) of the maintenance of Tedopi® alone or in combination with a PD1 inhibitor after platinum-based chemotherapy in relapsed ovarian cancer. A total of 180 patients were included in the trial and the readouts are expected in Q2 2026 (NCT04713514, sponsor: ARCAGY-GINECO). CombiTED is a three-arm Phase 2 study evaluating Tedopi® in combination with anti-PD1 immune checkpoint inhibitor Opdivo® (nivolumab) or Tedopi® plus chemotherapy or chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy. A total of 105 patients are planned for the trial and enrollment completion is expected in Q1 2025. The readouts are expected in H2 2026 (NCT04884282, sponsor: FoRT). TEDOPaM is a non-comparative Phase 2 trial evaluating Tedopi® plus FOLFIRI chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after eight cycles of FOLFIRINOX induction chemotherapy. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis ≤25%; alternative hypothesis ≥ 50%), and the key secondary endpoint is the progression-free survival. A total of 136 patients were recruited in the Phase 2 trial and readouts are expected in H1 2025 (NCT03806309, sponsor: GERCOR). OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyVaccine

17 Oct 2024

·www.globenewswire.com

OSE Immunotherapeutics Presents New “Cis-Demasking” Bispecific Technology for the Design of Cytokine Drugs with Improved Therapeutic Index

NANTES, France, October 17, 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced it will be presenting its novel OSE-CYTOMASK Cis-Demasking1 cytokine technology in oral presentations selected for international conferences: The Festival of Biologics in Basel, Switzerland (October 17, 2024)The 16th Annual Protein & Antibody Engineering Summit (PEGS) Europe Summit in Barcelona, Spain (November 7, 2024)The Antibody Therapeutics Xchange in Brussels (November 18, 2024) OSE-CYTOMASK is an innovative proprietary non-cleavable linker technology to create a new class of regulated and targeted cytokine therapeutics that deliver highly active medicines with improved therapeutic index. The presentations highlight the rational design of the technology through two first preclinical programs based on anti-PD1 masked cytokine (IL-2, IL-15) in oncology with conditional Cis-Demasking and Cis-Potentiation of tumor-specific T cells expressing PD1 or other immune targets. Aurore Morello, Head of Research, OSE Immunotherapeutics, said: “We are very happy to present our novel OSE-CYTOMASK technology at upcoming leading scientific conferences. Our novel linker technology allows conditional Cis-Demasking of cytokine, through PD1-targeting on tumor-specific T cells, without relying on protease-cleavable technology or mutagenesis of cytokine to abrogate off-tumor activity associated with significant toxicity of the majority of cytokines from this class of drugs. The high preclinical efficacy observed in monotherapy and good tolerance profile of the first two drug candidates selected open the way to a potential novel first-in-class treatment for patients in high need of new therapeutic options in oncology.” Nicolas Poirier, Chief Executive Officer, OSE Immunotherapeutics, adds: “We are proud of the achievements from our research team on the advancement of these programs. This highly innovative technology promises to unleash the full potential of cytokines in oncology by dramatically increasing the therapeutic index of this class of drugs. We are also interested in potential applications of this innovative technology in autoimmune and inflammatory diseases.” Immunostimulatory cytokines are a highly potent class of drug to reactivate the immune system against tumors. Their narrow therapeutic index is associated with significant peripheral toxicity and limited drug exposure in the tumor microenvironment (TME), limiting their clinical development. Current conditional cytokine masking approaches relying on theoretical demasking activity in the TME with cleavable linker technologies by enzymes produce more selectively by the tumors have already demonstrated their limitation due to the heterogenous protease expression in tumors (variable on-tumor activation across patients) and non-specific protease expression in non-tumor sites (off-tumor cytokine activity). We have engineered an innovative non-cleavable recombinant linker technology allowing specific conditional delivery of cytokine activity only where needed based on an original targeted Cis-Demasking mechanism independent of proteases expression. OSE-CYTOMASK technology has been used first to implement our proprietary anti-PD1 BiCKI® platform in order to improve the therapeutic index of highly active cytokines (eg., IL-2, IL-15…). The Company presented two first preclinical programs with anti-PD1/masked IL-2 and anti PD1/masked IL-15 with robust preclinical efficacy demonstrated in monotherapy leading to a high rate of anti-tumor response and eradication in different models (eg. orthotopic pancreatic tumor, melanoma or colon cancer) in the absence of peripheral toxicity in dose-response illustrating significantly improved therapeutic index of both IL-2 or IL-15 using the OSE-CYTOMASK technology. Presentations: details Festival of Biologics (October 17), BaselPresenter: Aurore Morello, PhD., Head of Research, OSE Immunotherapeutics“OSE- Cytomask Technology: Cis-Demasking Cytokine Technology for targeted Delivery”October 17, 11:30 Protein & Antibody Engineering Summit (PEGS) Europe Summit (November 7), Barcelona Presenter: Nicolas Poirier, PhD, Chief Executive Officer, OSE Immunotherapeutics“OSE-CYTOMASK: Cis-Demasking Cytokine Technology with Non-Cleavable Linker”November 7, 16:40 Antibody Therapeutics Xchange (November 18), Brussels Presenter: Aurore Morello, PhD., Head of Research, OSE Immunotherapeutics“Addressing challenges faced for optimal bi-specific and Immunocytokines engineering” November 18, 09:05 - 10:05 About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): most advanced therapeutic cancer vaccine in development; positive results from a randomized Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in third-line secondary resistance after checkpoint inhibitor failure. Ongoing randomized registration Phase 3 study (Artemia) in second-line NSCLC in HLA-A2+ patients with secondary resistance. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-127 - Lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); Positive Phase 2 (CoTikiS) study in Ulcerative Colitis; ongoing preclinical research in leukemia. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.).Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic diseases (CRM); positive Phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases planned to be initiated end of 2024.ABBV-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. ABBV-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs.Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs.BiCKI® Platform is a bifunctional fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy by “cis-potentiating” tumor-specific T cells. A first program has been acquired by Boehringer Ingelheim. OSE-CYTOMASK is an innovative technology to create cytokine therapeutics with improved therapeutic index.mRNA Therapeutic platform allows local delivery into the inflammatory site of innovative immunotherapies encoded by RNA to locally controls and/or suppress immune responses and inflammation. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Sylvie Détrysylvie.detry@ose-immuno.comNicolas PoirierChief Executive Officer nicolas.poirier@ose-immuno.comFrench Media: FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooneyPartners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis 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 April 30, 2024, including the annual financial report for the fiscal year 2023, 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. 1 Cis-Demasking: Bispecific antibodies (*) have the capability to target cells either in a Cis- targeting (on the same cell) or in a Trans-binding orientation (between two different cells). Cis-Demasking bispecific technology targets two antigens expressed on the same cell, with one masked modality (eg. Cytokine) and enabling conditional activity of the cytokine on the desired immune cell types upon antibody binding. (*) Segués A. et al. International Review of Cell and Molecular Biology 2022. Attachment EN_241017_OSE CYTOMASK

ImmunotherapyClinical ResultPhase 3VaccinePhase 1

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Indication	Highest Phase	Country/Location	Organization	Date
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	United States	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Belgium	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Canada	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	France	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Greece	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Hungary	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Italy	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Netherlands	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Poland	OSE Immunotherapeutics SA	03 Dec 2024
HLA-A2 Positive Non-Small Cell Lung Cancer	Phase 3	Portugal	OSE Immunotherapeutics SA	03 Dec 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03806309 (TEDOPaM, NEWS) Manual	Phase 2	Pancreatic Ductal Adenocarcinoma HLA-A2阳性	-	OSE2101+FOLFIRI	vjuqxwwdrp(hkdbfmumzs) = 在研现货型癌症疫苗OSE2101在2期临床试验TEDOPaM中达到主要终点。 bhedylxzub (gvxgpgdznc ) Met View more	Positive	14 Mar 2025
				FOLFIRI
NCT02654587 (ATALANTE-1, Pubmed \| Ann Oncol)	Phase 3	Advanced Lung Non-Small Cell Carcinoma HLA-A2-positive	-	OSE2101	uitquipyml(vfupqndkvy): HR = 0.86 (95% CI, 0.62 - 1.19), P-Value = 0.36	Positive	01 Oct 2023
				Standard-of-care chemotherapy (docetaxel or pemetrexed)
NCT02654587 (ATALANTE-1, ASCO2023) Manual	Phase 3	Non-Small Cell Lung Cancer EGFR negative \| ALK negative	118	OSE2101 (PS deteriorated > 1)	dqqkwahyrb(xfymumennh) = yspbhrrjzp utsgvhlbup (mzvsbvlmza, 2.9 - 8.2)	Positive	31 May 2023
				Chemotherapy (docetaxel (PS ≤1)	dqqkwahyrb(xfymumennh) = ykiyjutzlo utsgvhlbup (mzvsbvlmza, 4.4 - 10.3)
NCT02654587 (Atalante-1, ESMO2022)	Phase 3	HLA-A2 Positive Non-Small Cell Lung Cancer	219	OSE2101	dyyqikphhg(hazdodupdc) = iglrdzmhrs mdolflkslh (kheypigjzf )	Positive	10 Sep 2022
NCT02654587 (Atalante-1, ESMO2022)	Phase 3	HLA-A2 Positive Non-Small Cell Lung Cancer	118	OSE2101	futtunaxzy(pbhdtyejnd) = efamvclniu hphswexeex (qiitkkkakh ) View more	Positive	10 Sep 2022
NCT02654587 (ASCO2022) Manual	Phase 3	HLA-A2 Positive Non-Small Cell Lung Cancer HLA-A2 Positive	95	OSE 2101	zmpvofheet(nwhigwquvm) = jrolheuqzg aerfqdhynu (ithjskwrju ) View more	Positive	02 Jun 2022
				SoC+Docetaxel+Pemetrexed Disodium Hydrate	zmpvofheet(nwhigwquvm) = azjwesckwt aerfqdhynu (ithjskwrju ) View more
NCT03806309 (TEDOPaM-PRODIGE 63, ASCO2022) Manual	Phase 2	Advanced Pancreatic Ductal Adenocarcinoma Maintenance	29	OSE2101	hjggjzczuo(otqgoqnjgh) = yfxdyazdhc xouccopdrq (dfupezuchz, 12.3 - 67.0) View more	Non-superior	02 Jun 2022
				OSE2101+nivolumab	hjggjzczuo(otqgoqnjgh) = czjqnwlljv xouccopdrq (dfupezuchz, 7.1 - 57.8) View more
NCT02654587 (ATALANTE-1, SITC2021)	Phase 3	Non-Small Cell Lung Cancer CEA \| HER2 \| MAGE2 ... View more	8	TedopiÂ®	onnmjugfmy(fdnyjxqjgn) = hvmneywxim poaqbkcdcr (mpeqvfomuo )	Positive	10 Nov 2021
NCT02654587 \| EUCTR2015-003183-36-CZ (ESMO 12021 \| ESMO 22021) Manual	Phase 3	HLA-A2 Positive Non-Small Cell Lung Cancer HLA-A2 Positive	219	OSE-2101	ktigynybke(lyrrxpjjzs) = ybadrjzufg pgdxtyxbri (cyixarvhrw ) View more	Positive	20 Sep 2021
				docetaxel or pemetrexed	ktigynybke(lyrrxpjjzs) = nuzrqetxrr pgdxtyxbri (cyixarvhrw ) View more
NCT02654587 (ATALANTE-1, ESMO2020)	Phase 3	HLA-A2 Positive Non-Small Cell Lung Cancer	99	Tedopi®	vpieywjkio(hypztwgbyj) = wljjvrgkvy llavpgctzc (bsiudknbcs, 33 - 59)	Positive	18 Sep 2020
				Standard treatment (docetaxel or pemetrexed)	vpieywjkio(hypztwgbyj) = fnzycbkefz llavpgctzc (bsiudknbcs, 21 - 54)

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