OSE-279 / OSE Immunotherapeutics - LARVOL DELTA

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

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: OSE Immunotherapeutics | Trial completion date: Dec 2024 ➔ Dec 2029 | Trial primary completion date: Oct 2024 ➔ Dec 2029

Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • MSI

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: OSE Immunotherapeutics | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Oct 2024

Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • MSI

OSE Immunotherapeutics Provides Update on Clinical Results With OSE-279 in Advanced Solid Tumors (Businesswire) - P1/2 | N=24 | NCT05751798 | Sponsor: OSE Immunotherapeutics | "OSE Immunotherapeutics SA...presented an update on the positive results of OSE-279 in the Phase 1/2 clinical evaluation in advanced solid tumors at the 2024 ESMO Targeted Anticancer Therapies Congress....The updated data show a good pharmacokinetic/pharmacodynamic (PK/PD) and manageable safety profile in line with previous anti-PD1 development and with a high signal of efficacy in the first 20 patients representing 13 different tumor types. Four confirmed ongoing partial responses (PR) with 600 mg every six weeks (q6w), with a response rate of 36%, were reported in patients with anal squamous cell carcinoma, undifferentiated pleomorphic sarcoma, oncocytic thyroid cancer, and alveolar soft part sarcoma."

P1/2 data • Alveolar Soft Tissue Sarcoma • Anal Carcinoma • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Undifferentiated Pleomorphic Sarcoma

OSE279, a PD-1-blocking monoclonal antibody, as future backbone of a bifunctional checkpoint inhibitor platform: Preliminary results of a first-in-human (FIH) study in subjects with advanced malignancies (ESMO-TAT 2024) - P1/2 | "PK and PD profiles were according to modelling. New cohorts testing combinations, including with cancer vaccine, are planned."

Checkpoint inhibition • Clinical • Metastases • P1 data • Anal Carcinoma • Gastrointestinal Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Undifferentiated Pleomorphic Sarcoma

OSE Immunotherapeutics Presents First Positive Clinical Results With its anti-PD1 OSE-279 in Advanced Solid Tumors (Businesswire) - P1/2 | N=24 | NCT05751798 | Sponsor: OSE Immunotherapeutics |"OSE Immunotherapeutics SA...presented the first Phase 1/2 positive clinical results with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors at the AACR-NCI-EORTC International Conference...(October 11 – 15, 2023 - Abstract number 35371, Poster C063)....These data have shown a manageable safety profile with preliminary signs of efficacy in the first 13 patients included with 8 tumor types and treated by a dose of 100 and 300 mg every 3 weeks (q3w) or 600 mg every 6 weeks (q6w). One confirmed partial response in a hepatocellular carcinoma patient (-81% tumor shrinkage) after a single dose of OSE-279 300 mg and 2 yet unconfirmed partial responses in anal squamous cell carcinoma (-46% tumor shrinkage) and undifferentiated pleomorphic sarcoma (-33% tumor shrinkage) with OSE-279 600 mg, were reported out of 11 patients with at least one post baseline tumor assessment."

P1/2 data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

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

OSE279, a PD-1 blocking monoclonal antibody, as future backbone of a bifunctional checkpoint inhibitor platform: Preclinical characterization and early clinical results of a First-In-Human (FIH) study in subjects with advanced malignancies. (AACR-NCI-EORTC 2023) - No abstract available

Checkpoint inhibition • Metastases • P1 data • Preclinical • Oncology

OSE Immunotherapeutics Reports Full Year 2022 Financial Results and Provides Business Strategy Update (Businesswire) - "A STRONG GLOBAL INTELLECTUAL PROPERTY STRATEGY: (i) OSE-172: Four patents (United States, Japan, Korea and ARIPO (Africa)) covering anti-SIRPα antibodies, until 2036-2037; (ii) OSE-279: Six patents (United States, Japan, Korea, China, Mexico and Colombia) for OSE-279 and its use in cancer treatment, until 2039; (iii) CLEC-1: Three patents (United States, Japan and Israel) covering CLEC-1, novel myeloid immune checkpoint target for cancer immunotherapy, until 2037."

Patent • Oncology

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

Metastases • New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • MSI

OSE Immunotherapeutics Announces First Patient Dosed with Anti-PD1 Monoclonal Antibody OSE-279 in a Phase 1/2 Clinical Trial in Advanced Solid Tumors or Lymphomas (Businesswire) - "OSE Immunotherapeutics SA...announced today that the first patient has been dosed in the Phase 1/2 clinical trial evaluating OSE-279, a high affinity anti-PD1 blocking monoclonal antibody, in patients with advanced solid tumors or lymphomas....This first-in-human open label Phase 1/2 dose escalation and expansion study aims to determine the Maximum Tolerated Dose and/or the recommended Phase 2 dose of OSE-279 as a monotherapy in advanced solid tumors or lymphomas."

Trial status • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor