What Is OSE2101?
OSE2101 is an investigational therapeutic cancer vaccine. It is designed to stimulate the body's immune system to recognize and fight cancer cells. Specifically, OSE2101 is a peptidic cancer vaccine made up of nine small protein fragments (epitopes) that target common tumor-associated antigens such as P53, HER-2, CEA, MAGE-2, and MAGE-3. These epitopes are restricted to the HLA-A2 genetic phenotype, meaning it is intended for patients with this specific immune marker. It also includes one pan-HLA DR binding epitope (PADRE) to broaden the immune response, all emulsified in an adjuvant called Montanide ISA 51TM to enhance its effectiveness.
Currently, OSE2101 is being studied in clinical trials for various types of cancer, including non-small cell lung cancer and ovarian cancer. There is no currently approved maintenance therapy for platinum-sensitive relapsed ovarian cancer after certain prior treatments, highlighting an urgent need for novel strategies like OSE2101 in this setting.
Uses and Conditions Under Study
OSE2101 is being investigated in clinical trials for several types of advanced cancers, with a total of 5 trials underway. These studies aim to determine its effectiveness and safety, sometimes in combination with other treatments.
- Non-Small Cell Lung Cancer (NSCLC): OSE2101 is being studied in patients with NSCLC, including those with locally advanced or metastatic disease. One trial specifically evaluated OSE2101 (TEDOPI) against standard chemotherapy in HLA-A2 positive patients with metastatic NSCLC who had progressed after prior treatments. This condition is being studied in 3 trials under various descriptions: Non Small Cell Lung Cancer, NSCLC (Non-small Cell Lung Cancer), and Patients With Non-Small Cell Lung Cancer.
- Ovarian Cancer: OSE2101 is also under investigation for ovarian cancer, particularly in cases of platinum-sensitive relapsed ovarian cancer. This type of cancer often requires new treatment options, especially after patients have received prior therapies. This condition is being studied in 2 trials: Platinum-sensitive Ovarian Cancer and Relapsed Ovarian Cancer.
- Other Advanced Cancers: OSE2101 is being explored for its potential in other advanced cancers. This includes conditions such as Locally Advanced Cancer, Metastatic Cancer, and Solid Advanced Tumor, each representing a broad category of cancers that have spread or are difficult to treat with standard therapies. Each of these specific conditions is being studied in 1 trial.
- Lymphoma and Pancreatic Ductal Adenocarcinoma: The drug is also being studied in 1 trial for Lymphoma, a cancer of the immune system, and in 1 trial for Pancreatic Ductal Adenocarcinoma, an aggressive form of pancreatic cancer.
Dosing
OSE2101 is administered as a subcutaneous injection, meaning it is injected under the skin. The investigational dosing schedule described in one trial involves an initial injection on day 1, followed by injections every 3 weeks for a total of 7 doses. After this initial phase, the frequency may decrease to every 6 weeks up to week 48, and then every 12 weeks. Treatment continues until disease progression, intolerance, or for up to 2 years, whichever comes first.
In clinical trials, OSE2101 has been studied as a standalone treatment and in combination with other therapies. For example, it has been investigated in combination with OSE-279, a human IgG4 monoclonal antibody against PD-1, at various doses of OSE-279 (100 mg, 300 mg, or 600 mg). OSE2101 has also been studied alongside pembrolizumab and with FOLFIRI (a chemotherapy regimen including folinic acid, irinotecan, and 5-FU) as a maintenance therapy. Another trial compared OSE2101 (TEDOPI) to standard chemotherapy options like docetaxel or pemetrexed.
Side Effects
Information regarding specific side effects for OSE2101 from the provided clinical trial data is not available in this summary.
Clinical Trial Results
Results for OSE2101 come from a completed Phase 3 study (NCT02654587) that compared OSE2101 to standard chemotherapy (docetaxel or pemetrexed) in patients with advanced non-small cell lung cancer (NSCLC) who were HLA-A2 positive and had previously failed immune checkpoint inhibitor therapy.
Overall Survival and Disease Control
- Patients treated with OSE2101 had a median overall survival of 11.1 months, compared to 7.5 months for those receiving chemotherapy.
- The disease control rate at 6 months was similar between the groups, with 24.7% of patients on OSE2101 achieving disease control compared to 23.7% on chemotherapy.
- For objective response at 6 months, 33.3% of patients on OSE2101 showed an objective response, compared to 26.8% on chemotherapy. The overall objective response rate (ORR) during the study was 7.7% for OSE2101 and 18.4% for chemotherapy.
- Median progression-free survival was 2.69 months for OSE2101 and 2.99 months for chemotherapy.
- Post-progression survival was longer for patients on OSE2101, with a median of 7.7 months compared to 4.6 months for chemotherapy.
Quality of Life and Functional Status
- Patients treated with OSE2101 experienced a significantly longer time to worsening of their ECOG Performance Status (a measure of functional ability), with a median of 9.0 months compared to 3.3 months for those on chemotherapy. This suggests that OSE2101 may help maintain a patient's functional status for a longer period.
- Assessments using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and Lung Cancer Module (QLQ-LC13) showed that functional subscales generally worsened less, or even improved in some areas, for patients on OSE2101 compared to chemotherapy. For instance, functional scores for OSE2101 showed changes like 0.50 and 0.77 (indicating improvement), while chemotherapy scores generally showed worsening (e.g., -10.43, -16.78).
- Similarly, symptom subscales from these questionnaires indicated that patients on OSE2101 generally experienced less worsening of symptoms, and in some cases, improvement, compared to those on chemotherapy. For example, OSE2101 showed symptom score changes like -4.12 and -5.57 (indicating symptom reduction), while chemotherapy often showed increases in symptom scores (e.g., 5.82, 11.95).
Currently Recruiting Trials
OSE2101 is currently being investigated in clinical trials for various cancer types. These studies aim to evaluate its potential as a therapeutic option for patients.
One significant study, NCT06472245, is a Phase 3 trial sponsored by OSE Immunotherapeutics. This multicenter, randomized, open-label study is designed for patients with non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors. Participants must be HLA-A2 positive and have squamous or non-squamous metastatic NSCLC. The trial plans to enroll 363 patients, randomizing them into two arms: an experimental arm receiving OSE2101 monotherapy, and a control arm receiving standard of care docetaxel.
Another ongoing study, NCT05751798, is a Phase 1/2 dose-finding and dose expansion trial. This study investigates OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas. For certain parts of the study, OSE-279 is administered in combination with OSE2101, specifically for HLA-A2 positive participants. The trial is designed to enroll 41 subjects and is sponsored by OSE Immunotherapeutics.
Where to Participate
Clinical trials for OSE2101 are actively recruiting across 16 states, with a total of 79 sites located in 59 cities. This broad geographic reach aims to make participation accessible to more individuals.
Top participating locations include:
- Nashville, Tennessee (8 sites)
- Jacksonville, Florida (5 sites)
- Chattanooga, Tennessee (4 sites)
- Los Angeles, California (2 sites)
- The Bronx, New York (2 sites)
- St. Petersburg, Florida (2 sites)
Eligibility criteria for these trials specify that participants must be between 18 and 18 years old. The studies are open to all genders. Healthy volunteers and children are not eligible to participate in these specific trials.
Development Timeline
The development journey for OSE2101 began on January 13, 2016, with its first clinical trial. Since then, the drug has progressed through various stages of research, with the latest trial initiated on June 25, 2024. The primary sponsor driving the development of OSE2101 has been OSE Immunotherapeutics, with additional collaborative efforts from groups such as ARCAGY/GINECO GROUP and GERCOR - Multidisciplinary Oncology Cooperative Group.
Across its development, OSE2101 has been investigated in 5 clinical trials, enrolling a total of 909 participants. These studies have included one Phase 1/2 trial, two Phase 2 trials, and two Phase 3 trials, demonstrating a clear progression through the clinical development pipeline.
The initial focus of OSE2101's development included conditions such as IBS-C and hyperphosphatemia. Over time, the research expanded significantly into various cancer types, including Metastatic Cancer, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, and Ovarian Cancer, reflecting a strategic shift towards oncology indications.