#1 Clinical Trials Search in Europe

D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala

This article summarizes several clinical trials investigating the use of OSE2101 (TEDOPI), an innovative cancer vaccine, in treating various advanced cancers. OSE2101 contains multiple synthetic peptides designed to stimulate the immune system to target cancer cells. The trials are evaluating OSE2101 alone or in combination with other therapies for cancers including non-small cell lung cancer, ovarian cancer, and pancreatic cancer. These studies aim to assess the safety and efficacy of OSE2101 in improving outcomes for patients with difficult-to-treat advanced cancers.

Table of Contents

Overview

D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, also known as MPS-7 or aKXVAAWTLKAAa, is an investigational cancer vaccine being developed by OSE Immunotherapeutics[1]. It is one of the active components in a therapeutic cancer vaccine called TEDOPI (OSE2101)[2]. This vaccine is designed to stimulate the immune system to fight against certain types of cancer cells.

Mechanism of Action

TEDOPI, which contains D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, is a neo-epitope-based vaccine. Neo-epitopes are small protein fragments specific to cancer cells that can be recognized by the immune system. By introducing these cancer-specific epitopes, the vaccine aims to “train” the patient’s immune system to identify and attack cancer cells more effectively[3].

Potential Indications

Based on the clinical trials information, TEDOPI is being investigated for several types of cancer:

  • Non-Small Cell Lung Cancer (NSCLC): Particularly in patients with metastatic NSCLC who have developed resistance to immune checkpoint inhibitors[1].
  • Ovarian Cancer: As a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer[2].
  • Pancreatic Cancer: For patients with locally advanced or metastatic pancreatic ductal adenocarcinoma[4].

Administration

TEDOPI is administered as an emulsion for injection, typically given through subcutaneous injection. The dosage and frequency may vary depending on the specific clinical trial and cancer type being treated[1][2][4].

Clinical Trials

Several clinical trials are currently evaluating the efficacy and safety of TEDOPI:

  • ARTEMIA Study (Phase 3): Comparing TEDOPI to docetaxel in patients with metastatic NSCLC who have developed resistance to immune checkpoint inhibitors[1].
  • TEDOVA Study (Phase 2): Evaluating TEDOPI alone or in combination with pembrolizumab as a maintenance treatment for recurrent ovarian cancer[2].
  • TEDOPAM Study (Phase 2): Assessing TEDOPI in combination with FOLFIRI chemotherapy for patients with advanced pancreatic cancer[4].

Safety Profile

As with any investigational treatment, the full safety profile of TEDOPI is still being established through clinical trials. Some potential side effects and safety considerations include:

  • Immune-related adverse events (imAEs), which are being closely monitored in the trials[2].
  • Patients with a history of autoimmune diseases or who require systemic immunosuppressive treatments are typically excluded from the trials, suggesting potential risks for these populations[2][4].
  • Common side effects of cancer vaccines may include injection site reactions, fatigue, and flu-like symptoms.

Future Directions

The ongoing clinical trials will provide crucial data on the efficacy and safety of TEDOPI in various cancer types. If successful, this cancer vaccine could offer a new treatment option for patients who have limited alternatives, particularly those who have developed resistance to other immunotherapies[1][2][4].

Researchers are also exploring potential biomarkers that may predict which patients are most likely to benefit from TEDOPI treatment. This could lead to more personalized approaches in cancer immunotherapy[4].

Trial Name Cancer Type Treatment Primary Endpoint
ARTEMIA Metastatic Non-Small Cell Lung Cancer OSE2101 vs. docetaxel Overall Survival
OSE-279 Combination Advanced Solid Tumors or Lymphomas OSE-279 (PD-1 inhibitor) +/- OSE2101 Safety, Tolerability, Antitumor Activity
TEDOVA Recurrent Ovarian Cancer OSE2101 +/- pembrolizumab vs. best supportive care Progression-Free Survival
TEDOPAM Advanced Pancreatic Cancer OSE2101 + FOLFIRI vs. FOLFIRI alone Overall Survival at 12 months

FAQ

  • What is OSE2101 (TEDOPI)? OSE2101, also known as TEDOPI, is a cancer vaccine containing multiple synthetic peptides designed to stimulate the immune system to target and attack cancer cells. It is being investigated as a potential treatment for various advanced cancers.
  • What types of cancer are being studied with OSE2101? The clinical trials are evaluating OSE2101 for several types of advanced cancers, including non-small cell lung cancer (NSCLC), ovarian cancer, and pancreatic cancer.
  • How is OSE2101 administered? OSE2101 is administered as a subcutaneous injection or emulsion for injection, typically given at regular intervals over the course of treatment.
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety and efficacy of OSE2101, either alone or in combination with other therapies. They aim to evaluate outcomes such as overall survival, progression-free survival, and tumor response rates in patients with advanced cancers.
  • Who is eligible to participate in these trials? Eligibility varies by trial, but generally includes adult patients with specific advanced cancers, adequate organ function, and particular genetic markers like HLA-A2 positive status. Patients must meet certain criteria regarding prior treatments and overall health status.

Ongoing Clinical Trials on D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala

  • Study on Cemiplimab and OSE2101 for Maintenance Therapy in Patients with ctDNA Positive Non-Small Cell Lung Cancer (NSCLC)

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Tedopi and Nivolumab for Patients with Advanced Non-Small Cell Lung Cancer After Initial Treatment

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study Comparing OSE2101 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Immunotherapy Resistance

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France Germany Greece Hungary Italy +5

  • Study of OSE-279 and OSE2101 Drug Combination for Patients with Advanced Solid Tumors, Lymphomas, or Metastatic Non-Small Cell Lung Cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study on Maintenance Therapy with OSE2101 and FOLFIRI for Patients with Advanced Pancreatic Cancer After Initial FOLFIRINOX Treatment

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of OSE2101 vaccine alone or with pembrolizumab as maintenance therapy for patients with platinum-sensitive recurrent ovarian cancer after chemotherapy

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany

Glossary

  • OSE2101 (TEDOPI): A cancer vaccine containing multiple synthetic peptides designed to stimulate the immune system to target cancer cells. It is being investigated as a treatment for various advanced cancers.
  • HLA-A2: A specific type of human leukocyte antigen (HLA) that plays a role in the immune system's ability to recognize and respond to foreign substances or abnormal cells. Many of the trials require patients to be HLA-A2 positive.
  • NSCLC: Non-small cell lung cancer, a type of lung cancer that is being studied in some of the OSE2101 trials.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive. This is a key measure of effectiveness in cancer trials.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening. This is another important measure in cancer trials.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Immune Checkpoint Inhibitor (ICI): A type of immunotherapy drug that blocks certain proteins made by immune system cells, such as PD-1, PD-L1, and CTLA-4, to help the immune system kill cancer cells more effectively.
  • FOLFIRINOX: A combination chemotherapy regimen used to treat pancreatic cancer, consisting of folinic acid, fluorouracil, irinotecan, and oxaliplatin.
  • Sarcopenia: A condition characterized by loss of skeletal muscle mass and function, often associated with aging or chronic diseases like cancer.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that can be measured to indicate a normal or abnormal process, condition, or disease.

References

  1. http://clinicaltrials.eu/trial/study-comparing-ose2101-and-docetaxel-for-patients-with-metastatic-non-small-cell-lung-cancer-after-immunotherapy-resistance/
  2. http://clinicaltrials.eu/trial/study-of-maintenance-treatments-with-ose2101-and-pembrolizumab-for-patients-with-recurrent-ovarian-cancer-after-platinum-based-chemotherapy/
  3. http://clinicaltrials.eu/trial/study-of-ose-279-and-ose2101-drug-combination-for-patients-with-advanced-solid-tumors-lymphomas-or-metastatic-non-small-cell-lung-cancer/
  4. http://clinicaltrials.eu/trial/study-on-maintenance-therapy-with-ose2101-and-folfiri-for-patients-with-advanced-pancreatic-cancer-after-initial-folfirinox-treatment/