#1 Clinical Trials Search in Europe

Omp65

This article explores the clinical trials of EO2463, an innovative cancer vaccine therapy being studied for the treatment of indolent Non-Hodgkin’s Lymphoma, specifically Follicular Lymphoma and Marginal Zone Lymphoma. The trials aim to evaluate the safety, efficacy, and potential combinations of EO2463 with other treatments in both newly diagnosed and previously treated patients.

Table of Contents

What is EO2463?

EO2463 is a new type of cancer treatment called a microbial-derived peptide therapeutic vaccine. It is currently being studied for the treatment of certain types of indolent Non-Hodgkin’s Lymphoma (NHL), which are slow-growing blood cancers affecting the lymphatic system[1]. This innovative therapy is designed to stimulate the immune system to fight cancer cells.

Target Conditions

EO2463 is being investigated for the treatment of two specific types of indolent Non-Hodgkin’s Lymphoma:

  • Follicular Lymphoma (FL): A common type of slow-growing lymphoma that develops from B-lymphocytes (B-cells).
  • Marginal Zone Lymphoma (MZL): A group of lymphomas that also develop from B-cells. This includes three subtypes:
    • Extranodal MZL (EMZL, also known as MALT lymphoma)
    • Splenic MZL (SMZL)
    • Nodal MZL (NMZL)

These lymphomas are considered “indolent” because they tend to grow and spread slowly compared to more aggressive forms of lymphoma[1].

How EO2463 Works

EO2463 is composed of several peptides (small protein fragments) derived from microbes. These peptides are:

  • OMP72
  • OMP64
  • OMP65
  • OMP66
  • UCP2

These peptides are designed to stimulate the patient’s immune system, particularly T-cells, to recognize and attack cancer cells. The vaccine works by training the immune system to identify specific proteins (antigens) found on B-cells, including CD20, CD22, CD37, and BAFF-receptor[1].

Clinical Trial Overview

EO2463 is currently being studied in a global, multicenter Phase 1/2 clinical trial. The trial is investigating the use of EO2463 in several ways[1]:

  1. As a standalone treatment (monotherapy)
  2. In combination with lenalidomide (a medication that modifies the immune system)
  3. In combination with rituximab (an antibody therapy that targets B-cells)
  4. In combination with both lenalidomide and rituximab

The trial is divided into two main phases:

Phase 1: This phase aims to determine the safe and recommended dose of EO2463 for further study. It will also assess the safety of combining EO2463 with other treatments.

Phase 2: This phase will evaluate how well EO2463 works in treating indolent NHL by measuring the objective response rate (ORR). The ORR is the percentage of patients whose cancer shrinks or disappears after treatment[1].

Potential Benefits

While the effectiveness of EO2463 is still being studied, the researchers hope to see several potential benefits, including:

  • Improved response rates for patients with indolent NHL
  • Longer-lasting responses to treatment
  • Delayed need for additional cancer treatments
  • Improved progression-free survival (time without cancer growth)
  • Better overall survival rates

The trial will also look at how EO2463 affects various immune cells and antibodies in the body, which could provide valuable information about how the treatment works[1].

Eligibility Criteria

The trial has specific criteria for who can participate. Some key eligibility factors include:

  • Age 18 or older
  • Diagnosed with follicular lymphoma or marginal zone lymphoma
  • HLA-A2 positive (a specific genetic marker)
  • Measurable disease (tumors that can be assessed)
  • Varying requirements for prior treatments, depending on the study group

There are also several factors that may exclude someone from participating, such as certain medical conditions or previous treatments. It’s important to discuss eligibility with a healthcare provider[1].

Safety Considerations

As with any new treatment, safety is a primary concern. The trial will closely monitor participants for side effects and adverse events. Some specific safety measures include:

  • Regular check-ups and laboratory tests
  • Monitoring of immune system changes
  • Strict guidelines for pregnancy prevention due to potential risks associated with some of the combination treatments
  • Long-term follow-up to assess any delayed effects of treatment

It’s important to note that as an experimental treatment, not all potential risks of EO2463 are known. Patients considering participation in the trial should discuss the potential risks and benefits thoroughly with their healthcare team[1].

Aspect Details
Drug Name EO2463
Drug Type Novel microbial-derived peptide therapeutic vaccine
Target Condition Indolent Non-Hodgkin’s Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Trial Phase Phase 1/2
Administration Subcutaneous injection
Combinations Studied EO2463 alone, with lenalidomide, with rituximab, and with both lenalidomide and rituximab
Primary Objectives Determine safe dose, assess safety in combinations, evaluate objective response rate
Key Eligibility Criteria Adults with FL or MZL, HLA-A2 positive, varying disease status based on cohort
Study Duration 9-12 months active treatment, followed by short-term and long-term follow-up

FAQ

  • What is EO2463 and how does it work? EO2463 is a novel microbial-derived peptide therapeutic vaccine being studied for the treatment of indolent Non-Hodgkin's Lymphoma. It works by stimulating the immune system to target specific proteins found on lymphoma cells.
  • What types of lymphoma are being studied in these trials? The trials are focusing on indolent Non-Hodgkin's Lymphoma, specifically Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL).
  • How is EO2463 administered to patients? EO2463 is administered as an emulsion for injection, given subcutaneously (under the skin).
  • What are the main objectives of these clinical trials? The main objectives are to determine the safe and effective dose of EO2463, assess its safety when used alone or in combination with other drugs, and evaluate its effectiveness in treating lymphoma by measuring the objective response rate.
  • Who is eligible to participate in these trials? Eligibility varies by study cohort but generally includes adults (18 years or older) with confirmed FL or MZL, who are HLA-A2 positive, and meet specific criteria regarding their disease status and prior treatments. Some cohorts include newly diagnosed patients, while others focus on those with relapsed or refractory disease.

Ongoing Clinical Trials on Omp65

  • Study of EO2463, Lenalidomide, and Rituximab for Patients with Indolent Non-Hodgkin’s Lymphoma

    Recruiting

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

Glossary

  • Indolent Non-Hodgkin's Lymphoma: A slow-growing type of blood cancer that affects the lymphatic system, specifically the B-cells. It includes subtypes such as Follicular Lymphoma and Marginal Zone Lymphoma.
  • Follicular Lymphoma (FL): A common type of indolent Non-Hodgkin's Lymphoma that develops from B-cells and typically grows slowly.
  • Marginal Zone Lymphoma (MZL): A type of indolent B-cell lymphoma that can occur in the spleen, lymph nodes, or in mucosa-associated lymphoid tissue (MALT).
  • EO2463: A novel microbial-derived peptide therapeutic vaccine being studied for the treatment of indolent Non-Hodgkin's Lymphoma.
  • Lenalidomide: An immunomodulatory drug used in combination with EO2463 in some trial cohorts.
  • Rituximab: A monoclonal antibody that targets CD20 proteins on B-cells, used in combination with EO2463 in some trial cohorts.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • HLA-A2: A specific type of human leukocyte antigen (HLA) that patients must have to be eligible for the trial.
  • Recommended Phase 2 Dose (RP2D): The dose of EO2463 determined to be safe and effective for further study in Phase 2 of the clinical trial.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.

References

  1. http://clinicaltrials.eu/trial/study-of-eo2463-lenalidomide-and-rituximab-for-patients-with-indolent-non-hodgkins-lymphoma/