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This article discusses the clinical trials of EO2463, an innovative cancer vaccine therapy being studied for the treatment of indolent Non-Hodgkin’s Lymphoma (NHL). The trials aim to evaluate the safety, efficacy, and optimal dosing of EO2463 when used alone or in combination with other treatments like lenalidomide and rituximab. The study focuses on patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL), two subtypes of indolent NHL.

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), specifically Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL).[1]

This innovative therapy is composed of several peptides (small protein fragments) named OMP72, OMP64, OMP65, OMP66, and UCP2. These peptides are derived from microbes and have been designed to stimulate the immune system to fight against lymphoma cells.[1]

Target Conditions

EO2463 is being developed to treat two specific types of indolent (slow-growing) Non-Hodgkin’s Lymphoma:

  • Follicular Lymphoma (FL): A type of lymphoma that develops from B-lymphocytes (a type of white blood cell) in the lymph nodes.
  • Marginal Zone Lymphoma (MZL): 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 designed to work as a therapeutic vaccine, meaning it aims to stimulate the patient’s own immune system to fight against cancer cells. The peptides in EO2463 are thought to activate T cells (a type of immune cell) that can recognize and attack lymphoma cells.[1]

Specifically, the vaccine is designed to target certain proteins found on B cells (the cells that become cancerous in FL and MZL), including CD20, CD22, CD37, and BAFF-receptor. By training the immune system to recognize these proteins, EO2463 may help the body identify and destroy lymphoma cells more effectively.[1]

Clinical Trial Overview

EO2463 is currently being studied in a Phase 1/2 clinical trial. This trial aims to:

  1. Determine the safe and effective dose of EO2463 (Phase 1)
  2. Evaluate how well EO2463 works in treating indolent NHL (Phase 2)
  3. Assess the safety and effectiveness of EO2463 when used alone or in combination with other drugs (lenalidomide and rituximab)[1]

The trial includes several different groups (cohorts) of patients, including both newly diagnosed and previously treated individuals with FL or MZL.[1]

Eligibility Criteria

To participate in the EO2463 clinical trial, patients must meet certain criteria. Some key eligibility factors include:

  • Age 18 or older
  • Diagnosed with FL or MZL
  • HLA-A2 positive (a specific genetic marker)
  • Measurable disease (at least one lymph node or tumor mass ≥ 1.5 cm)
  • For some cohorts, patients must have received prior treatment
  • For other cohorts, patients must be newly diagnosed and untreated[1]

There are also several exclusion criteria, such as certain medical conditions or prior treatments that would make a patient ineligible for the trial. It’s important to discuss all eligibility criteria with a healthcare provider or clinical trial coordinator.

Potential Benefits and Risks

As with any experimental treatment, EO2463 may offer potential benefits but also carries risks:

Potential benefits:

  • A new treatment option for patients with indolent NHL
  • Possibility of stimulating the immune system to fight cancer
  • Potential for fewer side effects compared to traditional chemotherapy

Potential risks:

  • Unknown or unexpected side effects
  • The treatment may not be effective for everyone
  • Possible immune-related side effects[1]

Administration and Treatment Schedule

EO2463 is administered as a subcutaneous injection (an injection under the skin). The exact treatment schedule varies depending on which cohort a patient is in, but generally includes:

  • An initial period of EO2463 alone (monotherapy)
  • Possible addition of other drugs (lenalidomide and/or rituximab) later in the treatment course
  • Regular monitoring and follow-up visits[1]

The active treatment period lasts between 9 to 12 months, followed by a period of follow-up to monitor long-term effects and outcomes.[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
Combination Therapies Lenalidomide and/or Rituximab (in some cohorts)
Primary Objectives Determine recommended Phase 2 dose, assess safety, estimate objective response rate
Key Eligibility Criteria Adults with FL or MZL, HLA-A2 positive, measurable disease
Trial 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 designed to treat indolent Non-Hodgkin's Lymphoma. It works by stimulating the immune system to recognize and attack cancer cells, specifically targeting B-cell antigens associated with lymphoma.
  • Who is eligible for the EO2463 clinical trials? Eligibility varies by cohort but generally includes adults (18 years or older) with biopsy-proven Follicular Lymphoma or Marginal Zone Lymphoma. Patients must be HLA-A2 positive and have measurable disease. Some cohorts include newly diagnosed patients, while others focus on those with relapsed or refractory disease.
  • What are the main objectives of the EO2463 clinical trials? The main objectives are to determine the recommended phase 2 dose (RP2D) for EO2463 monotherapy, assess its safety when combined with other treatments, and estimate the objective response rate (ORR) in patients receiving EO2463.
  • How is EO2463 administered in the clinical trials? EO2463 is administered as an emulsion for injection, given subcutaneously (under the skin). The duration of treatment and combination with other drugs varies depending on the specific cohort and trial phase.
  • What are the potential side effects or risks of participating in the EO2463 trials? While specific side effects are not detailed in the provided information, the trials closely monitor for adverse events, treatment-emergent adverse events, and laboratory abnormalities. Patients with certain pre-existing conditions, active infections, or history of autoimmune disorders may be excluded to minimize risks.

Ongoing Clinical Trials on Omp72

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

    Recruiting

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

Glossary

  • Indolent Non-Hodgkin's Lymphoma (NHL): A slow-growing type of blood cancer that affects the lymphatic system, particularly B-cells. It includes subtypes like Follicular Lymphoma and Marginal Zone Lymphoma.
  • Follicular Lymphoma (FL): A common subtype of indolent NHL that develops from B-lymphocytes and typically grows slowly.
  • Marginal Zone Lymphoma (MZL): A subtype of indolent NHL that affects B-cells in the marginal zone of lymphoid tissues.
  • EO2463: A novel microbial-derived peptide therapeutic vaccine being studied for the treatment of indolent NHL.
  • 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.
  • Recommended Phase 2 Dose (RP2D): The optimal dose of a drug determined in early-phase clinical trials for use in later-phase studies.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • HLA-A2: A specific human leukocyte antigen type that patients must have to be eligible for the EO2463 trials.
  • ECOG Performance Status: A scale used to assess a patient's level of functioning and ability to care for themselves.

References

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