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Mva-209-Fsp-B2

A groundbreaking clinical trial is underway to evaluate the effectiveness of Mva-209-Fsp-B2, a component of the Nous-209 genetic vaccine, in treating advanced colorectal cancer. This innovative approach combines the vaccine with pembrolizumab, an immunotherapy drug, to target microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors. The study aims to assess the safety, tolerability, and potential anti-tumor activity of this combination therapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Table of Contents

What is MVA-209-FSP?

MVA-209-FSP is an investigational genetic vaccine being developed for the treatment of certain types of cancer[1]. It is also known by the name “Nous-209” and is classified as a solution for injection[1]. This innovative treatment is currently being studied in clinical trials to evaluate its effectiveness and safety.

How does MVA-209-FSP work?

MVA-209-FSP is a complex vaccine composed of four different vectors (MVA-209-FSP-B1, MVA-209-FSP-B2, MVA-209-FSP-B3, and MVA-FSP-B4)[1]. These vectors are based on a modified form of the vaccinia virus called Modified Vaccinia Ankara (MVA). Each vector carries genetic information that encodes for 209 Frame Shift Peptides (FSPs)[1].

Frame Shift Peptides are unique proteins that can be produced in certain types of cancer cells due to genetic errors. By introducing these FSPs into the body, the vaccine aims to stimulate the immune system to recognize and attack cancer cells that produce these abnormal proteins[1].

What conditions does MVA-209-FSP target?

MVA-209-FSP is being developed to treat microsatellite unstable solid tumors. Specifically, the current clinical trial is focusing on patients with:

  • Locally advanced unresectable or metastatic colorectal cancer (CRC) that is:
    • Microsatellite instability-high (MSI-H), or
    • Mismatch repair deficient (dMMR)[1]

These terms may sound complex, so let’s break them down:

  • Locally advanced unresectable: The cancer has spread from where it started to nearby tissue or lymph nodes and cannot be completely removed with surgery.
  • Metastatic: The cancer has spread to other parts of the body.
  • Microsatellite instability-high (MSI-H): This refers to a characteristic of the tumor where there are many errors in certain areas of the DNA called microsatellites.
  • Mismatch repair deficient (dMMR): This means the tumor has problems with a normal process that fixes mistakes in DNA when cells divide[1].

Current Clinical Trial

MVA-209-FSP is currently being studied in a Phase I/II clinical trial. This trial is designed to evaluate both the safety and effectiveness of the vaccine when combined with another drug called pembrolizumab[1]. The main goals of the trial include:

  1. Assessing the safety and tolerability of the treatment combination
  2. Measuring how well the tumors respond to the treatment (called the Overall Response Rate or ORR)
  3. Determining how long the treatment effects last (Duration of Response or DoR)
  4. Evaluating how long patients live without their cancer getting worse (Progression-Free Survival or PFS)[1]

Who is eligible for the trial?

The trial is open to adults (18 years or older) with specific types of colorectal cancer. Some key eligibility criteria include:

  • Having locally advanced unresectable or metastatic colorectal cancer that is MSI-H or dMMR
  • Having a life expectancy of at least 6 months
  • Being in relatively good overall health (ECOG Performance Status of 0 or 1)
  • Having measurable disease according to specific criteria (RECIST version 1.1)
  • Not having received certain previous treatments (depending on which part of the trial they’re entering)[1]

Safety Considerations

As with any clinical trial, there are important safety considerations. Some patients may not be eligible if they have:

  • Certain active infections or a weakened immune system
  • Active brain metastases
  • A history of certain lung conditions
  • Recently received live virus vaccines
  • Certain other medical conditions that might interfere with the study[1]

It’s important to note that this is an investigational treatment, and its full safety profile is still being studied. Patients considering participating in the trial should discuss all potential risks and benefits with their healthcare provider.

Aspect Details
Study Type Phase I/II, Multicenter, Open-Label
Main Intervention Nous-209 Genetic Vaccine (including Mva-209-Fsp-B2) + Pembrolizumab
Target Condition Advanced MSI-H/dMMR Colorectal Cancer
Primary Endpoint Overall Response Rate (ORR) by RECIST v1.1
Secondary Endpoints Safety, Tolerability, Best Overall Response, Duration of Response, Progression-Free Survival
Key Eligibility Criteria Age ≥18, ECOG 0-1, Adequate Organ Function, Measurable Disease
Exclusion Criteria Immunodeficiency, Active Severe Infections, Untreated HBV/HCV, Active CNS Metastases
Administration Route Intramuscular Injection (for Mva-209-Fsp-B2)

FAQ

  • What is Mva-209-Fsp-B2? Mva-209-Fsp-B2 is one of four components of the Nous-209 genetic vaccine. It is a Modified Vaccinia Ankara (MVA) vector that carries genetic material encoding Frame Shift Proteins (FSPs). This vaccine is designed to target specific tumor markers in colorectal cancer patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.
  • How is Mva-209-Fsp-B2 administered in the clinical trial? Mva-209-Fsp-B2 is administered as part of the Nous-209 genetic vaccine through intramuscular injection. The vaccine is given in combination with pembrolizumab, an immunotherapy drug, to potentially enhance the immune response against cancer cells.
  • Who is eligible for this clinical trial? The trial is primarily for patients aged 18 and older with locally advanced unresectable or metastatic colorectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Patients must have adequate organ function and meet specific criteria regarding prior treatments and overall health status.
  • What are the main objectives of the clinical trial? The main objectives of the trial are to assess the safety and tolerability of the Nous-209 genetic vaccine (including Mva-209-Fsp-B2) in combination with pembrolizumab, and to evaluate its potential anti-tumor activity. This includes measuring the overall response rate, duration of response, and progression-free survival in patients.
  • Are there any specific exclusion criteria for the trial? Yes, there are several exclusion criteria. These include having certain immunodeficiencies, active severe infections, untreated hepatitis B or C, active central nervous system metastases, and a history of non-infectious pneumonitis. Patients who have received live-virus vaccinations within 30 days of starting the trial treatment are also excluded.

Ongoing Clinical Trials on Mva-209-Fsp-B2

  • Study of Nous-209 Genetic Vaccine and Pembrolizumab for Patients with Advanced Microsatellite Instability-High Colorectal Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain

Glossary

  • Mva-209-Fsp-B2: A component of the Nous-209 genetic vaccine, which is a Modified Vaccinia Ankara (MVA) vector carrying genetic material encoding Frame Shift Proteins (FSPs) designed to target specific tumor markers in colorectal cancer.
  • Microsatellite Instability-High (MSI-H): A condition where the number of repeated DNA sequences (microsatellites) in tumor cells is different from normal cells, indicating a defect in the DNA mismatch repair system.
  • Mismatch Repair Deficient (dMMR): A condition where cells have mutations in genes responsible for repairing mistakes in DNA replication, leading to an accumulation of errors in the DNA.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells by blocking a protein called PD-1 on immune cells.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standard set of rules used to measure how well a cancer patient responds to treatment.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: A scale used to assess how a patient's disease affects their daily living abilities and determine appropriate treatment and prognosis.
  • Frame Shift Proteins (FSPs): Abnormal proteins produced by cancer cells due to genetic mutations, which can be targeted by the immune system when stimulated by the vaccine.

References

  1. http://clinicaltrials.eu/trial/study-of-nous-209-genetic-vaccine-and-pembrolizumab-for-patients-with-advanced-microsatellite-instability-high-colorectal-cancer/