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Mva-209-Fsp-B1

This article discusses the ongoing clinical trials of Mva-209-Fsp-B1, a component of the Nous-209 genetic vaccine. This innovative treatment is being studied for patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The trials aim to assess the vaccine’s effectiveness when combined with pembrolizumab, an immunotherapy drug, in treating this specific type of colorectal cancer.

Table of Contents

What is MVA-209-FSP?

MVA-209-FSP is an experimental genetic vaccine being studied for the treatment of advanced colorectal cancer[1]. It is specifically designed for patients whose cancer has a characteristic called “microsatellite instability-high” (MSI-H) or “mismatch repair deficient” (dMMR)[1]. These terms describe genetic features of the cancer that make it potentially responsive to this type of treatment.

The vaccine is made up of four components, known as MVA-209-FSP-B1, MVA-209-FSP-B2, MVA-209-FSP-B3, and MVA-209-FSP-B4[1]. Each of these components is based on a modified version of a virus called Modified Vaccinia Ankara (MVA), which has been engineered to be safe for use in humans.

How does MVA-209-FSP work?

MVA-209-FSP works by introducing genetic material into the body that encodes for 209 specific proteins called Frame Shift Peptides (FSPs)[1]. These FSPs are abnormal proteins that are often found in MSI-H/dMMR cancers but not in normal cells. By presenting these proteins to the immune system, the vaccine aims to “train” the body’s defenses to recognize and attack cancer cells that produce these abnormal proteins.

The vaccine is given by intramuscular injection, meaning it’s injected directly into a muscle[1]. This method of administration helps to stimulate a strong immune response.

Who is this treatment for?

MVA-209-FSP is being studied in patients with:

  • Advanced colorectal cancer: This includes cancer that is locally advanced (has spread to nearby tissues) and cannot be surgically removed, or metastatic (has spread to other parts of the body)[1].
  • MSI-H or dMMR status: These are specific genetic characteristics of the tumor that must be confirmed through testing[1].
  • Age 18 or older[1].

Clinical Trial Details

The clinical trial for MVA-209-FSP is a Phase I/II study, which means it’s in the early stages of testing in humans[1]. The study is designed to:

  1. Evaluate the safety and tolerability of the vaccine when given in combination with another drug called pembrolizumab (an immunotherapy drug)[1].
  2. Assess how well the treatment works in shrinking or controlling the growth of tumors[1].

The trial includes different groups of patients:

  • Some who have not previously received immunotherapy treatment[1].
  • Some who have previously received immunotherapy but whose cancer has progressed[1].

Potential Benefits

While it’s important to remember that MVA-209-FSP is still experimental, the researchers hope to see the following benefits:

  • Shrinkage of tumors or slowing of tumor growth[1].
  • Longer periods without the cancer getting worse (progression-free survival)[1].
  • Potentially improved outcomes for patients who have not responded to or have progressed after other treatments[1].

Safety Considerations

As with any experimental treatment, there are potential risks and side effects. The clinical trial is designed to carefully monitor patients for any adverse reactions. Some important safety considerations include:

  • Patients must have adequate organ function and blood test results to participate in the trial[1].
  • Certain medical conditions or prior treatments may exclude someone from participating in the trial[1].
  • Patients who are pregnant, breastfeeding, or planning to become pregnant cannot participate[1].
  • The trial excludes people with certain active infections or immune system disorders[1].

It’s crucial for patients to discuss all potential risks and benefits with their healthcare team before considering participation in this or any clinical trial.

Aspect Details
Drug Name Mva-209-Fsp-B1 (part of Nous-209 genetic vaccine)
Trial Phase Phase I/II
Target Condition Advanced MSI-H or dMMR Colorectal Cancer
Administration Intramuscular injection
Combination Therapy With pembrolizumab (immunotherapy)
Primary Endpoint Overall Response Rate (ORR)
Secondary Endpoints Safety, tolerability, Best Overall Response, Duration of Response, Progression-Free Survival
Key Eligibility Criteria Adults with confirmed MSI-H/dMMR colorectal cancer, adequate organ function, life expectancy ≥6 months

FAQ

  • What is Mva-209-Fsp-B1? Mva-209-Fsp-B1 is one of four components of the Nous-209 genetic vaccine. It is a Modified Vaccinia Ankara (MVA) vector that carries genetic information encoding Frame Shift Proteins (FSPs), which are designed to target specific cancer cells.
  • What type of cancer is this treatment being tested for? The treatment is being tested for locally advanced unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
  • How is the vaccine administered? The vaccine is administered through intramuscular injection, which means it is injected directly into the muscle.
  • What is the main goal of the clinical trials? The main goal is to assess the anti-tumor activity of the vaccination regimen combined with pembrolizumab, measured by the Overall Response Rate (ORR) according to RECIST v1.1 criteria.
  • Who is eligible for these clinical trials? Eligible participants include adults (18 years or older) with confirmed MSI-H or dMMR colorectal cancer, adequate organ function, and a life expectancy of at least 6 months. Specific eligibility criteria vary between different phases and cohorts of the study.

Ongoing Clinical Trials on Mva-209-Fsp-B1

  • 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

  • Microsatellite Instability-High (MSI-H): A condition where cells have a high number of genetic changes in microsatellites, which are short, repeated sequences of DNA. This is often associated with certain types of cancer, including some colorectal cancers.
  • Mismatch Repair Deficient (dMMR): A condition where cells lack the ability to correct mistakes in DNA replication, leading to an accumulation of genetic errors. This can contribute to the development of certain cancers.
  • Modified Vaccinia Ankara (MVA): A weakened form of the vaccinia virus used as a vector in vaccine development. It can carry genetic information to stimulate an immune response against specific targets, such as cancer cells.
  • Frame Shift Proteins (FSPs): Proteins produced as a result of genetic mutations that alter the reading frame of DNA. In this context, they are used as targets for the immune system to recognize and attack cancer cells.
  • RECIST v1.1: Response Evaluation Criteria in Solid Tumors version 1.1, a standardized method to measure how well a cancer patient responds to treatment by assessing changes in tumor size.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. It is a measure of treatment effectiveness in cancer clinical trials.
  • Pembrolizumab: An immunotherapy drug that helps the immune system detect and fight cancer cells. It is being used in combination with the Nous-209 vaccine in these clinical trials.

References

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