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Mva-209-Fsp-B3

A new genetic vaccine called Nous-209, which includes the drug Mva-209-Fsp-B3, is being studied in clinical trials for the treatment of advanced colorectal cancer. This vaccine is designed to target tumors with specific genetic characteristics, known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The trials aim to assess the safety and effectiveness of this vaccine when used in combination with another drug called pembrolizumab.

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 also known by the name Nous-209. This vaccine is designed to target a specific type of colorectal cancer called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

The vaccine consists of four components, each named slightly differently:

  • MVA-209-FSP-B1
  • MVA-209-FSP-B2
  • MVA-209-FSP-B3
  • MVA-209-FSP-B4

These components work together as part of the overall MVA-209-FSP treatment[1].

How Does MVA-209-FSP Work?

MVA-209-FSP is a type of genetic vaccine. Here’s a breakdown of how it works:

  1. Modified Virus: The vaccine uses a modified form of a virus called Modified Vaccinia Ankara (MVA). This virus has been altered so it can’t cause disease but can still stimulate the immune system[1].
  2. Genetic Insert: Each of the four MVA-209-FSP components carries a genetic insert. This insert encodes for 209 Frame Shift Peptides (FSPs)[1].
  3. Frame Shift Proteins: These are abnormal proteins found in MSI-H tumors. By introducing these proteins via the vaccine, the goal is to train the immune system to recognize and attack cells producing these abnormal proteins[1].
  4. Immune Response: The vaccine aims to stimulate the body’s immune system to recognize and attack cancer cells that produce these frame shift proteins.

MVA-209-FSP is administered through intramuscular injection, meaning it’s injected directly into a muscle[1].

Target Condition: Microsatellite Instability-High (MSI-H) Colorectal Cancer

MVA-209-FSP is being studied specifically for patients with:

  • Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer: This is a type of colorectal cancer characterized by a high number of genetic mutations. These cancers often produce abnormal proteins (like the frame shift proteins targeted by MVA-209-FSP)[1].
  • Advanced stage: The vaccine is being tested in patients with locally advanced unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body) colorectal cancer[1].

Clinical Trial Details

MVA-209-FSP is currently being studied in a clinical trial. Here are some key details about the trial:

  • Trial Phase: This is a Phase I/II trial, which means it’s testing both the safety and the effectiveness of the treatment[1].
  • Combination Therapy: The vaccine is being studied in combination with another drug called pembrolizumab, which is an immunotherapy drug already used in cancer treatment[1].
  • Main Goal: The primary objective is to assess how well the treatment works by measuring the overall response rate (ORR) of patients’ tumors[1].
  • Secondary Goals: The trial is also looking at safety, how long the treatment effects last, and how long patients live without their cancer getting worse[1].

Eligibility Criteria

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

  • Being 18 years of age or older
  • Having confirmed MSI-H or dMMR colorectal cancer
  • Having cancer that is locally advanced and can’t be surgically removed, or has spread to other parts of the body
  • Having measurable disease according to specific criteria (RECIST v1.1)
  • Having adequate organ function
  • Not being pregnant or breastfeeding

There are also several factors that would exclude a patient from participating, such as certain other medical conditions or previous treatments[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider:

Potential Benefits:

  • The treatment may help slow or stop the growth of cancer cells
  • It may stimulate the immune system to fight cancer more effectively
  • Patients may have access to a new treatment before it’s widely available

Potential Risks:

  • The treatment may not work as well as hoped
  • There may be unexpected side effects
  • Participating in the trial may require more time and medical visits than standard treatment

It’s important to note that as this is an experimental treatment, not all potential risks are known. The clinical trial is designed to gather more information about both the effectiveness and the safety of MVA-209-FSP[1].

Aspect Details
Study Type Phase I/II, Multi-center, Open-Label Study
Drug Nous-209 Genetic Vaccine (including Mva-209-Fsp-B3) + Pembrolizumab
Target Condition Locally advanced unresectable or metastatic MSI-H/dMMR colorectal cancer
Primary Objective Assess anti-tumor activity based on Overall Response Rate (ORR)
Secondary Objectives Evaluate safety, tolerability, Best Overall Response, Duration of Response, Progression-Free Survival
Key Eligibility Criteria Age ≥18, MSI-H/dMMR status, adequate organ function, ECOG status 0/1
Administration Route Intramuscular injection

FAQ

  • What is Mva-209-Fsp-B3? Mva-209-Fsp-B3 is one of four components of a genetic vaccine called Nous-209. It is designed to target specific proteins found in certain types of colorectal cancer.
  • What type of cancer is being studied in these trials? The trials are focusing on locally advanced unresectable or metastatic colorectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
  • 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 these clinical trials? The main goal is to assess the anti-tumor activity of the vaccination regimen plus pembrolizumab, primarily by measuring the overall response rate (ORR) of patients to the treatment.
  • Who is eligible to participate in these 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 of the trial.

Ongoing Clinical Trials on Mva-209-Fsp-B3

  • 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 certain areas of DNA called microsatellites. This is often associated with defects in the ability to repair DNA mistakes.
  • Mismatch Repair Deficient (dMMR): A condition where cells lack the ability to correct mistakes made when DNA is copied during cell division. This can lead to the accumulation of genetic mutations.
  • Genetic Vaccine: A type of vaccine that uses genetic material (DNA or RNA) to stimulate an immune response against specific proteins, in this case, those associated with cancer cells.
  • Pembrolizumab: An immunotherapy drug that helps the immune system recognize and attack cancer cells more effectively.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a 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 getting worse.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.

References

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