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Pervi-Neo

A groundbreaking clinical trial is underway to evaluate the effectiveness of a personalized peptide vaccine, including Pervi-Neo, for children and young adults with metastatic fusion-driven sarcomas. This phase I/II trial aims to assess the vaccine’s ability to induce T-cell responses in patients who have undergone standard treatment for Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma. The study focuses on patients in first or second complete remission or partial response, offering hope for improved outcomes in these aggressive cancers.

Table of Contents

What is PERVI-NEO?

PERVI-NEO is part of an innovative personalized peptide vaccine called IPX vaccine, which is currently being studied for the treatment of certain types of metastatic sarcomas in children and young adults[1]. This vaccine is designed to be tailored to each patient’s specific cancer characteristics, making it a form of personalized medicine.

The IPX vaccine contains three main components:

  • PERVI-FUS: A peptide targeting fusion proteins specific to certain sarcomas
  • PERVI-NEO: A peptide targeting patient-specific cancer mutations
  • 11902A: Another component of the vaccine formulation

These components are combined in an emulsion for injection, which means they are mixed into a liquid form that can be injected into the patient[1].

Target Conditions

The PERVI-NEO vaccine is being studied for use in patients with specific types of metastatic sarcomas, which are cancers that develop in soft tissues or bones and have spread to other parts of the body. The targeted sarcomas are known as “fusion-driven” sarcomas, including[1]:

  • Ewing sarcoma: A rare cancer that typically affects bones or soft tissues around bones
  • Alveolar rhabdomyosarcoma: A type of soft tissue cancer that develops in muscle tissue
  • Synovial sarcoma: A rare cancer that can occur in various locations in the body, often near joints

The term “fusion-driven” refers to these cancers being caused by specific genetic alterations where parts of two different genes fuse together, creating an abnormal protein that drives cancer growth.

How PERVI-NEO Works

PERVI-NEO is designed to stimulate the patient’s immune system to recognize and attack cancer cells. Here’s how it works[1]:

  1. Scientists analyze the patient’s cancer cells to identify specific genetic mutations and fusion proteins.
  2. Based on this analysis, they create personalized peptides (small protein fragments) that match the patient’s cancer characteristics.
  3. These peptides are then used to create the vaccine, which includes PERVI-FUS (targeting fusion proteins) and PERVI-NEO (targeting patient-specific mutations).
  4. When injected, the vaccine is designed to “train” the patient’s immune system, particularly T cells (a type of white blood cell), to recognize and attack cancer cells displaying these specific peptides.

Clinical Trial Details

PERVI-NEO is currently being studied in a Phase I/II clinical trial. Here are some key details about the study[1]:

  • Trial objective: To assess the ability of the individualized fusion-peptide and neopeptide vaccination to induce a T-cell response in patients
  • Secondary objectives: To evaluate the feasibility, safety, and tolerability of the vaccine, as well as gather early efficacy data
  • Patient group: Children and young adults (ages 2-40) with metastatic fusion-driven sarcomas who have completed standard treatment and are in complete remission or partial response
  • Dosage: The maximum daily dose is 0.3 mg, with a maximum total dose of 0.9 mg over the treatment period
  • Treatment duration: Up to 113 days

Eligibility Criteria

To participate in the clinical trial, patients must meet specific criteria. Some key inclusion criteria include[1]:

  • Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing sarcoma, or synovial sarcoma
  • Complete remission or partial response after standard therapy
  • Availability of genetic sequencing data for the patient’s cancer
  • Successful design and production of the patient-specific vaccine

There are also several exclusion criteria, such as certain medical conditions, ongoing infections, or use of medications that might interfere with the vaccine’s effectiveness.

Potential Benefits and Risks

As PERVI-NEO is still in clinical trials, its full benefits and risks are not yet known. However, potential benefits and considerations include[1]:

  • Potential benefits:
    • Personalized treatment approach
    • Potential to stimulate the immune system against cancer cells
    • May help prevent cancer recurrence in high-risk patients
  • Considerations and potential risks:
  • As with any medical treatment, there may be side effects or risks
  • The effectiveness of the treatment is still being studied
  • The treatment requires genetic analysis and personalized vaccine production, which may take time

It’s important to note that PERVI-NEO is still an experimental treatment. Patients and families considering participation in the clinical trial should discuss the potential benefits and risks thoroughly with their healthcare team.

Aspect Details
Trial Type Phase I/II
Target Population Children and young adults (2-40 years) with metastatic fusion-driven sarcomas
Conditions Ewing sarcoma, alveolar rhabdomyosarcoma, synovial sarcoma
Treatment Personalized peptide vaccine (IPX vaccine) including Pervi-Neo
Primary Objective Assess vaccine-induced T-cell response
Secondary Objectives Evaluate feasibility, safety, and early efficacy data
Primary Endpoint T-cell response without unacceptable toxicity
Key Secondary Endpoints T-cell responses, Event-free survival, Overall survival, Quality of life
Dosage Max daily dose: 0.3 mg, Max total dose: 0.9 mg
Treatment Duration Up to 113 days

FAQ

  • What is Pervi-Neo and how is it used in this clinical trial? Pervi-Neo is one of the components of the personalized peptide vaccine called IPX vaccine. It is used alongside other components (Pervi-Fus and 11902A) to create an individualized treatment for patients with metastatic fusion-driven sarcomas. The vaccine is designed to stimulate the patient's immune system to fight against their specific cancer cells.
  • Who is eligible for this clinical trial? The trial is open to patients aged 2-40 years with metastatic fusion-driven sarcomas (Ewing sarcoma, alveolar rhabdomyosarcoma, or synovial sarcoma) who are in first or second complete remission or partial response after standard treatment. Patients must have undergone whole exome sequencing and RNAseq data of the gene fusion must be available.
  • What are the main objectives of this clinical trial? The main objective is to assess the T-cell response induced by the individualized fusion-peptide and neopeptide vaccination. Secondary objectives include evaluating the feasibility and safety of the vaccination, as well as gathering early efficacy data on event-free and overall survival.
  • How is the vaccine administered? The IPX vaccine, which includes Pervi-Neo, is administered as an emulsion for injection. The maximum daily dose is 0.3 mg, with a maximum total dose of 0.9 mg over a treatment period of up to 113 days.
  • What are the primary endpoints of the trial? The primary endpoint is 'success of treatment,' defined as the patient showing a vaccination-induced T-cell response to either of the two patient-specific peptides without unacceptable toxicity until the Follow-up visit, which occurs 28 ± 7 days after the last vaccination.

Ongoing Clinical Trials on Pervi-Neo

  • Study of Personalized Peptide Vaccine with PERVI-FUS, PERVI-NEO, and 11902A for Children and Young Adults with Metastatic Fusion-Driven Sarcomas

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Fusion-driven sarcomas: A type of cancer that develops in soft tissues or bones, characterized by specific genetic alterations where two genes fuse together, leading to abnormal cell growth.
  • Ewing sarcoma: A rare type of cancer that occurs in bones or in the soft tissue around the bones, primarily affecting children and young adults.
  • Alveolar rhabdomyosarcoma: An aggressive type of soft tissue cancer that develops from skeletal muscle cells and primarily affects children and adolescents.
  • Synovial sarcoma: A rare type of cancer that typically occurs near the joints of the arm, neck, or leg, affecting mainly young adults.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Complete remission (CR): A state where all signs and symptoms of cancer have disappeared, although cancer may still be present in the body.
  • Partial response (PR): A decrease in the size or extent of cancer in response to treatment, but not a complete disappearance.
  • T-cell response: The activation of specific immune cells (T-cells) to recognize and attack cancer cells.
  • Whole exome sequencing: A genetic test that examines all the protein-coding regions of genes in a person's genome.
  • RNAseq: A technique used to analyze the presence and quantity of RNA in a biological sample, helping to understand gene expression.
  • Personalized peptide vaccine: A cancer treatment approach that uses specific proteins (peptides) tailored to an individual patient's cancer to stimulate their immune system.
  • Event-free survival (EFS): The length of time after treatment during which no specified adverse event (such as cancer recurrence) is detected.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. http://clinicaltrials.eu/trial/study-of-personalized-peptide-vaccine-with-pervi-fus-pervi-neo-and-11902a-for-children-and-young-adults-with-metastatic-fusion-driven-sarcomas/