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Fusion Protein Of Il-2 And Humanised Igg1 Monoclonal Antibody Against Il-2

This article discusses a Phase II clinical trial investigating the use of ANV419, a fusion protein of IL-2 and humanized IgG1 monoclonal antibody against IL-2, in adoptive cell therapy for patients with advanced solid tumors. The study aims to compare ANV419 with high-dose IL-2 in terms of safety, efficacy, and patient-reported outcomes in the treatment of melanoma, non-small cell lung cancer, and cervical cancer.

Table of Contents

What is ANV419?

ANV419 is an innovative drug being studied for cancer treatment[1]. It is classified as a fusion protein, which means it combines two different proteins into one. Specifically, ANV419 is made up of: 1. Interleukin-2 (IL-2): A protein that helps stimulate the immune system 2. A humanized IgG1 monoclonal antibody against IL-2: An antibody designed to interact with IL-2 This unique combination is designed to enhance the body’s natural ability to fight cancer.

How Does ANV419 Work?

ANV419 works by boosting the immune system’s ability to recognize and attack cancer cells[1]. The IL-2 component stimulates the growth and activity of certain immune cells, particularly T cells, which are crucial in fighting cancer. The antibody part of ANV419 is designed to modify how IL-2 interacts with the body, potentially improving its effectiveness and reducing side effects compared to using IL-2 alone.

Target Conditions

The clinical trial is focusing on patients with advanced solid tumors, specifically[1]:

  • Melanoma: A type of skin cancer
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer
  • Cervical cancer: Cancer that begins in the cervix
These cancers have been chosen because they are known to respond to immunotherapy treatments.

Clinical Trial Overview

ANV419 is currently being studied in a Phase II clinical trial[1]. This trial, called PragmaTIL, is comparing ANV419 to high-dose IL-2 in combination with a treatment called Tumor Infiltrating Lymphocytes (TIL) therapy. The main goals of the trial are:

  1. To see if ANV419 causes fewer severe side effects than high-dose IL-2
  2. To evaluate how well patients tolerate the treatment
  3. To measure how effective ANV419 is in treating cancer
  4. To assess patients’ quality of life during treatment
Patients in the trial will receive either ANV419 or high-dose IL-2 after undergoing TIL therapy, which involves using a patient’s own immune cells to fight their cancer.

Potential Benefits

Researchers hope that ANV419 will offer several advantages over current treatments[1]:

  • Fewer and less severe side effects compared to high-dose IL-2
  • Improved quality of life for patients during treatment
  • Potentially better cancer-fighting ability
  • Easier administration for patients and healthcare providers
However, it’s important to note that these potential benefits are still being studied and are not yet proven.

Safety and Side Effects

As with any new treatment, safety is a top priority in the ANV419 clinical trial[1]. The researchers are closely monitoring for side effects, particularly those that might be related to stimulating the immune system. Some potential side effects being watched for include:

  • Skin rash
  • Fatigue
  • Muscle pain
  • Fever and chills
  • Changes in blood pressure
  • Breathing difficulties
  • Changes in liver or kidney function
The trial is designed to compare the side effects of ANV419 with those of high-dose IL-2, which is known to have significant side effects in some patients.

Patient Experience

The clinical trial is not only focused on the medical aspects of treatment but also on understanding the patient experience[1]. Researchers are collecting information on:

  • Quality of life during treatment
  • Anxiety and depression levels
  • Physical parameters like heart rate, mobility, and sleep patterns
  • Patients’ personal experiences and expectations through interviews
This comprehensive approach aims to provide a fuller picture of how ANV419 affects patients’ lives beyond just its medical effects.

Future Prospects

If ANV419 proves to be safe and effective in this clinical trial, it could potentially become a new option for treating certain types of advanced cancer[1]. The researchers are also conducting economic analyses to understand the potential costs and benefits of ANV419 compared to current treatments. This information will be crucial in determining whether ANV419 could be widely adopted in healthcare systems.

It’s important to remember that ANV419 is still in the research phase. While the results so far are promising enough to warrant this Phase II trial, more studies will be needed before it can be considered for approval as a standard treatment.

Aspect Details
Study Type Phase II randomized clinical trial
Intervention ANV419 (IL-2 analog) vs. High-dose IL-2 in Adoptive Cell Therapy
Target Conditions Advanced melanoma, non-small cell lung cancer (NSCLC), cervical cancer
Primary Objectives Assess safety and patient-reported outcomes of ANV419 vs. high-dose IL-2
Secondary Objectives Evaluate efficacy, quality of life, anxiety/depression, and health technology assessment
Key Eligibility Criteria Adults with advanced solid tumors, adequate organ function, measurable disease
Primary Endpoints Number of grade ≥3 adverse events, change in PRO-CTCAE composite score
Secondary Endpoints Overall response rate, duration of response, progression-free survival, overall survival

FAQ

  • What is ANV419 and how does it differ from high-dose IL-2? ANV419 is a fusion protein of IL-2 and a humanized IgG1 monoclonal antibody against IL-2. It is an IL-2 analog designed to potentially improve upon the effects of high-dose IL-2 in adoptive cell therapy. The main difference is that ANV419 is engineered to potentially reduce side effects while maintaining or improving efficacy compared to traditional high-dose IL-2.
  • What types of cancer are being studied in this clinical trial? This clinical trial is focusing on advanced solid tumors, specifically melanoma, non-small cell lung cancer (NSCLC), and cervical cancer.
  • What is the main objective of this clinical trial? The main objective is to determine if using ANV419 in tumor-infiltrating lymphocyte (TIL) adoptive cell therapy reduces the number of severe side effects compared to high-dose IL-2, and if it improves patient-reported outcomes.
  • Who is eligible to participate in this clinical trial? Eligible participants include adults (18 years or older) with advanced melanoma, NSCLC, or cervical cancer that has progressed after at least one standard therapy. They must have adequate organ function, measurable disease, and be medically fit to undergo all study procedures.
  • How will the effectiveness of ANV419 be measured in this trial? The effectiveness will be measured through various endpoints, including the frequency and severity of side effects, overall response rate, duration of response, progression-free survival, and overall survival. Additionally, quality of life measures and patient-reported outcomes will be assessed.

Ongoing Clinical Trials on Fusion Protein Of Il-2 And Humanised Igg1 Monoclonal Antibody Against Il-2

  • Study Comparing ANV419 and High Dose IL2 in Adoptive Cell Therapy for Patients with Melanoma, Non-Small Cell Lung Cancer, and Cervical Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark The Netherlands Spain

Glossary

  • Adoptive Cell Therapy (ACT): A type of immunotherapy where a patient's own immune cells are collected, modified or expanded in the laboratory, and then reinfused to fight cancer.
  • Tumor Infiltrating Lymphocytes (TIL): Immune cells found in and around tumors, which can be extracted, expanded, and reinfused as part of adoptive cell therapy.
  • IL-2 (Interleukin-2): A protein that regulates the activities of white blood cells that are responsible for immunity. It is used in some forms of immunotherapy.
  • ANV419: An experimental drug that is a fusion protein of IL-2 and a humanized IgG1 monoclonal antibody against IL-2, designed to potentially improve upon the effects of high-dose IL-2 in cancer treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Common Terminology Criteria for Adverse Events (CTCAE): A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.

References

  1. http://clinicaltrials.eu/trial/study-comparing-anv419-and-high-dose-il2-in-adoptive-cell-therapy-for-patients-with-melanoma-non-small-cell-lung-cancer-and-cervical-cancer/