live attenuated listeria encoding human mesothelin vaccine crs 207

Drug Overview

Live attenuated listeria encoding human mesothelin vaccine CRS 207 is a highly specialized medicine being studied to help the body fight off difficult cancers. This medicine is a type of Immunotherapy and Targeted Therapy. It uses the body’s own immune system to find and destroy cancer cells without harming normal cells.

• Generic Name: Live attenuated listeria encoding human mesothelin vaccine CRS 207
• US Brand Names: CRS 207 (Investigational name)
• Drug Class: Cancer vaccine, Immunotherapy, Targeted Therapy
• Route of Administration: Intravenous infusion (given through a vein)
• FDA Approval Status: Investigational (Not yet approved by the FDA for general public use, currently used in clinical trials)
  
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What Is It and How Does It Work? (Mechanism of Action)

This medicine is a bioengineered cancer vaccine. It is made from a live bacteria called Listeria monocytogenes. Scientists have weakened this bacteria in a laboratory so it cannot cause sickness in healthy people. Instead, it acts as a Smart Drug to train your immune system to attack cancer.

Here is how it works inside the body:

The bacteria is built to carry a specific protein called human mesothelin. Mesothelin is a protein that is heavily found on the outside of certain cancer cells, like pancreatic cancer, ovarian cancer, and mesothelioma.

When the medicine is given through a vein, special immune cells called antigen presenting cells swallow the weakened bacteria. Inside these cells, the bacteria releases the mesothelin protein. The immune cells then display pieces of this protein on their outer surface.

This process sounds a loud alarm in the body. It activates a strong army of white blood cells known as cytotoxic T lymphocytes, or killer T cells. These activated T cells learn to recognize the mesothelin protein. They then travel through the body to hunt down and break apart the cancer cells that have mesothelin on them. At the same time, the bacteria itself wakes up the body’s general immune defenses, creating a very strong, double layered attack against the tumor.

FDA-Approved Clinical Indications

Because this medicine is still being tested in clinical trials, it does not have official FDA approval yet. However, it is being heavily studied for the following uses.

Oncological Uses (Investigational):

• Metastatic pancreatic ductal adenocarcinoma (pancreatic cancer that has spread).
• Malignant pleural mesothelioma (cancer of the lung lining).
• Advanced ovarian cancer.
• Non small cell lung cancer.

Non oncological Uses:

• None at this time.

Dosage and Administration Protocols

This medicine is given by a healthcare professional through an intravenous line into a vein. Because it is an investigational drug, doctors follow strict study rules for dosing.

Patients receive medicines like acetaminophen before the infusion to help prevent fever and chills. They are also given extra intravenous fluids before and after the treatment.

Clinical Efficacy and Research Results

Recent clinical studies from 2020 to 2025 have looked closely at how well CRS 207 works, especially for patients with advanced pancreatic cancer. Pancreatic cancer is very hard to treat because it builds a protective wall against the immune system.

In recent phase 2 trials, doctors combined CRS 207 with another cancer vaccine called GVAX and other immunotherapy drugs like nivolumab and ipilimumab. The goal was to see if this combination could shrink tumors better than standard treatments.

The 2025 study results showed that the objective response rate (the percentage of patients whose tumors shrank) was 4 percent. While the tumor shrinkage was small, tests showed that the medicine successfully trained the T cells to recognize the cancer and enter the tumor area.

However, the overall survival time for patients in these studies remained low, averaging between 3.7 to 5.4 months. Researchers discovered that while the medicine brought good immune cells into the tumor, it also brought in some protective cells called myeloid cells that shielded the tumor. Scientists are now working on new ways to block these protective cells so the vaccine can work even better.

Safety Profile and Side Effects

Because this medicine uses live bacteria to wake up the immune system, it causes reactions that often feel like a strong flu.

Common Side Effects (Occurring in greater than 10 percent of patients):

• Chills and severe shivering (happens in nearly all patients)
• High fever
• Feeling very tired (fatigue)
• Nausea and vomiting
• Decreased appetite
• Anemia (low red blood cell count)
• Constipation

Serious Adverse Events:

• Cytokine Release Syndrome: A severe overreaction of the immune system that causes dangerously low blood pressure and trouble breathing.
• Systemic Infection: Because the vaccine is made of live bacteria, there is a small risk of a serious blood infection called listeriosis.

Black Box Warning:

Since this drug is investigational, it does not have a formal FDA Black Box Warning. However, clinical trial warnings state that doctors must monitor patients very closely for Cytokine Release Syndrome and severe infections.

Management Strategies:

Doctors manage fever and chills by giving acetaminophen and ibuprofen. If a patient’s blood pressure drops, the healthcare team will give intravenous fluids right away. If the patient develops signs of Cytokine Release Syndrome, the doctor may use specific medicines to calm the immune system. If a real bacterial infection is suspected, the doctor will give strong antibiotics.

Connection to Stem Cell and Regenerative Medicine (If Applicable)

Research Areas:

While CRS 207 is not a stem cell therapy itself, it is frequently combined with cellular therapies to regenerate a healthy immune response. In clinical trials, it is often paired with GVAX, a whole cell vaccine made from heavily modified human pancreatic cancer cells. GVAX works by changing the tumor microenvironment, making it easier for the immune cells generated by CRS 207 to enter the tumor. This combination is a major step forward in regenerative immune medicine, aiming to rebuild the body’s natural cancer fighting abilities.

Patient Management and Practical Recommendations

Patient safety is the top priority during these clinical trials. Doctors will run several tests to make sure the patient is strong enough for the treatment.

Pre treatment tests to be performed:

• Complete blood counts to check white and red blood cells.
• Comprehensive liver and kidney function tests.
• Blood clotting tests.
• Imaging scans like CT scans to measure the size of the tumors.

Precautions during treatment:

• Patients must stay at the clinic or hospital for several hours or overnight after the infusion to be watched for fever and blood pressure drops.
• Patients with active infections or those taking strong medicines that suppress the immune system cannot receive this treatment.

Do’s and Don’ts List:

• Do drink plenty of fluids before and after your treatment to stay hydrated.
• Do report any dizziness, trouble breathing, or high fever to your doctor immediately.
• Do take the pre treatment medicines given by your nurse to prevent shivering.
• Do not take any new antibiotics without talking to your cancer doctor first, because antibiotics will kill the vaccine bacteria and stop the treatment from working.
• Do not spend time around people who are sick or have weak immune systems right after your treatment.

Legal Disclaimer

The medical information provided in this guide is for educational and informational purposes only and is not meant to replace professional medical advice, diagnosis, or treatment. This medication is currently investigational and has not been approved by the FDA for general use. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or clinical trial options. Do not disregard professional medical advice or delay seeking it because of something you have read in this material.