listeria monocytogenes llo psa vaccine adxs31 142

Drug Overview

Listeria monocytogenes LLO PSA vaccine ADXS31 142 is a new type of medicine that helps the body fight cancer. This medicine is a special kind of Immunotherapy and Targeted Therapy. It uses the body’s own immune system to find and destroy cancer cells.

• Generic Name: Listeria monocytogenes LLO PSA vaccine ADXS31 142
• US Brand Names: ADXS PSA (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 use, currently 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 but weakened bacteria called Listeria monocytogenes. Scientists changed the bacteria so it cannot cause sickness in healthy people. Instead, it works as a Smart Drug to train your immune system.

Here is how it works inside the body:

The bacteria is built to carry a protein called human prostate specific antigen, or PSA. PSA is a protein found on prostate cancer cells. It also carries a piece of a protein called listeriolysin O, or LLO, which wakes up the immune system.

When the medicine enters the bloodstream, special immune cells called antigen presenting cells swallow the bacteria. Inside these cells, the PSA and LLO proteins are chopped into tiny pieces. These pieces are then shown on the outside of the immune cells using special receptors called Major Histocompatibility Complex I and II.

This process sounds an alarm in the body. It activates an army of white blood cells called T lymphocytes. These T cells are now trained to hunt down and destroy any cancer cell that has PSA on it. At the same time, the medicine blocks bad immune cells, like T regulatory cells and myeloid derived suppressor cells, which usually protect the tumor. By blocking the bad cells and boosting the good cells, the medicine causes the tumor cells to break apart and die.

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 studied for specific uses.

Oncological Uses:

• Investigational treatment for metastatic castration resistant prostate cancer (advanced prostate cancer that has spread and no longer responds to hormone therapy).

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. Since it is still in clinical trials, doctors are testing different doses. The standard doses used in recent studies like the KEYNOTE 046 trial are shown below.

If a patient has severe reactions, the doctor will pause the treatment. Because this drug uses live bacteria, special care is taken to make sure the body can handle it.

Clinical Efficacy and Research Results

Recent clinical studies from 2020 to 2025, specifically the KEYNOTE 046 phase 1 and 2 trial, have shown how well this medicine works for men with advanced prostate cancer.

When the medicine was given alone, patients had a median overall survival of 7.8 months. The time before the disease got worse was 2.2 months.

When the medicine was given in combination with another immunotherapy drug called pembrolizumab, the results were much better. Patients who received the combination had a median overall survival of 33.7 months. The time before the disease got worse increased to 5.4 months.

In the combination group, about 43 percent of patients saw a decrease in their PSA levels. Also, patients who had previously received strong chemotherapy like docetaxel still lived an average of 16 months longer. These numbers show that combining this vaccine with other immunotherapies is very promising for extending the lives of patients with advanced prostate cancer.

Safety Profile and Side Effects

Like all medicines, this cancer vaccine can cause side effects. Because it wakes up the immune system, many side effects feel like the flu.

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

• Chills and shivering
• Fever
• Low blood pressure (hypotension)
• Nausea
• Feeling very tired (fatigue)

Serious Adverse Events:

• Severe allergic reactions or immune system overreactions (cytokine release).
• Listeremia: Because the medicine contains live bacteria, there is a small risk of a bacterial infection in the blood.

Black Box Warning:

Because the medicine is not FDA approved, it does not have an official Black Box Warning. However, clinical trial warnings state that doctors must watch closely for severe infections and immune system overreactions.

Management Strategies:

If common side effects like fever or chills occur, doctors can give medicines like acetaminophen or extra fluids. If blood pressure drops, IV fluids and close monitoring are required. If a doctor suspects listeremia or a serious bacterial infection, they will stop the treatment and give antibiotics immediately.

Connection to Stem Cell and Regenerative Medicine

Research Areas:

While this specific vaccine is not directly made from stem cells, it is a major part of the growing field of regenerative immune medicine and Immunotherapy. Current research focuses heavily on combining this vaccine with other advanced treatments, such as immune checkpoint inhibitors like pembrolizumab. Scientists are exploring how training the immune system with this bacterial vaccine can regenerate a healthy immune response in the tumor microenvironment. There are also ongoing studies looking at how this technology might work alongside other cellular therapies to better target solid tumors.

Patient Management and Practical Recommendations

Before and during treatment, doctors will closely manage the patient’s care to keep them safe.

Pre treatment tests to be performed:

• Complete blood counts to check white blood cell levels.
• Liver and kidney function tests.
• Blood pressure and heart rate checks.
• Tests to measure PSA levels in the blood to see how the cancer is responding.

Precautions during treatment:

• Patients must be watched for at least a few hours after the infusion to check for fever, chills, or low blood pressure.
• Patients with very weak immune systems or active infections should not receive this live bacteria vaccine.

Do’s and Don’ts List:

• Do tell your doctor immediately if you feel dizzy, very hot, or have severe shaking after the infusion.
• Do drink plenty of water to stay hydrated.
• Do keep all of your follow up appointments and blood test dates.
• Do not start any new antibiotics without telling your cancer doctor, as antibiotics can kill the weakened bacteria in the vaccine and make it stop working.
• Do not be around people who are very 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 treatment options. Do not disregard professional medical advice or delay seeking it because of something you have read in this material.