What is NeoVax? 

Dr. Inhye Ahn from Dana-Farber Cancer Institute in Boston, Massachusetts, is conducting a clinical trial that administers a personalized vaccine for CLL called NeoVax. 

NeoVax helps harness the body’s immune system to fight CLL. It works by sequencing the genetic information of a patient's CLL cells to identify unique mutations, known as neoantigens, produced by the cancer cells. The vaccine incorporates copies of as many as 20 of these neoantigens, which are intended to direct the body's immune response against the cancer cells. 

The process involves scanning the DNA sequence in a patient's cancer cell to identify key epitopes (​​part of a neoantigen, a protein on a cancer cell that causes the body to make an immune response) within the cancer cell neoantigens. These epitopes serve as targets for T-cells, which lead the immune system's attack on cancer. By treating a patient with NeoVax, the epitopes draw an immune system response specifically against any CLL cells containing those mutations, thus aiming to control or eliminate the cancer. 

The vaccine is part of a broader category of treatments known as neoantigen vaccines, which are a promising avenue in cancer immunotherapy. By targeting neoantigens specific to each individual's cancer, these vaccines offer a highly personalized approach to treatment, potentially leading to more effective and lasting responses compared to traditional treatments​​​​.  

How Effective is NeoVax? 

Although there is not yet published data about NeoVax’s efficacy for CLL as the study is in its early stages, the cancer vaccine has shown promising results in other diseases like melanoma, a type of skin cancer. 

In melanoma, researchers found that four years after treatment with NeoVax, all eight patients were alive, six of the patients had no signs of active disease, and the cancer-killing T-cells continued to remember and kill new melanoma cells. 

How is NeoVax for CLL Administered? 

The vaccine is currently being administered in a phase I clinical trial at Dana-Farber Cancer Institute in Boston, Massachusetts. 

“A phase I clinical trial tests the safety, side effects, best dose, and timing of a new treatment. It tests how the treatment affects the body. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Phase I clinical trials usually include only a small number of patients”. Cancer.gov

The vaccine is being administered to higher-risk CLL patients who have unmutated IGHV, don’t qualify to start normal CLL treatments (are in watch and wait), and have not ever received any type of CLL therapy. Over 20 weeks, participants will receive 5 priming doses followed by two booster shots. 

If you participate in the study, you may be placed into one of three groups (cohorts):

• Group A will receive NeoVax and a T-helper peptide (Hiltonol).
• Group B will receive NeoVax, T-helper peptide, and a cancer medicine called low-dose cyclophosphamide.
• Group C will receive NeoVax, T-helper peptide, low-dose cyclophosphamide, and an antibody medicine called pembrolizumab (Keytruda). 

These additional medicines are added in hopes of improving the effectiveness of the treatment. 

To assess treatment effectiveness, at various intervals in the study patients will undergo a CT scan, bone marrow tests (biopsy and aspirate), blood sample collection, and saliva sample collection. 

After the study is completed, patients will receive follow-up every three weeks. 

Click here to read more about the study’s inclusion and exclusion criteria (eligibility requirements to be able to join this study). 

How Can I Receive NeoVax?

If you would like to receive NeoVax inside of the clinical trial, click here and then the “Begin Now” button to receive help from HealthTree Foundation patient navigators who will guide you through the enrollment process. 

One thing to note is that because this is a phase I clinical trial, the few enrollment spots may fill up quickly. However, if the vaccine proves to be effective with manageable side effects, additional phases may open up in the future allowing more CLL patients to receive NeoVax. 

In conclusion, NeoVax is a personalized cancer vaccine that is the first of its kind to be administered to blood cancer patients like CLL. We look forward to future publications about the vaccine in hopes of an effective treatment option for the CLL patient watch and wait population.

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