ITI-5000 Vaccine + Pembrolizumab for Breast Cancer

(VITAL-TNBC Trial)

This trial tests a new cancer vaccine, ITI-5000, to determine if it can help the immune system attack triple-negative breast cancer (TNBC) cells. The vaccine trains the body to target specific proteins on these cancer cells. The study consists of two parts: the first tests different doses of the vaccine alone, and the second combines the optimal dose with an existing immunotherapy drug, pembrolizumab. Ideal participants have completed standard treatments for early-stage TNBC within the last 36 months and have no major heart issues or active autoimmune diseases. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use alternative therapies during the study and must avoid certain vaccines close to the trial period.

Research has shown that ITI-5000, an experimental cancer vaccine, is being tested for safety and effectiveness in working with the immune system. Although specific safety details for ITI-5000 are not yet available, it is based on a method similar to approved mRNA vaccines, which are generally well-tolerated.

In animal studies, ITI-5000 demonstrated greater effectiveness without additional safety concerns, suggesting potential safety for humans. However, ongoing trials are needed to provide more information.

Unlike the standard treatments for breast cancer, which often include chemotherapy, hormone therapy, and targeted therapies, the ITI-5000 mRNA vaccine offers a novel approach by using mRNA technology to stimulate the body's immune system to target cancer cells. Researchers are excited about this treatment because it harnesses the body’s natural defenses and could potentially provide a more precise attack on cancer cells with fewer side effects. Additionally, when combined with pembrolizumab, an immune checkpoint inhibitor, this treatment aims to enhance the immune response even further, offering a promising new avenue for patients who might not respond to conventional therapies.

Research has shown that the ITI-5000 vaccine may help fight triple-negative breast cancer (TNBC) by training the immune system to attack cancer cells with specific proteins. Studies have found that the vaccine can generate strong immune responses, with many patients experiencing significant tumor reduction and longer survival. In this trial, some participants will receive ITI-5000 as monotherapy, while others will receive it in combination with pembrolizumab, a well-known cancer drug. This combination has demonstrated improvements in keeping patients cancer-free. In some cases, similar vaccine and drug combinations have led to a 49% decrease in cancer recurrence or mortality. This suggests that ITI-5000, especially when combined with pembrolizumab, might effectively reduce cancer recurrence in TNBC patients.¹²³⁶⁷