About the PRESENT Trial

Are you a breast cancer patient interested in participating in a clinical trial that may prevent breast cancer from returning?

Currently Enrolling

We are currently enrolling breast cancer patients for the NeuVax™ Phase 3 PRESENT (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment) study, an investigational drug trial to evaluate the effectiveness of the NeuVax™ (nelipepimut-S) vaccine to prevent or delay breast cancer recurrence after standard of care treatment (chemotherapy, hormone therapy, radiation therapy).

What This Means for You

The PRESENT trial is designed to fight the recurrence of breast cancer in patients after the standard of care treatment. As a participant in the PRESENT trial, you will go through two stages of treatment:

• An intradermal injection once per month for six months (6 total), followed by
• Booster shots once every six months for 30 months (5 total)

By the end of your treatments, you will have received a total of 11 shots over the course of three years.

About NeuVax™

NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.

About the Phase 3 Trial

Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for HER2 (IHC 1+, 2+ or 3+). NeuVax targets approximately 50-60% of HER2-positive patients (IHC 1+/2+ or FISH <2.2) who achieve remission with current standard of care treatment, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

Download Patient Brochure