NeuVax (nelipepimut-S) is an investigational immunotherapy being developed by Galena Biopharma to treat human epidermal growth factor 2 (HER2)-associated breast cancers.

How NeuVax works

NeuVax is a cancer vaccine, meaning that it acts to “educate” the immune system to recognize and mount a response against specific tumor-associated antigens (TAAs). Antigens are substances that are associated with a disease and not normally found in the body.

Many breast cancer cells produce a protein called the HER2 protein, which promotes cell growth. NeuVax contains peptides, or small parts of a protein, derived from HER2. These are called E75.

When NeuVax is injected into a patient’s body, the immune system recognizes these peptides as an antigen. This stimulates the production of a type of “killer” immune cells called cytotoxic T lymphocytes (CTLs), which are designed to identify and destroy tumor cells expressing the HER2 antigen.

NeuVax is given alongside Leukine (sargramostim or GM-CSF), which can boost the number of immune cells in the body and increase the anti-tumor activity of the vaccine.

NeuVax in clinical trials

An initial Phase 1/2 clinical trial (NCT00841399) to assess the safety, maximum tolerated dose, and immune response associated with NeuVax was carried out in 100 patients with breast cancer in the U.S. The results were published in the scientific journal Annals of Oncology, alongside data from a second trial in 95 patients. The most common side effects associated with the treatment were mild injection site reactions, fatigue, bone pain, and flu-like symptoms.

A Phase 3 trial (NCT01479244) assessing the safety and effectiveness of NeuVax plus Leukine in early-stage breast cancer patients with low to intermediate HER2 was discontinued in 2016, based on a recommendation from the Independent Data Monitoring Committee during a planned interim futility analysis. NeuVax continues to be investigated in other indications and in combination with other drugs.

Two Phase 2 clinical trials are being carried out by Cancer Insight in collaboration with both Galena and Genentech. These trials aim to assess the safety and effectiveness of NeoVax with Leukine alongside Genentech’s Herceptin (trastuzumab) compared to Herceptin and Leukine alone. On Sept. 28, 2017, Galena announced that both trials were fully enrolled and that both were successfully deemed non-futile and safe to continue during the planned interim analysis stage.

The first Phase 2 trial (NCT01570036) has recruited 300 patients with HER2 1+/2+ breast cancer at 32 sites across the U.S.

The second Phase 2 trial (NCT02297698) has recruited 100 high-risk HER2 3+ breast cancer patients at 26 sites across the U.S. Results from an interim analysis were announced in April 2017, suggesting that NeuVax was well-tolerated and no significant difference in the level of side effects has been observed between the two treatment groups. The study is estimated to be completed by October 2019.

A Phase 2 trial (NCT02636582) called VADIS is assessing NeuVax alongside Leukine as a treatment for ductal carcinoma in situ (DCIS). The trial is being carried out by the National Cancer Institute (NCI) and is still recruiting participants at four sites across the U.S.

Galena also intends to investigate NeuVax as a treatment for stomach (gastric) cancers. A Phase 2 clinical trial is planned in collaboration with Dr. Reddy’s Laboratories in India.

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