Breast Cancer Vaccine Moves into Phase 2 Clinical Trial

HER-Vaxx showed success stimulating the production of HER-2 antibodies in early-stage cancer patients

The use of immunotherapy to develop vaccines against gastric and breast cancers is considered the hottest area of oncology, thanks to the approval of the first cancer cell-killing drug for blockading immune checkpoints.

Immune checkpoint mechanisms in cancer are often activated to suppress nascent anti-tumor immune responses.

In healthy individuals, these immune-checkpoint molecules prevent autoimmune responses and limit immune cell-mediated tissue damage.

A new cancer vaccine candidate, HER-Vaxx, has successfully completed a Phase 1b clinical study, which was an open-label, multicenter dose escalation study designed to assess the safety, tolerability, immunogenicity and recommended phase 2 dose (RP2D) of IMU-131.

HER-Vaxx was developed by researchers at the Medical University Vienna. Imugene partnered with Mymetics in 2014 to manufacture the drug. This partnership has the potential to create game-changing B Cell peptide vaccines that would replace or augment conventional monoclonal antibody therapies.

HER-Vaxx is potentially a more potent alternative to Herceptin and Perjeta

Imugen's chief scientific officer Professor Ursula Wiedermann, who is also the Professor of Tropical Medicine at the Medical University of Vienna, said “An eventual breast cancer vaccine would be like a tetanus booster that is administered every few years.”

According to, HER-2-positive B-cell peptide antigen IMU-131 is a cancer vaccine consisting of a fusion peptide, composed of three peptides derived from the extracellular domain (ECD) of the HER2 peptide antigen found on B-cells (P4, P6 and P7; P467), conjugated to the carrier protein DT-CRM197, a non-toxic, mutated form of diphtheria toxin (DT), and combined with the immunoadjuvant montanide ISA 51, with potential immunostimulatory and antineoplastic activities.

Additionally, Imugene said it will next focus on gastric cancer in a Phase 2 study.

The Phase 2 stage of the trial will include 68 patients with HER2-positive metastatic gastric cancer. The main measurements of the trial will be the vaccine’s safety, ability to provoke an immune response, how long it takes patients’ cancer to progress, and their overall survival.

“The successful start of this study represents an important development milestone for our business and medical professionals seeking new ways to treat patients with gastric cancer,” said Leslie Chong, Imugene’s chief executive officer.

Gastric cancer is the second most common cause of cancer-related death in the world and the fourth most commonly diagnosed cancer, with over 1,000,000 new cases diagnosed each year.

Infection with bacteria called H. pylori is a common cause of gastric cancer, according to

Beyond its HER-Vaxx product holdings, Imugene also owns a drug delivery platform, Linguet, which uses its proprietary technology to improve the efficacy and safety of a diverse number of existing prescription and over-the-counter medicines.