HER-Vaxx Immunotherapy Description

Imugene's HER-Vaxx (IMU-131) is a B-cell peptide immunotherapy cancer vaccine candidate constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. The three B-cell epitope peptides (P4, P6, and P7) are combined in a specific order resulting in a single fusion peptide of 49 amino acids in length (P467).

The unique platform technology seeks to harness and promote the body’s immune system against cancerous tumors, says the company.

HER-Vaxx is a B-cell immunotherapy designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung, and pancreatic cancers. Developed by leading scientists at the Medical University of Vienna in Austria, the immuno-therapy is constructed from several B-cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies, and in Phase I study to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

B-cell immunotherapies link an immunogenic protein with a B-cell epitope and incorporate an adjuvant to produce a B-cell cancer vaccine that induces the body to produce antibodies against the normal self-proteins, such as HER2 or PD-1 (known as breaking immune tolerance). The antibodies produced following the vaccination are a ‘polyclonal’ mixture of antibodies that bind to different parts of the vaccine antigen. This makes them somewhat different from the monoclonal antibody drugs, even though they bind to the same target in the body.

The use of B-cell immunotherapies to stimulate the patient’s immune system to produce polyclonal antibodies may have advantages over synthetic antibodies, including lower production costs. In addition, B-cell immunotherapies are much cheaper to manufacture than mAb drugs.

Imugene Limited is a clinical-stage immuno-oncology company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors., located at 37 Bligh Street, Suite 1006, Level 10, Sydney, NSW, 2000 Australia.

HER-Vaxx Immunotherapy Indication

HER-Vaxx is a cancer vaccine candidate designed to treat tumors that over-express the HER-2/neu receptor.

HER-Vaxx Immunotherapy Dosage

The dosage of HER-Vaxx is being evaluated in ongoing clinical trials.

HER-Vaxx Immunotherapy News Updates

July 5, 2021 - Data presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer meeting showed Imugene’s HER-Vaxx vaccine program showed a statistically significant overall survival of 58.2% compares to chemotherapy alone. 

April 21, 2021 - The Phase 2 HER-Vaxx study announced positive results. The 36-patient trial met its secondary endpoint of improving progression-free survival.

January 7, 2021 - The Phase 2 study recruitment was completed.

October 1, 2019 - Imugene Limited announced comprehensive clinical data results from the Phase Ib clinical study of its HER-Vaxx anti-cancer vaccine. The data showed a 100% objective response rate in three patients who received the optimal dose of 50 micrograms. The FDA definition of objective response rate is the ‘proportion of patients with tumor size reduction of a predefined amount and a minimum time period.’ An open-label Phase II study of HER-Vaxx in 68 patients with metastatic gastric cancer over-expressing the HER-2 protein was initiated in March 2019. The company aims to complete the study in 2020.

Clinical Trials

Clinical Trial NCT02795988: A Study of IMU-131 (HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer

• The Phase 1b study aims to determine the safety and tolerability of IMU-131 and identify the Recommended Phase 2 Dose (RP2D) of IMU-131 in combination with chemotherapy in HER2/neu overexpressing ACS to carry into the Phase 2 dose-expansion study.
• The Phase 2 component will be submitted as an amendment and will be initiated following Phase 1b.
• Phase 2 will be designed to characterize the safety further and explore the clinical activity of IMU-131 in combination with chemotherapy in HER2/neu overexpressing ACS.
• The Phase 2 study is a randomized, open-label comparison of IMU-131 plus standard of care chemotherapy versus standard of care chemotherapy alone.