HER-Vaxx Cancer Immunotherapy
Imugene's HER-Vaxx (IMU-131) is a B-cell peptide 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 (P467). 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 preclinical studies and in a 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 company says that the unique platform technology seeks to harness and promote the body's immune system against cancerous tumors.
The most significant recent development is the presentation and publication of final results from the Phase II HERIZON trial (NCT02795988), a randomized study comparing HER-Vaxx plus standard-of-care (SOC) chemotherapy versus SOC chemotherapy alone in patients with HER2-positive advanced gastric cancer. Presented at ESMO 2024 (and referenced in 2025 publications/conferences): Overall survival (OS) improved significantly: Median OS was 13.9 months with HER-Vaxx + chemo vs. 8.3 months with chemo alone (HR 0.60, p=0.008); Progression-free survival (PFS) showed a 20% improvement (HR 0.80); Tumor size reduction correlated with vaccine-induced immune responses (higher antibody levels linked to better outcomes); Safety: Well-tolerated with no added toxicity beyond standard chemo; manageable side effects and good immunogenicity. Conclusions: HER-Vaxx plus standard chemotherapy exhibits an excellent safety profile and improves OS. Furthermore, the vaccine-induced immune response was significantly associated with a reduction in tumor size compared with standard-of-care chemotherapy. The presented vaccination approach may substitute for trastuzumab treatment when unavailable or toxic, based on further evidence of equivalent efficacy.
Imugene Limited is a clinical-stage immuno-oncology company developing a range of new treatments that aim to activate the immune system of cancer patients to identify and eradicate tumors. It is 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
April 9, 2024 - Imugene Limited announced a poster presentation at the American Association for Cancer Research annual meeting featuring its CF33 oncolytic virotherapy, VAXINIA, and B-cell immunotherapy, HER-Vaxx. Compared with chemotherapy alone, vaccination with HER-Vaxx was associated with a 40% improvement in overall survival.
July 5, 2021 - Data presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer meeting showed that Imugene's HER-Vaxx vaccine program had a statistically significant overall survival of 58.2% compared 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 the overexpresses HER-2 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.