HER-Vaxx Cancer Vaccine Published New Clinical Data

Imugene Limited HER-Vaxx (IMU-131) is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor

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An Australian clinical stage immuno-oncology company announced new clinical data from the Phase Ib study of its HER-Vaxx (IMU-131) cancer vaccine candidate, plus chemotherapy. 

Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine designed to treat tumors that over-express the HER-2/neu receptor, such as gastric cancer. 

This new clinical study data is showing HER-Vaxx’s cancer-fighting antibody and clinical response rates continue to be positive in the patients receiving the optimal biological dose of vaccine.   

On July 8, 2019, Imugene Limited said in a press release that ‘patients have maintained strong and high levels of HER-2 targeting antibodies indicating a durable response is present, with no resistance developed.’ 

In this small study, the cohort 3 patients who received the optimal biological dose, and selected Phase 2 dose, have realized positive trends. 

One patient has seen a total tumor reduction of almost 80 percent from baseline CT scan, with 1 out of 4 of their lesions becoming unmeasurable by RESIST criteria, on Day 266. 

The Phase 1b HER-Vaxx study in metastatic gastric cancer patients overexpressing the HER-2 protein completed enrollment in late 2018 and reported no safety or toxicity issues. All evaluable patients showed increased antibody responses. 

This study is important since gastric cancer is the 5th most frequently diagnosed cancer.

HER-2/neu is overexpressed in 15 to 25 percent of patients with gastric cancer and associated with a poor prognosis, and death, says the National Cancer Insitute.   

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Imugene Managing Director and CEO Leslie Chong said in a press release, “This presentation from the HER-Vaxx Phase 1b study further reinforces the very good early results and ongoing interest among the international oncology community in our potentially promising B-cell platform cancer vaccine and clinical development strategy.” 

The Phase 2 study began enrollment in March 2019 and is scheduled to complete in 2020.

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The positive new data was presented to international delegates at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, in Spain.

The oral presentation was delivered by Dr. Marina Maglakelidze from the Research Institute of Clinical Medicine in Tbilisi, Georgia.

The presentation is titled: ‘A phase 1b study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.’

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors.

For further information please contact: Leslie Chong Managing Director and Chief Executive Officer T: +61 458 040 433 E: [email protected]