Novel HER2 Vaccine Shows Efficacy, Safety in Early Clinical Trial

By David Costill
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Imugene recently announced that its investigational Human Epidermal Growth Factor Receptor 2 (HER2) vaccine demonstrated positive safety results and promising efficacy data in an early clinical trial.

According to the press release, HER-Vaxx concluded phase1b clinical trials after demonstrating that the vaccine was safe and tolerable in 10 patients receiving chemotherapy for HER2/Neu overexpressing metastatic or advanced cancer.


HER2 vaccine. Source: Getty

Patients received one of three dose levels, either 10 micrograms, 30 micorgrams, or 50 micrograms while also receiving standard of care. Standard treatment included chemotherapy, cisplatin and fluorouracil or capecitabine.

The researchers found that all three dose levels demonstrated increased antibody response in patients. Further, 5 of the 10 evaluated patients showed a partial response and 4 patients showed stable disease.

“With these early results from the HER-Vaxx clinical study, Imugene’s B-cell active immunotherapy approach is showing positive signs which provides us with further confidence in our B-cell immunotherapy pipeline,” Leslie Chong, managing director and CEO of Imugene, said in the press release. “This is a promising milestone for Imugene and the many medical professionals seeking treatments for patients with advanced gastric cancer who often have very few medical options.”

The vaccine works by producing an antibody response against the HER-2 growth protein.

The clinical trials also demonstrated that the vaccine was safe and tolerable in this patient population, with no safety issues reported.

“Together we are cautiously encouraged by meeting all the endponts of the study and data from the top-line results in a small sample size, in particular the five patients whose best response showed more than 30% decrease in their tumor size from baseline scans,” Chong said.

The vaccine will now be tested in phase 2 clinical trials to measure overall survival and progression free survival in 68 patients with HER2/Neu overexpressing metastatic or advanced cancer.