Imugene Ltd’s (ASX:IMU) (OTCMKTS:IUGNF) Phase 1b clinical trial data for its B cell peptide cancer immunotherapy HER-Vaxx has been published in the prestigious American Association for Cancer Research journal Clinical Cancer Research.
The article - 'Clinical and immunologic responses to a B-cell epitope vaccine in HER2/neu overexpressing advanced gastric cancer patients - results from Phase 1b trial IMU.ACS.001' - is authored by Professor Dr Ursula Wiedermann from the Medical University Vienna and study investigators.
HER-Vaxx well-tolerated and safe
Induced HER2-specific antibodies and cellular responses were dose-dependent and correlated with clinical responses.
The highest dose (50 μg) was recommended for further evaluation in a Phase II trial, with chemotherapy + HER-Vaxx or chemotherapy alone, which is currently in its final stages of completion.
Progression-free survival (PFS) was prolonged in cohort 3, correlating with the vaccine-specific humoral and cellular responses.
The important clinical endpoint of PFS was met after the statistically significant required number of PFS events has occurred.
Data from these 24 events will now be analysed with the final PFS readout expected within months.
Designed to treat cancerous tumours
HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The immunotherapy 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 1b and 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.