HER-Vaxx (IMU-131) is a B-cell peptide immunotherapy cancer vaccine candidate which is 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).
HER-Vaxx is a cancer vaccine candidate designed to treat tumors that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
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 completion of Phase 1b.
Phase 2 will be designed to further characterize the safety and to explore 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.