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.
The dosage of HER-Vaxx is being evaluated in ongoing clinical trials
October 1, 2019: Imugene 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 for a minimum time period’.
An open-label Phase II study of HER-Vaxx in 68 patients with metastatic gastric cancer over-expressing the HER-2 protein was initiated in March 2019 and the company aims to complete the study in 2020.
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.