Her-VAXX

P2, N=7, Terminated, Imugene Limited | Completed --> Terminated; Study was discontinued because of slow enrollment and organizational priorities and not because of any findings related to safety or efficacy.

P1/2, N=64, Completed, Imugene Limited | N=36 --> 64

P2, N=7, Completed, Imugene Limited | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Apr 2024

P1/2, N=36, Completed, Imugene Limited | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024

HER-Vaxx plus standard chemotherapy exhibits an excellent safety profile and improves OS. Furthermore, vaccine-induced immune response was significantly associated with reduced tumor size compared to standard-of-care chemotherapy. The presented vaccination approach may substitute for treatment with trastuzumab, upon unavailability or toxicity, based on further evidence of equivalent treatment efficacy.

P1/2, N=36, Active, not recruiting, Imugene Limited | Phase classification: P1b/2 --> P1/2 | Trial completion date: Feb 2024 --> Aug 2024

P2, N=7, Active, not recruiting, Imugene Limited | Recruiting --> Active, not recruiting | N=30 --> 7

Her-2/neu-targeting therapy by passive application with trastuzumab is associated with acquired resistance and subsequent metastasis development, which is attributed to the upregulation of tumoral PD-L1 expression and the downregulation of Her-2/neu...The downregulation of Her-2/neu and the upregulation of PD-L1 were observed in a patient's primary tumor at the disease progression time point but not prior to vaccination (Her-2/neu IHC: 3 to 0, FISH: 4.98 to 1.63; PD-L1 CPS: 0% to 5%). Our results further underline the need for combination therapy by targeting PD-L1 to prevent metastasis formation and immune evasion of Her-2/neu-positive and PD-L1-negative tumor cells.

Background HER-Vaxx is a B cell peptide-based anti-Her2 vaccine (IMU-131) comprising B cell epitopes located within trastuzumab's binding site...Chemotherapy consisted of oxaliplatin plus capecitabine and was started at day 0, repeated q. 21 days for a maximum of 6 cycles...Moreover, the vaccine-induced IgG antibodies had the capacity to inhibit intracellular phosphorylation of Her2 and exhibited binding to the gastric cancer cell line N87 overexpressing Her2. Conclusions Vaccination with HER-Vaxx in patients with Her2-overexpressing GC at doses of 50μg and 100μg led to an anti-tumour effect that correlated with anti-Her2 IgG antibody levels.

P2, N=30, Recruiting, Imugene Limited | Trial completion date: Nov 2025 --> Jul 2026 | Trial primary completion date: Jul 2023 --> Mar 2024

HER-Vaxx is a B cell peptide-based anti-Her-2/neu vaccine (IMU-131) comprising trastuzumab's binding site...Chemotherapy consisted of oxaliplatin plus capecitabine and was started at day 0, repeated q. 21 days for a maximum of 6 cycles... HER-Vaxx-based vaccination of patients with Her-2 overexpressing GC-induced anti-Her-2-IgG and -IgG1 subclass antibody responses and the magnitude of these antibody responses (total IgG and IgG1) correlated with tumor size reduction. The present data, its previously shown favorable safety profile as well as improved overall survival data induced by HER-Vaxx in Her-2/neu overexpressing GC validate the proof of concept for a first-in-class B-cell immunotherapy based on Her-2/neu peptides.

P1b/2, N=36, Active, not recruiting, Imugene Limited | Trial completion date: Feb 2022 --> Feb 2024 | Trial primary completion date: Jan 2022 --> Jan 2024