- Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.
- Encouraging VAXINIA efficacy, including a complete response (CR) and two partial responses (PRs), has warranted cohort expansions in biliary tract cancer and other tumour types.
- Compared to chemotherapy alone, vaccination with HER-Vaxx was associated with a 40% overall survival benefit.
- HER-Vaxx induced HER2-specific antibody levels correlate with tumour reduction.
Imugene Managing Director & CEO
Details on the poster presentations are below:
Presentation Title: Oncolytic virus CF33-hNIS for the treatment of advanced cancer
Abstract Presentation Number: CT182
Session Date and Time:
Session Title: First-in-Human Phase I Clinical Trials 2
Presenter:
Highlights include:
- At the data cut-off of
19 December 2023 , there were 31 efficacy-evaluable patients in the MAST study. In the intratumoural (IT) cohorts, 7 of 16 (44%) injected lesions had a reduction in tumour burden and 3 lesions were completely eradicated. Three of the IT treated patients had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma and 2 partial responses by RECIST in patients with melanoma. In the intravenous (IV) cohorts, 9 of 17 (53%) patients achieved stable disease as their best response. Patients who received prior checkpoint blockade therapy derived clinical benefit with and without pembrolizumab. Viral replication, assessed by SPECT, was higher in patients who had a reduction in tumour burden. - Patients with a higher level of T cell diversity in peripheral blood (pre-treatment) respond better to VAXINIA therapy, consistent with the known mechanism of action of oncolytic virotherapies and their ability to promote an anti-tumour T cell response.
- Both IT- and IV-treated patients have promising immunological changes in on-treatment tumour biopsies (including increases in cancer fighting CD8 T cells and PD-L1 expression) indicated that VAXINIA can transform the tumour microenvironment.
- Several patients have had prior treatment with checkpoint blockade, including a stable disease cholangiocarcinoma patient and two melanoma partial response patients. This suggests that VAXINIA +/- checkpoint inhibitor combination could be used in the checkpoint therapy refractory setting, which is seeing a growing and unmet market in oncology, by altering the tumour microenvironment.
Presentation Title: Frontline vaccination with the B-cell peptide compound HER-Vaxx (IMU-131), combined with standard-of-care chemotherapy induces high levels of HER2-specific antibodies mediating ADCC and intracellular phosphorylation inhibition resulting in overall survival benefit in patients with HER2+ metastatic or advanced gastric/GEJ adenocarcinoma – Final results from Phase II/HERIZON study
Poster Number: CT215
Session Date and Time:
Session Title: Phase II Clinical Trials 1
Presenter:
Highlights include:
- HER-Vaxx treatment produced robust anti-HER2-IgG and IgG1 antibody response (p<0.001).
- HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.
- The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies.
About the MAST Trial
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit cancer patients across approximately 10 trial sites in
The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).” The trial commenced in
Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.
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Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.
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