On December 5, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported positive new data regarding overall survival results in its HER-Vaxx HERIZON study as provided in an oral presentation at the ESMO (Free ESMO Whitepaper) Asia Congress 2022 held in Singapore (Press release, Imugene, DEC 5, 2022, View Source [SID1234624757]).
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Speaking to the Congress on Sunday 4 December 2022, principal investigator Marina Maglakelidze outlined
the study design, information regarding demographics and characteristics of the 36 patients in the trial,
and data covering safety and adverse events.
Key conclusions of the overall survival benefit of HER-Vaxx included:
• HER-Vaxx + chemotherapy showed a statistically significant 42% overall survival benefit compared
to chemotherapy alone (13.9 vs 8.3 months)
• Duration of response is longer in the HER-Vaxx + chemotherapy arm over chemotherapy alone (30
vs 19 weeks)
• Vaccination with HER-Vaxx induced persistent HER-2 specific antibodies which correlated with
clinical response as proof of concept for a first-in-class B-cell immunotherapy based on HER-2
peptides
• No significant additive toxicity was seen when HER-Vaxx was administered in combination with
chemotherapy
The full presentation provided at ESMO (Free ESMO Whitepaper) can be viewed at: View Source
The oral presentation and abstract, number 74MO, was titled ‘HERIZON Overall Survival Results: A study of
IMU-131, a HER2 Targeting Peptide Vaccine, Plus Standard of Care Chemotherapy in Patients with HER2
Overexpressing Metastatic or Advanced Gastric/GEJ Cancer’.
The HERIZON study was a Phase 2 clinical trial of Imugene’s HER-Vaxx technology in Her-2/Neu
overexpressing advanced/metastatic gastric/GEJ cancer. HER-Vaxx is a B-cell activating cancer
immunotherapy designed to treat tumours that overexpress 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 HER2/neu.