Imugene Ltd (ASX:IMU, OTC:IUGNF) is trading higher on fielding positive final overall survival data from its Phase 2 study of HER-Vaxx, which targets Her-2/Neu-overexpressing advanced or metastatic gastric cancer.
Patients treated with HER-Vaxx for the longest remain alive 2.5 years after starting therapy, with one patient approaching three years.
The company notes that these patients generated the strongest anti-Her-2 antibody levels from their dosing schedule on HER-Vaxx.
Investors welcomed the news with shares as much as 47% higher to A$0.2425 while the company's market cap is approximately A$1.32 billion.
Favourable survival
Analysis of safety and efficacy data in the randomised Phase 2 trial showed an overall survival Hazard Ratio (HR) of 0.585 (80% two-sided CI: 0.368, 0.930) with a statistically significant p-value of 0.066.
What’s more, the company’s asset showed a reduced risk of death of 41.5% in the HER-Vaxx plus chemotherapy group compared to those treated with standard-of-care (SOC) chemotherapy alone.
The trial confirms a favourable survival outcome with no added toxicity for HER-Vaxx combined with standard-of-care (SOC) chemotherapy over chemotherapy alone.
Significant milestone
Imugene MD and CEO Leslie Chong said: “I am delighted to report that we have achieved this significant milestone for patients with advanced gastric cancer.
“The final analysis favoured the survival outcome for HER-Vaxx and I note the Independent Data Monitoring Committee previously suggested to shorten the study by lowering the number of patients.”
Higher dose approved for next study
Imugene also welcomes news that the Cohort Review Committee (CRC) involved in the trial has approved a new higher dose of HER-Vaxx (100µg) for use in for two upcoming gastic cancer trials due to kick off soon – the nextHERIZON (pretreated metastatic HER2 positive gastric cancer) and neoHERIZON (perioperative HER2 positive gastric cancer) studies.
The CRC unanimously agreed that HER-Vaxx at 100µg is safe, with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed.
The higher dose is expected to accelerate and strengthen antibody generation, which will bolster the clinical response for HER-Vaxx.
Delivery of large-scale batch
The company has taken delivery of a new clinical batch, which was manufactured to supply all planned HER-Vaxx clinical trials in 2022.
“Reliability of drug supply is a major hurdle for clinical development of many modern biological oncology drug candidates,” said Chong.
“De-risking this critical component of clinical development is a significant achievement for Imugene.”