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Imugene doses first patient with HER-Vaxx in nextHERIZON Phase 2 clinical trial - Kalkine Media

September 08, 2022 02:45 PM AEST | By Aditi Sarkar
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Highlights

  • Imugene has completed dosing the first patient in the nextHERIZON Phase 2 clinical trial in HER-Vaxx, IMU’s cancer immunotherapy
  • The clinical trial is focused on studying HER-Vaxx in combination with chemotherapy or pembrolizumab in patients diagnosed with HER-2+ gastric cancer
  • Imugene plans to open further study sites in Australia and the USA

Imugene Limited (ASX:IMU) takes another step toward developing its immunotherapy candidate HER-Vaxx.  In an upbeat announcement, the clinical-stage immuno-oncology company reported that it had completed dosing the first patient in the nextHERIZON Phase 2 clinical trial in HER-Vaxx.

Following the news, shares of the company climbed nearly 5.7% to AU$0.232 during Thursday morning trading hours.

Imugene’s HER-Vaxx is a cancer immunotherapy that activates B-cells to generate antibodies targeting HER-2+ gastric cancer. It is conducted to treat tumours overexpressing the HER-2/neu receptor, such as breast, gastric, lung, ovarian and pancreatic cancers.

The nextHERIZON Phase 2 clinical trial is focused on studying HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with HER-2+ gastric cancer. It is an open-label, signal-generating, multi-centre, Phase 2 clinical trial. The trial commenced recently after the company gained ethics approval. Following are the goals of the study:

  • Primary goal – safety and response rate
  • Secondary goal – progression-free survival, duration of response, biomarker evaluation and overall survival

The investigation is led by Principal Investigator, Professor Tim Price. Under his guidance, the first patient was dosed at the Queen Elizabeth Hospital in Adelaide, Australia.

Imugene plans to open further study sites in Australia and the USA as well. In December 2021, it received approval from the Food and Drug Administration (FDA) for an investigational new drug (IND).

According to M.D. & CEO of Imugene, Ms Leslie Chong, the company is eager to take the next step in developing HER-Vaxx with this trial, as it has received promising results so far. 

Update on new Oncolytic Virus, VAXINIA

Earlier this month, Imugene announced the clearing of the intratumoral (IT) cohort 1, leading to the opening of cohort 2 for IT administration in its Phase 1 MAST (metastatic advanced solid tumours) study of CF33-hNIS (VAXINIA). VAXINIA is a novel cancer-killing virus and the study is focused on evaluating its safety.


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