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Dirk Arnold, Director of the Asklepios Tumorzentrum in Hamburg Source: European Society for Medical Oncology
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  • Imugene (IMU) secures a new clinical trial supply agreement with Pfizer Inc and Merck KGaA, Darmstadt to treat patients with HER-2 positive gastric cancer
  • The randomised, Phase 2 clinical trial will evaluate the safety and efficacy of Imugene’s HER-Vaxx in combination with chemotherapy and avelumab, an immune checkpoint inhibitor
  • The agreement is effective immediately, with Imugene set to fund the study from existing budgets and resources
  • Imugene shares last traded at 57.5 cents on November 15

Imugene (IMU) has secured a new clinical trial supply agreement with Pfizer Inc and Merck KGaA, Darmstadt.

The agreement will evaluate the safety and efficacy of Imugene’s HER-Vaxx in combination with avelumab, an immune checkpoint inhibitor, in patients with HER-2 positive gastric cancer.

HER-Vaxx is Imugene’s B-cell peptide cancer immunotherapy designed to treat tumours that overexpress the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Avelumab, which is marketed as BAVENCIO, was co-developed and commercialised by Merck and Pfizer. The two parties have agreed to provide avelumab for the duration of the study.

The trial is a randomised, Phase 2 clinical trial with the study’s primary endpoint being pathologic complete response. The study will assess the response of HER-Vaxx in combination with chemotherapy – with or without avelumab – in patients with HER-2 positive gastric cancer.

Imugene said moving HER-Vaxx into earlier gastric cancer in combination with chemotherapy or an immune checkpoint inhibitor may improve treatment outcomes for patients with HER-2 positive gastric cancer, which is considered difficult to treat.

“We are very excited for the opportunity to treat patients with this new generation of HER-2 targeted Bcell immunotherapy, which has the potential to address significant unmet need in early HER-2 overexpressing gastric cancer that remains a challenging indication with poor prognosis,” said Dirk Arnold, Director of the Asklepios Tumorzentrum in Hamburg.

“The combination of chemotherapy and HER-Vaxx alone or in combination with avelumab in this type of gastric cancer may support a better treatment outcome for patients.”

With the agreement effective immediately, Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources.

Imugene shares last traded at 57.5 cents on November 15.

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