Imugene kicks off IND process for HER-Vaxx
Imugene (ASX:IMU) has commenced the process of preparing an Investigational New Drug (IND) application in the US for cancer vaccine HER-Vaxx.
The company has appointed Ground Zero Pharmaceuticals (GZP) to manage the application to the US FDA.
The application will require the submission of manufacturing data, animal testing results, clinical safety and efficacy data generated to date and other information including a clinical development plan.
Imugene Executive Director Nick Ed said the filing of the IND will be “an important milestone” in the clinical development of the therapeutic vaccine.
“A successful IND can set the guidance for a key efficacy trial ... and even reduce the time and risk involved in seeking FDA approval,” he said. “It may also allow for the inclusion of additional patients with other indications who may have a chance to benefit from the new drug.”
HER-Vaxx is designed to stimulate a polyclonal antibody response to cancer biomarker HER-2/neu. Imugene aims to develop the drug as a natural, potentially more potent alternative to Roche’s Herceptin, which targets the same biomarker. Herceptin takes in around US$6.9 billion ($7.6 billion) per annum.
The drug has been through a phase I trial in breast cancer and Imugene is preparing a phase II study in gastric cancer.
Imugene acquired HER-Vaxx through the acquisition of Biolife Science in an all-stock deal announced last year.
Imugene (ASX:IMU) shares were trading 6.67% lower at $0.014 as of around 1 pm on Tuesday.
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