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Imugene obtains FDA guidance for KEY-Vaxx immunotherapy clinical development plan

Imugene Ltd (ASX:IMU) managing director & CEO Leslie Chong updates Proactive Investors on the clinical-stage immuno-oncology company’s development of its KEY-Vaxx cancer vaccine.
 
The company had a pre-investigational new drug meeting with the US Food and Drug Administration (FDA) to obtain regulatory guidance and agreement on the preclinical chemistry and controls for KEY-Vaxx’s clinical development plan. 
 
“They approved everything we wanted to do and even ratcheted us back from doing some of the tests because it wasn’t necessary,” says Chong. 
 
She continues, “given that the FDA fully approved our pre-clinical plan, it really bodes well for the safety of this drug.”
 
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