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

Last updated: 20:19 19 Mar 2019 EDT, First published: 05:19 19 Mar 2019 EDT

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.”

Imugene with Proactive at ASX Small and Mid Cap Conference

Imugene Ltd (ASX:IMU, OTC:IUGNF) CEO and managing director Leslie Chong chats with Proactive's Jonathan Jackson live from the ASX Small and Mid Cap Conference in March 2024. The biotech stock is a clinical-stage immuno-oncology company that's developing a range of new and novel immunotherapies...

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