viewImugene Ltd

Imugene gets development roadmap for cancer vaccine from FDA meeting

The company had a pre-investigational new drug (IND) meeting with the FDA last month.

man in lab coat holding up test tube
The company met with 7 people from the US Food and Drug Administration (FDA)

Imugene Ltd (ASX:IMU) has received minutes of its meeting with the (FDA) for its KEY-Vaxx cancer immunotherapy on 8 February 2019.

The meeting was aimed at seeking guidance on the studies required for phase I clinical development of KEY-Vaxx.

Topics addressed included the anticipated clinical indication and the treatment of cancers that overexpress PD-L1 including but not limited to non-small cell lung cancer.

Imugene’s managing director and CEO Leslie Chong said: “The meeting was productive and provided Imugene with a clear roadmap for a successful IND submission and subsequent clinical development of KEY-Vaxx.

“The FDA panel members encouraged Imugene to pursue the planned IND submission and subsequent clinical studies.”

READ: Imugene doses milestone first patient for cancer vaccine trial

Imugene is developing cancer immunotherapies targeting B-cell peptide vaccines.

Its most advanced drug being developed is HER-Vaxx cancer vaccine.

Last week Imugene dosed its first patient in its phase II study with its HER-Vaxx cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

Quick facts: Imugene Ltd

Price: 0.115 AUD

Market: ASX
Market Cap: $545.21 m

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