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.