IMU:
SYDNEY, Australia, 14 July 2020: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company,
today announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx in Australia.
Ethics approval is confirmation Imugene has completed all the necessary pre-clinical safety and efficacy testing of PD1-Vaxx required to commence human clinical trials.
The Australian component of the Phase I trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities.
The first hospital to receive ethics approval is the Chris O’Brien Lifehouse a comprehensive cancer hospital located in Sydney Australia.
Additional clinical sites will be opened in Australia, and also in the US following a Food and Drug Administration (FDA) investigational new drug (IND)
The first-in-human, Phase 1, multi-centre, dose escalation study of PD1-Vaxx will involve patients with non-small cell lung cancer. Medical investigators will test different doses of PD1-Vaxx as a monotherapy and in combination with immune checkpoint inhibitor drugs.
