Ethics approval is confirmation that Imugene has completed all necessary pre-clinical safety and efficacy testing of PD1-Vaxx required to begin human clinical trials.
This 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 second hospital to receive ethics approval is the Macquarie University hospital in Sydney, Australia.
Additional clinical sites will be opened in Australia and in the US following a Food and Drug Administration (FDA) investigational new drug (IND) submission.
Managing director and CEO Leslie Chong said: “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of lung cancer.
“Receiving a second ethics approval so soon after our first is exciting. We look forward to announcing further sites in Australia and USA.”
Involving non-small cell lung cancer patients
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.
The primary aim of the Phase-1 trial is to determine safety and an optimal biological dose as a monotherapy and later in combination with immune checkpoint inhibitors.
Efficacy, tolerability and immune response will also be measured.