Imugene Limited (ASX:IMU) has received Human Research Ethics Committee (HREC) approval to commence a phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx in Australia.
PD1-Vaxx is a B-cell cancer immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction and produce an anti-cancer effect.
The first-in-human, phase 1, multi-centre, dose-escalation study of PD1-Vaxx will involve patients with non-small cell lung cancer.
Primary objectives are safety and optimal dosage
Medical investigators will test different doses of PD1-Vaxx as a monotherapy and in combination with immune checkpoint inhibitor drugs.
The primary objective of the phase 1 trial is to determine safety and an optimal biological dose as monotherapy and in combination with immune checkpoint inhibitors.
Efficacy, tolerability and immune response will also be measured.
“Paradigm shift in oncology”
Imugene managing director and chief executive officer 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.
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential.
“The concept of teaching and inducing the body to generate its own antibodies targeting PD1 expressing cells represents a paradigm shift in oncology, and is a novel treatment method for cancer.”
Pre-clinical safety and efficacy testing completed
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 Australian Lung Foundation estimates 12,800 Australians are diagnosed with lung cancer each year.