Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) has received a third Human Research Ethics Committee (HREC) approval to begin a phase-1 human trial of anti-cancer immunotherapy candidate PD1-Vaxx in Australia.

Ethics approval is confirmation that Imugene has completed all the necessary pre-clinical safety and efficacy testing of PD1-Vaxx required to start human clinical trials.

The third hospital to receive ethics approval is the Cabrini hospital in Melbourne, Australia.

Additional sites are being profiled in Australia and the US following a Food and Drug Administration (FDA) investigational new drug (IND) submission.

“Significant milestone”

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.”

Shares have been as much as 11% higher this morning to A$0.062.

In further progress towards commencing clinical dosing, patient screening has started at Macquarie University Hospital, which has already received its ethics approval.

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.

Chong added: “Receiving a third ethics approval and finalising Macquarie University Hospital site activation process to begin patient screening is exciting.”

B-cell cancer immunotherapy

The Australian Lung Foundation estimates 12,800 Australians are diagnosed with lung cancer each year.

Imugene’s PD1-Vaxx is  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 similar to Keytruda®, Opdivo® and other immune checkpoint inhibitor monoclonal antibodies that are transforming treatment of a range of cancers.