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Imugene given all clear to start phase-1 clinical trial of new cancer immunotherapy PD-1 Vaxx in Australia

The ethics approval represents the second independent review of PD-1 Vaxx pre-clinical safety and efficacy.

Patient screening is scheduled to begin in August
Patient screening is scheduled to begin in August

Imugene Ltd (ASX:IMU) has received a second Human Research Ethics Committee approval to begin a phase-I clinical trial of its cancer checkpoint immunotherapy candidate, PD1-Vaxx in Australia.

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.

“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.

“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.

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Imugene gets green light to start phase-1 clinical trial of new cancer...

Imugene Ltd's (ASX:IMU) Leslie Chong speaks to Proactive's Andrew Scott following the news it's received a second Human Research Ethics Committee approval to begin a phase-I clinical trial of its cancer checkpoint immunotherapy candidate, PD1-Vaxx. Ethics approval is confirmation that Imugene...

on 20/7/20

2 min read