Ann: Imugene Receives Third PD1-VAXX Ethics Trial Approval, page-2

ASX Announcement
IMUGENE RECEIVES THIRD ETHICS APPROVAL TO START PHASE I CLINICAL TRIAL OF NEW
CANCER IMMUNOTHERAPY PD1-VAXX IN AUSTRALIA
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• Cabrini hospital receives human research ethics approval for Phase I human trial of anti-cancer
immunotherapy PD1-Vaxx
• Ethics approval represents third independent review of PD1-Vaxx pre- clinical safety and efficacy
data
• Site activation complete and patient screening commenced at Macquarie University Hospital
SYDNEY, Australia, 21 August 2020: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology
company, today announced it has received a third 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 that Imugene has completed all the necessary pre-clinical safety
and efficacy testing of PD1-Vaxx required to commence human clinical trials.
The third hospital to receive ethics approval is the Cabrini hospital located in Melbourne
Australia. Additional clinical sites are being profiled in Australia, and also in the US following a
Food and Drug Administration (FDA) investigational new drug (IND) submission.
In further progress towards commencing clinical dosing, patient screening has now commenced 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.
Imugene MD & 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 third ethics approval and finalizing Macquarie University Hospital site activation process to
commence patient screening is exciting.”
2 IMUGENE LIMITED ACN 009 179 551
The Australian Lung Foundation estimates 12,800 Australians are diagnosed with lung cancer
each year.
Imugene’s PD1-Vaxx is a B-cell cancer immunotherapy designed to treat tumors 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 the other immune checkpoint inhibitor monoclonal antibodies
that are transforming treatment of a range of cancers.
Full study details can also be found on clinical trials.gov under study ID: NCT04432207.
For more information please contact:
Leslie Chong
Managing Director and Chief Executive Officer
T: +61 458 040 433
Follow us on Twitter @TeamImugene
Like us on Facebook @Imugene
Connect with us on LinkedIn @Imugene Limited
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a range of new and novel
immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate
tumors. Our unique platform technologies seek to harness the body’s immune system against tumours,
potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and
other immunotherapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates
and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard
of care drugs and emerging immunotherapies. We are supported by a leading team of international
cancer experts with extensive experience in developing new cancer therapies with many approved for
sale and marketing for global markets.
Our vision is to help transform and improve the treatment of cancer and the lives of the millions of
patients who need effective treatments. This vision is backed by a growing body of clinical evidence and
peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical
milestones. Together with leading specialists and medical professionals, we believe Imugene’s immunooncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene
and its shareholders are at the forefront of this rapidly growing global market.
Release authorised by the Managing Director and Chief Executive Officer