IMUGENE LIMITED — Regulatory Filings 2021

Apr 20, 2021

ASX Announcement

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Imugene Announces Clinical Trial Milestone for its HER-Vaxx Cancer Immunotherapy

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SYDNEY, Australia, 21 April 2021: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced a clinical milestone has been achieved for its HER-Vaxx cancer immunotherapy in the Phase 2 gastric cancer clinical trial.

Following completion of recruitment in January 2021, the important clinical endpoint of Progression Free Survival (PFS) has been met after the statistically significant required number of PFS events has occurred. Data from these 24 events will now be analysed with the final PFS readout expected within months.

Imugene’s MD & CEO, Mrs Leslie Chong said, “I am delighted to report that we have achieved this new significant milestone for patients with advanced gastric cancer, following on from the important interim data released in 2020 and new data presented at AACR earlier this month. I look forward to updating the market as the data is analysed.”

Imugene’s HER-Vaxx is a B-cell activating peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies, in Phase I and now Phase 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a wellknown and validated cancer target.

The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 36 patients with metastatic gastric cancer overexpressing the HER-2 protein. The study is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-ofcare chemotherapy alone. The primary endpoint is overall survival and secondary endpoint is progression-free survival. Safety, tolerability and immune response are also being measured.

The Phase 2 trial is being conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptin and

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Perjeta marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected.

Full study details can also be found on clinicaltrials.gov under study ID: NCT02795988

For further information please contact: Leslie Chong Managing Director and Chief Executive Officer T: +61 458 040 433 E: Leslie.Chong@Imugene.com

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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 immuno-oncology 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

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IMUGENE LIMITED ACN 009 179 551