ASX AnnouncementImugene Announces Clinical Trial Milestone for...

ASX Announcement

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
2 IMUGENE LIMITED ACN 009 179 551

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: [email protected]
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