Ann: Imugene Presents HER-Vaxx Update at ESMO World GI Congress, page-5

IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected]
ASX Announcement
Imugene Announces Presentation for Lead HER-2 Cancer Immunotherapy at the ESMO
World Congress on Gastrointestinal Cancer 2021 Annual Meeting
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SYDNEY, Australia, 5 July 2021: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology
company, today announced the company presented on the HER-Vaxx cancer immunotherapy program
at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting.
The abstract presentation was entitled ‘HERIZON: A PHASE 1B/2 OPEN-LABEL STUDY OF IMU-131
HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY WITH RANDOMIZATION IN
PHASE 2 IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED
ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION’ Updated Interim Analysis
Results.
The presentation expanded on previously presented interim analysis data presented at AACR2021.
To recap previously released results:
• Interim analysis in the randomized Phase 2 study showed statistically significant overall survival
Hazard Ratio (HR) of 0.418 (80% 2-sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of
death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemotherapy alone.
• The median overall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was 14.2
months, compared to 8.8 months in patients treated with chemotherapy alone.
• The Phase 2 data represent a clinical proof-of-concept signal for HER-Vaxx when added to
chemotherapy and indicate that B-cell activating immunotherapy vaccines can induce clinically
active antibody responses.
• Recruitment of the Phase 2 trial was completed in January 2021.
The ESMO presentation highlights and presents the following new data:
• HER-Vaxx treatment resulted in a 50% Overall Response Rate (ORR) compared to 29% in patients
treated with chemotherapy alone. The ORR measures the percentage of patients who responded
to treatment with a partial response (PR) or better.
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• Treatment with HER-Vaxx clearly demonstrates patients develop high levels of HER2-specific
antibodies early in the treatment protocol and are maintained during treatment and maintenance
phase with only a few booster injections.
• Tumour response is correlated with the amount of antibody levels. Patients with antibody levels
higher than 1050ng/ml received greater than 50% tumour reduction and may serve as a potential
biomarker.
• In contrast to patients on chemotherapy alone, the reduction of tumour size is substantially higher
in patients that received HER-Vaxx + chemotherapy.
Overall, this data demonstrates HER-Vaxx may provide treatment benefits consistent with traditional
monoclonal antibodies with a corresponding adaptive immune response without added toxicity.
Imugene’s HER-Vaxx is a B-cell activating cancer immunotherapy designed to treat tumours that overexpress 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 HER2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent
polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.
The content of the presentation can be found under Conference Presentations on the Imugene website.
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 such as CAR T’s for solid tumors. We are supported by a
3 IMUGENE LIMITED ACN 009 179 551
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
Imugene Limited, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia