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Imugene Announces First Patient Dosed in the Open-Label Phase 2 Study with HER-Vaxx Cancer Vaccine for Advanced Gastric Cancer

Imugene Announces First Patient Dosed in the Open-Label Phase 2 Study with HER-Vaxx Cancer Vaccine for Advanced Gastric Cancer

  • First patient dosed in 68 patient Randomised Phase 2 HER-Vaxx cancer trial
  • Two Eastern European sites now actively recruiting
  • Approval imminent for trial sites in Hong Kong, Taiwan, Thailand and India

SYDNEY, Australia –14 March 2019 – Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced dosing of the first patient in an open-label, randomised multi-centre Phase 2 study with its HER-Vaxx (IMU-131) cancer vaccine for the treatment of HER-2 positive gastric cancer patients.

The first patient in the study was dosed at the Oncological Institute in Chisinau, the capital of Moldova, in Eastern Europe.

HER-Vaxx is a potentially groundbreaking cancer vaccine designed to produce an antibody response against a cancer growth signal receptor protein called HER-2 which is found on the cell surface of multiple cancers including breast and gastic cancers.

Imugene Managing Director and Chief Executive Officer Leslie Chong said, “There is strong medical investigator interest following the good results seen in the recently completed Phase 1b trial, where 11 out of 14 evaluable patients showed clinically meaningful responses. We look forward to providing regular recruitment updates as the Phase 2 study moves toward completion in 2020.” 

“The start of the Phase 2 study is an important milestone for Imugene and the many medical professionals seeking treatments for patients with advanced HER-2 positive gastric cancer who often have very few medical options.”

The Phase 1b HER-Vaxx study reported no safety or toxicity issues. All evaluable patients showed increased antibody responses. One patient saw a complete response, five had a partial response and four recorded a stabilisation of their disease.

The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 68 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-of-care alone. The primary endpoint is overall survival and secondary endpoint will be progression-free survival. Safety, tolerability and immune response will also be measured.

The Phase 2 trial is being conducted at multiple sites across Asia, Eastern Europe and India where patients have difficulty accessing approved antibody treatments such as Herceptin and 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 clinical under study ID: NCT02795988

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 technology seeks to harness the body’s immune system to generate antibodies against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody therapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates 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 a foundation treatment for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

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