SYDNEY, Australia, 1 October 2019: Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced comprehensive clinical data results from the Phase Ib clinical study of its HER-Vaxx anti-cancer vaccine were presented at the European Society of Medical Oncology in Barcelona, Spain held from 27 September to 1 October 2019.
The data, presented in a poster, described further comprehensive analysis of results from Imugene’s Phase Ib HER-Vaxx study in gastric cancer patients over-expressing the HER2 target protein. It was presented by the lead-inventor of the vaccine Professor Dr. Ursula Wiedermann from the Medical University Vienna, Austria.
The data showed a 100 per cent objective response rate in three patients who received the optimal dose of 50 micrograms. The FDA definition of objective response rate is the ‘proportion of patients with tumour size reduction of a predefined amount and for a minimum time period’.
In five of 11 patients evaluable for tumour responses, tumour reduction was associated with high HER2-specific antibody levels which showed a capacity to inhibit HER2-phosphorylation. Inhibition of HER2- phosphorylation is a key mechanism of successful HER2-targeting drugs which inhibit cancer cell growth.
An open label Phase II study of HER-Vaxx in 68 patients with metastatic gastric cancer over-expressing the HER-2 protein was initiated in March 2019 and the company aims to complete the study in 2020.
Imugene Managing Director and Chief Executive Officer Leslie Chong said, “We are pleased to share this promising new clinical data with the international medical community at ESMO. Together with our dedicated investigators and research teams we are building an impressive library of evidence to support the clinical potential our unique B-cell cancer vaccine pipeline and clinical development strategy.”
Imugene’s HER-Vaxx is a B-cell peptide cancer vaccine 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 and now in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.
The poster (abstract number 1212P) is entitled ‘Comprehensive results of a Phase Ib study with a HER2/neu B-cell peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy show safety, immunogenicity and clinical response in patients with HER2/neu overexpressing advanced gastric cancer’.
The poster presentation is available on the Imugene website https://www.imugene.com/publications.
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 tumours. 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.
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Ashley TappAssociate Partner