Imugene Limited, a clinical stage immuno-oncology company, announced new clinical data from the Phase Ib study of its HER-Vaxx cancer vaccine showing cancer fighting antibody and clinical response rates continue to be positive in the patients receiving the optimal biological dose of vaccine.
SYDNEY, Australia – 8 July 2019 – Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, today announced new clinical data from the Phase Ib study of its HER-Vaxx cancer vaccine showing cancer fighting antibody and clinical response rates continue to be positive in the patients receiving the optimal biological dose of vaccine.
Patients have maintained strong and high levels of HER-2 targeting antibodies indicating a durable response is present with no resistence developed. Of the three patients receiving the optimal biological dose, and selected Phase 2 dose, one patient has seen a total tumour reduction of almost 80% from baseline CT scan with one out of four of their lesions becoming unmeasurable by RESIST criteria at Day 266 visit.
Imugene Managing Director and Chief Executive Officer Leslie Chong said, “This latest presentation from the HER-Vaxx Phase 1b study further reinforces the very good early results and ongoing interest among the international oncology community in our potentionally promising B-cell platform cancer vaccine and clinical development strategy.”
The positive new data was presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona Spain over the weekend. The data will be published in the prestigious Annals of Oncology after the congress.
The oral presentation (reference SO-004) gave an update on the progress of patients in the Phase 1b study and was delivered by Dr Marina Maglakelidze from the Research Institute of Clinical Medicine in Tbilisi, Georgia to international delegates.
The Phase 1b HER-Vaxx study in metastatic gastric cancer patients overexpressing the HER-2 protein completed enrolment in late 2018 and reported no safety or toxicity issues. All evaluable patients showed increased antibody responses. The Phase 2 study began enroment in March 2019 and is scheduled to complete in 2020.
The presentation by Dr Maglakelidze is titled: ‘A phase 1b study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction.’
ESMO’s World Congress on Gastrointestinal Cancer is focused on the practical needs of clinicians seeking to enhance their knowledge and management of cancers of gastrointestinal tract.
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 full presentation is available on the Imugene website publications page. The video of the presentation will be uploaded shortly.
Notes To Editors
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.
Follow us on Twitter @TeamImugene
Like us on Facebook @Imugene
Connect with us on LinkedIn @Imugene Limited
Issued for and on behalf of Imugene by Instinctif Partners.
For more information please contact:
Imugene
Leslie Chong, Managing Director and Chief Executive Officer
T: +61 458 040 433
E: Leslie.Chong@Imugene.com
City Public Relations (Australia Media enquiries):
Andrew Geddes
T: +61 (02) 9267 4511
E: ageddes@citypublicrelations.
Instinctif Partners (International Media enquiries):
Sue Charles / Genevieve Wilson
T: +44 (0)20 7457 2859
E: imugene@instinctif.com
