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Imugene rings in changes as gastric cancer trial preparation picks up pace

Tuesday, January 05, 2016

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Imugene (ASX:IMU) has added Dr. Anton Uvarov to its Board as a non executive director as the immuno-oncology company picks up the pace of work for its gastric cancer study in 2016.

Dr Uvarov worked for two years in the U.S. healthcare research team at Citigroup Global Markets covering small and mid-cap biotechnology companies and holds a PhD degree in Biochemistry and Medical Genetics.

Stuart Roberts was appointed Head of Corporate Development this week. Previously he worked at Prima BioMed (ASXRR).

Imugene is a clinical stage immuno-oncology company with a lead product, HER-Vaxx a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene's unique immunotherapy has been shown in pre-clinical work and in one Phase 1 study to stimulate a potent polyclonal antibody response to HER-2/neu, a known and validated cancer target.

HER-Vaxx’s successful Phase 1 study was in patients with breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer.

Novotech was recently appointed as the lead contract researcher for the upcoming Phase 1b/2 trial of HER-Vaxx in gastric cancer.

The trial design was largely completed with a focus on Asia. Start up activity for the HER-Vaxx Phase 1b/2 study in gastric cancer is underway and clinical commencement is expected in the first half of 2016.

Under Novotech, Imugene’s investigators will recruit patients with HER-2 positive gastric cancer at a number of leading cancer centres in Asia.

The study will be conducted in two parts. The initial Phase 1b will be an open-label dose escalation study designed to evaluate the safety as well as the pharmacokinetics of HER-Vaxx. This will also determine optimal dosage.

A larger Phase 2 study will be a randomised controlled study of HER-Vaxx plus standard of care against standard of care alone.