Cashed up Imugene to present at American Association for Cancer Research

By Meagan Evans. Published at Feb 28, 2019, in Biotech

Clinical stage immuno-oncology company, Imugene Limited (ASX:IMU), is developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors.

Its 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.

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.

Imugene’s Phase 1b/2 clinical trial is targeting patients with HER-2 positive gastric cancer. The group selected HER-2 positive gastric cancer as this type is not nearly as well served as breast cancer, yet still has approximately the same number of patients being HER-2 positive and is more severe than breast cancer, offering a significant market opportunity for HER-Vaxx.

The Phase 1b stage of the Phase 1b/2 trial has completed with all endpoints being met. Phase 1b established safety, tolerability and the dose for the Phase 2 portion of the trial.

The Phase 2 stage of the HER-Vaxx trial in HER-2 positive gastric cancer commenced in February 2019.

The company today provided a half year review of its financial results to December 31, 2018.

The group reported a loss for the half-year ended 31 December 2018 of $3,449,097. This was up from $1,632,852 a year earlier largely due to the significant increase in clinical trial and research activities undertaken by the group.

On the back of a successful $20.1 million capital raise (before costs) in July 2018, the group's net assets increased to $31,189,570 compared with $15,475,479 at 30 June 2018. As at 31 December 2018, the group had cash reserves of $24,053,140, up from $7,822,057 at (30 June 2018).

The focus of the group’s operations in the short- to medium-term will be directed at the Phase 1b/2 gastric cancer study design, as follows:

  • HER-Vaxx: recruitment of phase 2 trial with gastric cancer patients,
  • KEY-Vaxx: accelerate pre-clinical studies; obtain an IND ‘go’ and to commence the clinical trial.

The company also announced that Professor Ursula Wiedermann will present on the HER-Vaxx cancer vaccine at the American Association for Cancer Research (AACR) 2019 Annual Meeting scheduled for March 29 to April 3, 2019.

The poster will be presented by Prof. Wiedermann, the co-inventor of the HER-Vaxx cancer vaccine and member of the IMU’s Scientific Advisory Board.

The abstract presentation is titled ‘A Phase Ib open label multicenter study with a HER2/neu peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy shows safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced cancer of the stomach.’

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 in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

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