(MENAFN- ProactiveInvestors) Australian immuno-oncology company Imugene () has met two more milestones as it prepares to initiate the clinical program for its Her-Vaxx peptide vaccine in 2015.
The company has substantially finalised the clinical protocol for the Phase Ib/II clinical trial in patients with gastric cancer.
It has also appointed respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies to support the clinical trial planned by the company.
Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.
It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.
Imugene chief executive officer Charles Walker said the milestones emphasised the company’s focus to conduct an efficient high quality Phase II trial that pharmaceutical companies prefer to see.
“The next step is to appoint an internationally regarded CRO in 1H 2015 to efficiently manage the clinical trial. The trial remains on track to start in the second half of next year.”
The company has raised over $3.5 million through two recent placements and a share purchase plan to fund development of Her-Vaxx.
WIL Research is a global CRO that provides a range of premium discovery support services product safety toxicological research analytical chemistry and formulation services.
It has over 1200 employees across world-class facilities in the US Netherlands France and Japan.
HER-Vaxx
HER-Vaxx is a proprietary peptide vaccine or immunotherapy that causes the immune system to generate cancer-fighting antibodies..
It achieves this by stimulating a polyclonal antibody response to HER-2/neu the same biomarker targeted by the $US6.4 billion per annum drug Herceptin.
HER-Vaxx has successfully completed a Phase I study in patients with breast cancer confirming that it produced negligible toxicity and was tolerated by patients with no side effects.
Patients developed anti-HER-2 antibodies and these antibodies displayed potent anti-tumour activity showing immune response.
The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety evaluate optimal dosing and to show efficacy.
This is expected to start in the second half of 2015 following the appointment of a CRO to manage the trial.
Phase Ib will be an open label Trial in which both the researchers and participants know which treatment is being administered. This will include 18 patients divided into 3 groups of 6.
The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study evaluate toxicity measure immunogenicity (immune response) and test a booster schedule that compares 4 weeks of treatment to 8 weeks.
The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe and be a blinded placebo controlled trial that evaluates efficacy safety and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy and 34 patients treated only with chemotherapy.
The endpoints of the trial will establish an overall survival rate and progression to survival. The secondary endpoint will measure immune response.
This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.
Gastric cancer global overview
Gastric cancer is the second leading cause of cancer mortality and the fourth most common cancer in the world. Approximately 934000 new cases of gastric cancer are diagnosed each year which produces approximately 700000 deaths that account for 10.4% of cancer deaths worldwide each year.
The European Union (27 states) estimated around 83000 new cases of stomach cancer were diagnosed and recorded 55896 deaths in the latest reporting year.
In 2012 the U.S. estimated 21300 new cases and 10540 deaths from stomach cancer.
Australian authorities estimate that there are about 1900 new cases each year and China has the largest patient population that makes up 42% of worldwide cases.
The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.
Multiple share price catalysts for near term valuation increase
- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018
Analysis
Imugene has achieved two milestones as it continues preparations to initiate the clinical program for its Her-Vaxx peptide vaccine in the second half of 2015
The finalisation of the clinical protocol for the Phase Ib/II clinical trial and appointment of WIL Research to conduct important FDA IND enabling preclinical studies are both key steps towards conducting an efficient high quality Phase II trial that will draw attention from pharmaceutical companies.
With significant news flow and price catalysts milestones in the development of HER-Vaxx one of the world’s most advanced B-cell vaccines in sight there is potential for the current valuation to lift in 2014/15.
Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.
Proactive Investors has estimated a 6-12 month share price target of $0.034 - $0.047.
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