Imugene (ASX:IMU) is preparing to initiate this year the clinical program for its Her-Vaxx peptide vaccine, a B-cell based immunotherapy for HER-2 positive gastric & breast cancer.
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.
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HER-Vaxx is a proprietary peptide vaccine developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.
It causes the immune system to generate cancer-fighting antibodies by stimulating a polyclonal antibody response to biomarker HER-2/neu.
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.
Recently, Imugene achieved two milestones, substantially finalising the clinical protocol for the Phase Ib/II clinical trial and appointing respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies.
Multiple 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
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