Imugene Limited’s (ASX:IMU) research has demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.
In empirical work, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Herceptin, which also targets the HER-2/neu oncogene.
It also demonstrated identical inhibition at one third dose compared with Herceptin.
While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.
“With improvements to the formulation of HER-Vaxx, and empirical-based optimism that HER-Vaxx appears superior to Herceptin, we are rapidly finalising plans to trial our novel HER-Vaxx immunotherapeutic vaccine in patients with gastric cancer later this year,” managing director Charles Walker said.
“We are developing HER-Vaxx to generate a fast and strong stimulation of patients’ immune systems to produce natural antibodies superior to Herceptin.”
The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.
Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems
Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.
HER-Vaxx Pre-Clinical Research
The research was conducted by a team at the Medical University of Vienna under the direction of Professor Dr Ursula Wiedermann.
Human breast cancer cell line SK-BR-3 overexpressing HER-2/neu was incubated with increasing concentrations of purified HER-Vaxx antibody or with Trastuzamab (Herceptin).
Her-Vaxx inhibited the proliferation of SK-BR-3 cells expressing high levels of HER-2/neu by 39% for 18.75ug dose, 58% for a 37.5ug dose and 66% for a 75ug dose.
This compared to a 39% inhibition by Trastuzamab at a 50ug dose.
The results indicate that Her-Vaxx is able inhibit the cancer cell growth with a dose of less than half that required for Herceptin while the higher dose is able to generate a response 70% greater.
Enhanced Formulation
In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.
Manufacturing has also been simplified with increased reliability and lower cost.
Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.
Upcoming Clinical Trial
The upcoming Phase 1b/2 trial is designed to yield as much data and information as possible to guide the company and potential partners to develop HER-Vaxx into a commercial pharmaceutical as quickly and as efficiently as possible.
Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.
Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.
Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.
This study will be a key inflection point underpinned by many years of research.
Once the study begins, the company will increase business development work and meet with prospective partners to inform them of our progress, our innovative technology and trial design.
With the depreciation in the Australian dollar and incentives in Australia, Imugene plans to conduct the trial in as many Australian hospitals as possible without compromising speed or efficiency.
This will be better value for money, trial management will be more efficient and will likely benefit Australian trial participants with gastric cancer.
Analysis
The empirical data demonstrating that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin is promising.
Shares in the company should trade higher on the news.
It also ensures the upcoming Phase 1b/2 clinical trial, which could provide a clinical demonstration of this efficacy, will be closely watched.
Success will allow Imugene to provide a superior alternative to Herceptin, which is a US$6 billion to US$7 billion per annum global market, providing significant upside.
HER-Vaxx also has lower production costs and potentially an opportunity for a single vaccination unlike Herceptin, which requires a more expansive treatment cycle.
Share Price Catalysts
- Appoint CRO to run trial 1H 2015;
- US FDA IND granted 1H 2015;
- Appoint Principal Investigator 1H 2015;
- Announce preclinical toxicology results 1H 2015;
- Recruit and run lead in Phase 1b trial 2H 2015;
- Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
- Report Phase 1 trial results 2H 2015 to 1H 2016; and
- Report Phase 2 results 2H 2017/1H 2018.
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