Imugene (ASX:IMU) has hit a milestone with global contract research organisation (CRO) Simbec-Orion selected to conduct the upcoming HER-Vaxx gastric cancer human clinical trial.
The Phase 1b/2 clinical study is on track to begin in the second half of 2015.
Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.
It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.
In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.
It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.
Charles Walker, managing director, said:
“This is another milestone passed as the selection of specialist CRO Orion will greatly assist the company conduct a thorough and well prepared immuno-oncology clinical trial.
“Our trial is designed to be statistically robust and also yield early significant data. The trial has been designed to appeal to potential partners and help steer the Phase 3 clinical trial design.
“We look forward to working with our new partner and reporting on the inevitable progress.”
Ronald Openshaw, Simbec-Orion chief executive officer, added:
“We are pleased to prevail in Imugene’s stringent selection process and look forward to driving this important clinical trial.
“We will ensure a combination of rigour and efficiency and are adamant about achieving on timelines and quality of data that should satisfy the US FDA.”
HER-Vaxx
HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.
HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.
HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.
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.
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.
Analysis
The appointment of global CRO Simbec-Orion to fast track plans and logistics for the upcoming HER-Vaxx gastric cancer human clinical trial is a key milestone for Imugene.
The upcoming Phase 1b/2 clinical study in the second half of 2015 is expected to be closely watched given the encouraging pre-clinical data.
Share Price Catalysts
- Grant of US FDA IND;
- Appoint Principal Investigator;
- Announce preclinical toxicology results;
- 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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