Minomic: Agreement To Begin First-In-Human Trial Of Novel Prostate Cancer Imaging Agent

.. Heads of Agreement signed with Macquarie University Hospital and Macquarie Medical Imaging

.. Study to examine company’s proprietary antibody MIL-38 as an imaging agent

.. 12 Australian cancer patients to be involved in trial

.. Trial to commence Q12016

SYDNEY--(BUSINESS WIRE)--Australian immuno-oncology company Minomic International Ltd has struck an important agreement to launch the first human study of its novel monoclonal antibody technology as an imaging agent to detect prostate, pancreatic and bladder cancers.

“Macquarie University is committed to bringing cutting-edge medicine to patients and we see this trial as the first step to delivering proof-of-concept treatments to patients with life threatening diseases.”

The company has signed a Heads of Agreement with Macquarie University Hospital (MUH) and Macquarie Medical Imaging (MMI) to examine the use of Minomic’s proprietary MIL-38 monoclonal antibody (already a centrepiece of its novel prostate cancer diagnostic screening technology) as a new tool to enable better detection and targeted treatment of prostate and other cancers.

This first-in-human study will begin recruiting the first of 12 patients in Q1 2016, with the study expected to run during 2016.

Under study protocols, a team of investigators led by Professors Howard Gurney and David Gillatt from MUH and Dr Kevin Ho-Shon of MMI, will examine a chimeric version of Minomic’s MIL-38 antibody conjugated with ⁶⁷Gallium (MILGa) to image cancer metastases following ethics approval.

Investigators will evaluate the technology for safety, sensitivity and specificity of MILGa in these patients.

Professor David Gillatt said: “Macquarie University is committed to bringing cutting-edge medicine to patients and we see this trial as the first step to delivering proof-of-concept treatments to patients with life threatening diseases.”

Minomic Chief Executive Officer Dr Brad Walsh said signing the agreement was a key milestone for the company as it prepared to further exploit the potential of its antibody technology.

“We have been focused to date on commercialising our lead prostate cancer diagnostic technology known as MiCheck®, but have consistently acknowledged the potential for our antibody to be used for imaging and therapeutic purposes,” he said.

“We have had highly encouraging results in our preclinical animal studies. By formulating a chimeric version of the MIL-38 antibody, we are able to ensure a patient’s own immune system does not recognise our antibody as foreign. Our antibody will then seek out the target, which is a protein found on cancer cells. We will attach a payload to our antibody – either an existing drug or radiotherapy – so that our technology can be used to directly deliver the appropriate therapy to the tumour cell target for maximum impact. Following successful targeting to tumour metastases in this study the company intends to undertake a therapeutic trial.”

To view a recent investor presentation by Minomic CEO Dr Brad Walsh, please click on this link: https://vimeo.com/142577816.

About Minomic

Minomic International Ltd is an Australian immuno-oncology company specialising in therapeutics and diagnostics for prostate cancer and other cancers. Minomic has developed the in vitro diagnostic test called MiCheck® for the early detection of prostate cancer. Minomic is preparing to globally launch its first product, a novel prostate cancer blood test known as MiCheck®, which has been shown to be more than twice as specific as the existing gold standard Prostate Specific Antigen (PSA) screening technology. The simple MiCheck® technology uses Glypican-1, a newly identified biomarker. Minomic scientists have also identified two other biomarkers never previously used in prostate cancer diagnosis to further improve the test.

Following a successful 300 patient clinical study demonstrating good specificity of 85% for discriminating prostate cancer patients from those with benign prostatic disease, the test is about to enter final stage validation trials. This means that MiCheck® delivers only 1.5 false positives from every ten samples, compared to 6 false positive results in every 10 samples using the standard PSA test.

Minomic is interested in partnerships or collaborations with larger pharmaceutical/diagnostic global partners able to produce, register and distribute the MiCheck® test and collaborate through registration and commercialisation of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate and other cancers.