Market Overview

Minomic Completes Prospective Clinical Study Using MiCheck® to Assist in Diagnosis of Prostate Cancer

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  • 58% Fewer patients proceed to Biopsy
  • US Rollout well advanced

Australian immuno-oncology company Minomic International Ltd is pleased
to announce the completion of its prospective clinical trial of the
company's novel prostate cancer diagnostic test, MiCheck®.
The trial demonstrated utility identifying patients with elevated PSA
who did not require a biopsy. The prospective trial demonstrated that
using MiCheck® could reduce the number of patients (with a
clinically elevated PSA) proceeding to biopsy by up to 58%.

The trial was a prospective, non-randomized case-control study, with a
primary endpoint of detecting prostate cancer vs no cancer and a
secondary endpoint, differentiating between aggressive and
non-aggressive cancer. Twelve US research centers located across the US,
all part of the CUSP Uro-Oncology Network, provided samples from 384
patients.

Both endpoints were met, demonstrating competitive sensitivity and
specificity in both the identification of prostate cancer and
differentiating aggressive from non-aggressive cancer.

Minomic's CEO, Dr. Brad Walsh, noted "We are very pleased with these
results. MiCheck® has continued to show significant utility
in assisting clinicians to decide whether patients require biopsy. This
has major health economic benefits, reducing the need for biopsy, a
costly and invasive procedure, as well as obvious patient benefits."

The results from the trial also provide a strong foundation for the US
rollout of MiCheck® as a Laboratory Developed Test (LDT).
Minomic is well advanced in discussions with a number of potential
laboratory partners with a view to making the test available as soon as
possible.

Dr. Neal Shore, Director of Carolina Urologic Research Center, who is
the trial's Principal Investigator, commented "New biomarker tests such
as MiCheck® will assist clinicians in selecting and
optimizing a more precise clinical pathway for both the diagnosis and
treatment of prostate cancer."

About Minomic

Minomic International Ltd is an Australian immuno-oncology company
specialising in therapeutics and diagnostics for solid tumors, including
prostate, bladder and pancreas. Minomic has developed an in vitro
diagnostic test called the MiCheck® test for the detection of
prostate cancer. Minomic is preparing to globally launch the MiCheck®
test, which has been shown to be more than twice as specific as the
existing gold standard Prostate Specific Antigen (PSA) screening
technology. 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. The MiCheck®
technology uses Glypican-1, a recently identified biomarker and other
biomarkers never previously used in prostate cancer diagnosis. 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 commercialization of future diagnostic imaging and
therapeutic applications of the MIL-38 antibody for prostate cancer.

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