SYDNEY--(BUSINESS WIRE)--Australian immuno-oncology company Minomic International Ltd is proceeding to the second stage of its pioneering MILGa clinical trial of MiltuximabTM, a chimeric version of Minomic’s MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope 67Gallium.
The MILGa Cancer Imaging Trial is a first-in-human study to evaluate the safety and tumor targeting of MiltuximabTM in patients with metastatic prostate, bladder, and pancreatic cancer. The primary endpoint of the MILGa trial is safety and tolerability of the MiltuximabTM drug. Secondary endpoints include tumor targeting, pharmacokinetics and dosimetry to determine relative accumulation of MILGa in different organs.
Following a pre-specified interim analysis of safety data from the first six patients, the trial’s independent Drug Safety Monitoring Committee has formally approved the continuation of the clinical trial to the final six of twelve subjects.
The first half of the study dosed two patients with pancreatic cancer and four with prostate cancer. MILGa was well tolerated and no drug related adverse events were reported.
The Minomic Drug Safety Monitoring Committee is drawn from radiopharmaceutical and oncology groups at two major public hospitals in Sydney, Australia. The Committee comprises Dr Vijay Kumar, Head of Radiopharmaceutical Research at Westmead Hospital, and Dr Matteo Carlino and Dr Bo Gao, who are both Staff Specialists Medical Oncology at Blacktown and Westmead Hospitals.
Preclinical studies have demonstrated that MILGa accurately targets prostate, pancreatic, and bladder cancer cells, and is well-tolerated and highly specific in mouse models of prostate cancer.
Minomic’s Chief Executive Officer, Dr Brad Walsh, said, “The results from this trial are providing us with important safety data as well as telling us how well the antibody targets different tumour types. We will use this information to guide the future development of the drug.”
“Passing this key formal stage in our trial is very encouraging,” he added. “There are no approved antibody therapies for prostate or pancreatic cancer, whilst bladder cancer remains extremely expensive to treat. There is therefore the potential for major advances in the treatment of these cancers.”
MiltuximabTM is an IgG1 murine monoclonal antibody (mAb) directed against Glypican-1 (GPC-1), with demonstrated strong reactivity to prostate, bladder and pancreatic cancer cell lines. GPC-1 is also overexpressed in other cancer types, such as oesophageal cancers and glioblastoma.
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.