June 27, 2017: [Sydney] 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 tumor 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.”

About MIL-38

MiltuximabTM is a chimeric 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.