Australian immuno-oncology company Minomic has announced it is proceeding to the second stage of its MILGa clinical trial of Miltuximab, a chimeric version of Minomic’s MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope Gallium.
The MILGa Cancer Imaging Trial is a first-in-human study to evaluate the safety and tumour targeting of Miltuximab in patients with metastatic prostate, bladder, and pancreatic cancer. The primary endpoint of the MILGa trial is safety and tolerability of the Miltuximab drug. Secondary endpoints include tumour 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, said the company.
The Minomic Drug Safety Monitoring Committee is drawn from radiopharmaceutical and oncology groups at two major public hospitals in Sydney. The committee is comprised of Dr Vijay Kumar, head of Radiopharmaceutical Research at Westmead Hospital, and Dr Matteo Carlino and Dr Bo Gao, who are both staff specialists in 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," said the company in a statement.
According to CEO, Dr Brad Walsh, “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.
“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,” he added.