SYDNEY--(BUSINESS WIRE)--Minomic International Ltd (Minomic) is an immuno-oncology company specializing in therapeutics and diagnostics for solid tumors, including prostate, bladder and pancreas. The Company today announced that it has completed enrollment and dosing of the first three patients in its pioneering clinical trial of MILGa, 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 MILGa in patients with advanced prostate, bladder and pancreatic cancer. The primary endpoints of the study are safety and tolerability of MILGa. The secondary endpoints are to qualitatively evaluate the MILGa as a diagnostic tool in prostate, bladder and pancreatic tumors, and also to perform dosimetry analysis of tumor images to determine relative accumulation of MILGa in different organs. 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.
Three patients, 2 with pancreatic and 1 with prostate cancer, have been dosed so far and have completed 1 month follow-up that MILGa was well tolerated and patients reported no drug related adverse events. The study plans to enroll 12 patients in total to confirm accurate tumor targeting in patients that have between 2 and 15 metastases.
Minomic’s CEO, Dr Brad Walsh, said, “The results from this trial will provide 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. The initial findings for the first three patients are 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”
MIL-38 is an IgG1 murine monoclonal antibody (mAb) derived from the parental BLCA-38 antibody directed against Glypican-1 (GPC-1), with demonstrated strong reactivity to prostate, bladder and pancreatic cancer cell lines. The parental BLCA-38 antibody demonstrates cell-killing activity in bladder and prostate cancer xenograft models when labeled with 153Samarium or 213Bismuth radioisotopes.
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 the in vitro diagnostic test called MiCheck® test for the early detection of prostate cancer. Minomic is preparing to globally launch 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 newly 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 commercialisation of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.