Anti-GPC-1 Antibody for Therapeutic & Imaging Applications
Our patented antibodies target Glypican-1 (GPC-1), a protein overexpressed in prostate, pancreatic, bladder, glioblastoma, esophageal, lung and ovarian cancers. Importantly, there is no antibody reactivity in normal tissues.
We have now completed a First-in-Human trial in Australia using Miltuximab®, our anti-GPC-1 monoclonal antibody (ANZCTR registry). The trial dosed 12 patients and no drug-related adverse events were observed.
We are currently raising funds to run a Phase-1b theranostic study of at least 12 more patients. Candidates will be selected by PET imaging using 89Zr-Miltuximab® and then dosed with 177Lu-Miltuximab® , the therapeutic version.
Glytuzumab® refers to the humanized version of Miltuximab® and also targets human GPC-1. The Glytuzumab® program is currently undergoing Lead Optimization and Lead Selection. Several humanized leads have been generated with similar binding affinities to that of the parent molecule Miltuximab®. The final Glytuzumab® lead selected will be taken forward from cell line development through to large scale GMP production for future clinical trials.
Achievements
2022
High-Yield GMP-Compliant Primary Cell Bank Established for Miltuximab®
GlyTherix and GEMINI Collaborate on Esophageal Cancer
2021
Commenced production of GMP-Miltuximab® for Phase-1b clinical trial
2020
Carina Biotech and GlyTherix enter into CAR-T partnership
GlyTherix’s Miltuximab® antibody becomes the flagship project for a Co-operative Research Centre Project Grant
2019
Preclinical work now completed for upcoming Phase I clinical trial in GPC-1 expressing solid tumours. This will use Miltuximab® labelled with either 89Zirconium for imaging or 177Lutetium for therapy
First-in-Human clinical trial of Miltuximab® labelled with 67Gallium for imaging met primary endpoint of safety in all 12 patients
Antibody composition of matter patents granted EU and US