Cell therapy immuno-oncology company Carina Biotech has appointed Australian organisation Cell Therapies to undertake Good Manufacturing Processes manufacture of its LGR5 CAR-T cells for a first-in-human clinical trial.
CEO Dr Deborah Rathjen said, “We are delighted to be working with Cell Therapies, with their deep expertise in cell therapy development and manufacturing. Also, it’s fantastic to be working with another Australian-based organisation. This will allow our teams to work efficiently together during the development phase and through the manufacturing process.”
Cell Therapies CEO Peter Giannopoulos said, “As the first Australian site to obtain TGA approval to commence onshore manufacture of CAR-T cell therapy products, we are delighted to now be working with an Australian company that is advancing a promising CAR-T cell therapy candidate in colorectal cancer.”
Dr Rathjen continued, “Colorectal cancer is Australia’s second deadliest cancer and its incidence is rising in people under the age of 50 – with many of these people being diagnosed at advanced stages of the disease and with a very poor prognosis.
"Our LGR5 CAR-T cell has continued to deliver impressive results in pre-clinical testing. We submitted our pre-IND application in March this year and we are on track to file an IND application with the FDA in the second half of 2022. These are important milestones towards the initiation of a Phase I/II clinical trial in patients with advanced colorectal cancer.”