Cleanroom facility revealed by Cartherics for the production of cell therapy treatments
Cartherics Unveils New Cleanroom Facility for Cell Therapy Production
Cartherics, an Australian biotech company, has recently unveiled a state-of-the-art cleanroom facility in Melbourne, Australia. This new facility is designed for clinical-scale manufacturing of cell therapy products, including the company's lead product, CTH-401, which is currently in advanced preparation stages for clinical trials targeting relapsed and refractory ovarian cancer.
The official opening of the new facility was conducted by the Hon Ed Husic MP. Prof. Alan Trounson AO, CEO of Cartherics, stated that the completion of the cleanrooms allows for clinical manufacturing to begin for Cartherics' therapeutic products targeting ovarian cancer and endometriosis.
The new facility is situated in the Ferntree Gully Precinct of Notting Hill, Victoria, and is equipped with comprehensive environmental control systems and advanced manufacturing technologies. This investment strengthens Melbourne's position as a leader in advanced medical manufacturing and translational research.
CTH-401 is a CAR-NK cell therapy derived from induced pluripotent stem cells (iPSCs). This approach uses gene-edited natural killer cells designed to overcome immune suppression in the tumor microenvironment, a significant challenge in solid tumor cancers like ovarian cancer. The therapy aims to provide an off-the-shelf, scalable solution with enhanced capability to target and eliminate ovarian cancer cells, especially in patients whose cancer has relapsed or is refractory to previous treatments.
Cartherics is working towards submitting an IND for CTH-401 to the US FDA in mid-2026. Once approved, clinical trial initiation is expected to follow shortly. The first clinical indication for CTH-401 will be relapsed and refractory ovarian cancer.
Future plans include expanding the cell therapy pipeline to include additional engineered immune cell types such as iT cells and imacrophages. Cartherics is also committed to continued innovation in manufacturing technologies to enable large-scale, consistent production of CAR-NK cell therapies at the new cleanroom facility.
The new facility is a significant investment by Cartherics, showcasing its dedication to being a key player in Victoria's thriving biotech sector. The company's ambition is to advance toward clinical testing of CTH-401 to offer a novel immunotherapy option for difficult-to-treat ovarian cancer, with aspirations to expand into other women’s health indications and solid tumor cancers.
- The new cleanroom facility by Cartherics in Melbourne is not only for manufacturing their lead product, CTH-401, which is targeting relapsed and refractory ovarian cancer, but also for future developments in women's health, such as treating endometriosis.
- Aside from its initial focus on ovarian cancer, Cartherics plans to expand the cell therapy pipeline to include engineered immune cell types like iT cells and imacrophages, with the ultimate goal of exploring these therapies for other medical-conditions like solid tumor cancers, contributing to the advancement of health-and-wellness for all.
