Melbourne-based biotechnology company Cartherics has officially opened a new state-of-the-art cleanroom facility in Notting Hill, Victoria, designed to support clinical-scale manufacturing of its cell therapy products. The facility was opened by Federal Member for Chifley, the Hon Ed Husic MP, during a launch event attended by key stakeholders and industry partners.
The new manufacturing facility represents a critical milestone for Cartherics, which is developing off-the-shelf immune stem cell therapies focused on high-impact women's diseases. The company's primary focus areas include ovarian cancer and endometriosis, with additional programs targeting triple-negative breast cancer and other conditions with unmet clinical needs.
CTH-401 Clinical Manufacturing Capabilities
Once validated, the facility will enable the manufacture of clinical batches of Cartherics' lead cell therapy candidate, CTH-401. This CAR-iNK cell product carries a chimeric antigen receptor (CAR) directed against TAG-72, a well-validated tumor target, along with the deletion of two genes associated with immunosuppression.
The first clinical indication for CTH-401 will be relapsed and refractory ovarian cancer. Cartherics anticipates submitting an investigational new drug (IND) application to the US Food and Drug Administration by mid-2026, marking a significant step toward clinical trials.
"The completion of the cleanrooms means that clinical manufacturing can now begin for Cartherics' therapeutic products targeting ovarian cancer and endometriosis," said Cartherics CEO Professor Alan Trounson AO. "These advanced manufacturing facilities will provide a much needed addition to Victoria's translational capacity in oncology, regenerative medicine and other therapeutic applications."
Advanced Manufacturing Technology Platform
The facility is equipped with comprehensive environmental control systems that monitor particle counts, airflows, air pressures, humidity, and temperature to meet the strict standards required for cell therapy manufacturing. Advanced processing technologies include closed processing systems, bioreactors, cleanroom-grade incubators, and a bioburden testing laboratory to support robust and compliant manufacturing processes.
Cartherics' cell-based immunotherapy platform is built on allogeneic (off-the-shelf) cells derived from induced pluripotent stem cells (iPSCs) generated from donated cord blood. These iPSCs can be differentiated into NK cells, T cells, and other immune system cells. The iPSCs are genetically engineered at specific "safe harbour" genomic sites to provide enhanced function for the derived NK and other immune cells.
Expanding Pipeline and Strategic Focus
Beyond CTH-401, Cartherics maintains a strong pipeline of additional CAR-immune cell products designed to target various cancers including ovarian, triple-negative breast, pancreatic, and other solid tumors. The company is also developing specific NK cell products for severe endometriosis and Alzheimer's disease/traumatic brain injury.
The new facility investment demonstrates Cartherics' commitment to establishing itself as a major player in Victoria's thriving biotechnology sector while strengthening Melbourne's position as a leader in advanced medical manufacturing and translational research. The company's mission centers on transforming care in women's health through innovative off-the-shelf immunotherapies, offering new hope for underserved disease conditions.
