Cartherics, a company developing off-the-shelf immune stem cell therapies with lead programs in ovarian cancer and endometriosis, has unveiled its new, state-of-the-art cleanroom facility for clinical-scale manufacturing of cell therapy products.
Once validated, the facility will be used for manufacturing of clinical batches of the company’s lead cell therapy product, CTH-401, for which the first clinical indication will be relapsed and refractory ovarian cancer.
Cartherics is working towards its mission to transform care in women’s health with innovative off-the-shelf immunotherapies, offering new hope for conditions like ovarian cancer, triple-negative breast cancer, endometriosis, and other underserved diseases. It anticipates submitting an IND for CTH-401 to the US FDA in mid-2026.
Cartherics’ CEO, Professor Alan Trounson AO, said, “The completion of the cleanrooms means that clinical manufacturing can now begin for Cartherics’ therapeutic products targeting ovarian cancer and endometriosis. These advanced manufacturing facilities will provide a much-needed addition to Victoria’s translational capacity in oncology, regenerative medicine and other therapeutic applications.”
Situated in the Ferntree Place Precinct of Notting Hill in Melbourne, the new facility is equipped with comprehensive environmental control systems that monitor particle counts, airflows, air pressures, humidity, and temperature. It incorporates advanced manufacturing technologies, including closed processing systems, bioreactors, cleanroom-grade incubators, and a bioburden testing facility.