Cartherics is proud to announce the successful certification of our new clean room facility, marking a significant milestone in our journey toward delivering off-the-shelf cell therapies for cancer and endometriosis. 

This milestone builds on the recent unveiling of our cleanroom facility, as announced here, and reflects our continued progress in establishing the infrastructure needed to support clinical and commercial cell therapy production. 

This certified facility, designed to meet stringent standards, enhances our in-house capabilities to develop and manufacture advanced immunotherapies at clinical scale. It will be used for manufacturing clinical batches of our lead cell therapy product, CTH-401, for which the first clinical indication will be relapsed and refractory ovarian cancer. 

Cartherics’ CEO, Prof. Alan Trounson AO, commented: “We are looking forward to generating the CAR-iNK cell product for clinical trial studies in ovarian cancer – a product designed and tested in house and now manufactured on-site for making a difference to women’s lives – something we are very proud of.” 

Cartherics is advancing its mission to revolutionise women’s healthcare through the development of innovative off-the-shelf immunotherapies, aiming to bring new treatment options to patients affected by ovarian cancer, triple negative breast cancer, endometriosis, and other historically underserved conditions. The company plans to submit an Investigational New Drug (IND) application for CTH-401 to the U.S. FDA by mid-2026.  

The certification of our clean room underscores our commitment to quality, safety, and accelerating the path to the clinic. It represents a major step forward in translating our innovative science into real-world treatments and positions us to further advance our research and accelerate the development of future clinical programs.