Cell Therapies has manufactured and released the first clinical dose for the KOALA trial, marking the start of a first‑in‑human study evaluating PMCC‑COE‑KMA in relapsed or refractory multiple myeloma.
The first patient has now been dosed with the investigational therapy developed by Peter MacCallum Cancer Centre’s Centre of Excellence in Cellular Immunotherapy and licensed by HaemaLogiX.
The trial will assess safety and efficacy in patients whose disease is no longer responding to standard therapies and who are not eligible for other CAR‑T treatments. PMCC‑COE‑KMA targets Kappa Myeloma Antigen, found on myeloma cells but absent from healthy immune cells.
Cell Therapies manufactures clinical doses at its GMP‑licensed facility co‑located with Peter Mac, enabling a streamlined pathway from research to clinical delivery. Dr Bev Menner, Chief Executive Officer of Cell Therapies, said: “The successful treatment of the first patient in the KOALA trial is a significant achievement for everyone involved and demonstrates the power of bringing together world-class research, clinical expertise and advanced manufacturing capabilities.”
She added: “Cell Therapies is proud to manufacture the clinical product for this pioneering study and to support the translation of innovative Australian science into potential new treatment options for patients with multiple myeloma.”
“This milestone highlights the value of Australia’s cell therapy ecosystem and showcases how partnerships between researchers, biotechnology companies and specialised manufacturers can accelerate the development of next-generation therapies.”
The Centre of Excellence and HaemaLogiX advanced PMCC‑COE‑KMA from early development through TGA approval to begin clinical testing. Professor Simon Harrison, Director of the Centre of Excellence, said: “This investigational therapy aims to deliver a more targeted anti-myeloma effect while sparing the patient’s immune system, potentially reducing side effects that often require careful management.”
He added: “The dosing of the first patient is an important step in evaluating this novel approach, and we look forward to continuing patient enrolment and assessing its potential benefit for people living with multiple myeloma.”
Dr Rosanne Dunn, Chief Scientific Officer at HaemaLogiX, said: “We are delighted with the encouraging results from the first safely treated patient, and very pleased to be moving forward to dosing the second patient at a higher dose of KMCAR T-cell therapy.”
“Seeing this work translate from the laboratory into human trials with positive safety data is a very important step forward for our immunotherapy programs.”
CAR‑T therapy involves collecting, modifying and reinfusing a patient’s T‑cells to attack cancer. The KOALA trial is led by Principal Investigator Dr Mark Dowling, with enrolment ongoing.
