Cell Therapies Releases First Clinical Dose for KOALA CAR T-Cell Trial

COMPANY PROFILE
  • Cell Therapies has manufactured and released the first clinical dose of PMCC-COE-KMA for the KOALA first-in-human trial in relapsed or refractory multiple myeloma.
  • The GMP-licensed manufacturing facility in Melbourne is producing clinical doses of the investigational CAR T-cell therapy developed by Peter MacCallum Cancer Centre and licensed by HaemaLogiX.

Cell Therapies Pty Ltd has manufactured and released the first clinical dose of PMCC-COE-KMA, an investigational CAR T-cell therapy being evaluated in the first-in-human KOALA trial for patients with relapsed or refractory multiple myeloma. The first patient has now been dosed with the therapy.

The therapy was developed by the Peter MacCallum Cancer Centre’s Centre of Excellence in Cellular Immunotherapy and licensed by Australian biotechnology company HaemaLogiX Ltd. The KOALA trial is evaluating the safety and efficacy of PMCC-COE-KMA in patients whose disease no longer responds to standard therapies and who are not currently eligible for other CAR T-cell treatments.

PMCC-COE-KMA is designed to target Kappa Myeloma Antigen (KMA), a receptor found on multiple myeloma cells and absent from healthy immune cells. Researchers aim to assess whether this approach can provide a more targeted anti-myeloma effect while reducing treatment-related toxicities. The therapy received approval from Australia’s Therapeutic Goods Administration (TGA) to proceed into clinical testing.

Cell Therapies is manufacturing the clinical doses at its GMP-licensed cell therapy manufacturing facility in Melbourne, which is co-located with Peter Mac. The Centre of Excellence in Cellular Immunotherapy and HaemaLogiX collaborated to advance the therapy from early-stage development through clinical testing, while further patient enrollment in the KOALA trial is ongoing.

“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.”

Dr. Bev Menner, CEO of Cell Therapies
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