• Phase 1 KOALA clinical trial evaluating KMCAR™ T-cell therapy in relapsed/refractory kappa-restricted multiple myeloma now open for patient enrolment
• The KOALA study, underway at Peter Mac’s Centre of Excellence in Cellular Immunotherapy, is the first-in-human evaluation of KMCAR™ T-cell, a novel CAR-T cell therapy, targeting the
  tumour-specific Kappa Myeloma Antigen (KMA)
• KMCAR™ T-cell is based on HaemaLogiX’s KappaMab™ antibody technology, validated across multiple Phase 1, 2a and 2b clinical trials with a favourable safety profile
• Multiple myeloma is the second most common blood cancer worldwide. Despite therapeutic advances, more than half of multiple myeloma patients fail standard-of-care treatment 

HaemaLogiX Ltd is pleased to announce that the KOALA Phase 1 clinical trial is now active and open to patient enrolment at the Peter MacCallum Cancer Centre. The study targets multiple myeloma, the second most common blood cancer worldwide1.

This achievement follows the successful receipt of Clinical Trial Approval (CTA) from Australia’s Therapeutic Goods Administration (TGA) and ethics approval for the study, enabling the transition from pre‑clinical development into clinical evaluation.

The KOALA study is a Phase 1 dose‑escalation trial assessing the safety and preliminary efficacy of KMCAR™ T‑cell, a novel autologous CAR‑T therapy targeting the Kappa Myeloma Antigen (KMA) - a tumour‑specific receptor found only on myeloma cells and absent from healthy immune cells. This unique specificity has the potential to deliver effective tumour killing, while sparing normal immune function, distinguishing KMCAR™ T‑cell therapy from currently approved BCMA‑directed CAR‑T therapies.

KMCAR™ T-cell therapy harnesses and genetically modifies a patient’s own T cells to recognise and destroy cancerous plasma cells that express KMA. The therapy is derived from HaemaLogiX’s proprietary KappaMab™ antibody technology, which has been validated in multiple Phase 1, 2a and 2b clinical trials, demonstrating a favourable safety profile and durable patient responses. Pre‑clinical studies conducted jointly by HaemaLogiX and Peter Mac provided compelling proof‑of‑concept for the CAR‑T modality, showing specific and durable killing of KMA‑positive tumour cells.

Dr Rosanne Dunn, Chief Scientific Officer and Co-Founder of HaemaLogiX, said:

"This milestone reflects years of scientific collaboration and commitment to developing a targeted, tumour‑specific approach for patients with relapsed or refractory multiple myeloma. We are excited to see our KMCAR™ T‑cell therapy progress into clinical testing and look forward to the insights the KOALA study will generate."

Dr Chris Baldwin, CEO, HaemaLogiX, said: 

“The commencement of patient screening and enrolment in the KOALA clinical trial represents a significant milestone at a critical time in the evolution of CAR-T therapies for multiple myeloma. Momentum in the field continues to build, highlighted by the Australian Government’s recent decision to provide eligible patients with free access to Carvykti - a BCMA-targeted CAR-T cell therapy - reinforcing the growing importance of this treatment class. Our KMCAR™ T-cell therapy is differentiated by its ability to target the tumour-specific KMA antigen, and we believe it has the potential to further broaden the therapeutic impact of CAR-T approaches in multiple myeloma.”